Senior Quality Manager jobs at Allogene Therapeutics

- 292 jobs

Director, Product Quality
Noah Medical 4.1
San Jose, CA jobs
Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. About The Team As part of the Quality team at Noah Medical, you will be at the center of innovation and compliance in medical robotics. We are a dynamic, data-driven, interdisciplinary team of professionals dedicated to surpassing regulatory standards set by the FDA and international bodies. Our team thrives on overcoming hurdles, driving efficiency into our processes, and implementing robust yet agile quality management systems that fosters innovation ensuring that our products make a meaningful difference in patients' lives. Join us in our journey as we continue to set new benchmarks, break barriers, and shape the future of medical robotics. A Day In The Life Of Our Director, Product Quality Regulatory Compliance: Ensure compliance to QA/RA and FDA requirements in all areas of Mfg-Ops Communicate any concerns Support internal QA/RA, QMS, registrar, FDA, State of CA, and other quality and compliance related audits Product Acceptance and Release: Ensure manufacturing processes and products consistently meet internal quality standards and regulatory requirements. Lead all aspects related to product acceptance and release activities. Implement and maintain robust quality control measures to uphold a high standard of product quality. Drive improvement in Manf by at least monthly analyzing NCR data and collaborating with extended team and tracking projects as needed DHR, FQC and PMI: Oversea and improve DHR and PMC process Managing resourcing and timely execution of requirements to Mfg-Ops schedules Ensure needed Product Quality and No Escape of quality issue from Manufacturing Ops Support, Manager, Standardize and Improve product quality at company owned facilities Process Validations and Continuous Improvement: Guide and lead the team during the product development phase, emphasizing process validations. Investigate and address nonconformances promptly to promote a culture of continuous improvement. Manage changes in the manufacturing process with a focus on quality, ensuring proper validation and documentation. Quality Oversight and Program Management: Ensure the quality oversight of manufacturing processes, production test methods/specifications, and finished product release activities. Manage and improve the Product Bioburden program, emphasizing the importance of quality at every stage. Partner with manufacturing to ensure appropriate facilities for the production of medical devices are established and maintained. Collaborate / drive manage effectively, sterilization, contract manufacturers and other suppliers to ensure alignment with quality standards. Collaborate and improve product quality and Mfg OIps Sterility Assurance and Annual Validations: Oversee sterility assurance processes, emphasizing the importance of integrity and sterility in medical devices. Plan, execute, and document annual sterilization validations, reinforcing adherence to regulatory guidelines. Improve overall quality processes associated with Product Quality Team Leadership and Development: Provide visionary leadership to a team of engineers and quality professionals. Foster a culture of continuous improvement and adherence to quality standards. Actively coach and mentor staff on the principles of quality excellence. Establish strong working relationships to ensure product quality at every stage of the manufacturing process. Collaboration and Cross-Functional Projects: Collaborate with cross-functional teams on qualification, process capability, and process improvement projects. Encourage a collaborative approach to quality initiatives. Quality Culture Advocacy: Actively champion a quality culture throughout the organization. Provide hands-on guidance and leadership to instill a commitment to quality in all team members. Participate enthusiastically in QE/QMS activities, contributing to the overall quality culture. Other related duties and assignments not indicated above About You BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent. Minimum of 10 years of work experience in the medical device field with at least 5 years of supervisory or management experience. Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements. Management experience in inspection/test method development and validation. Experience with Risk Analysis, FMEAs, Hazard Analysis, GD & T requirements. Experienced with statistical skills to define/train on test sample size and data analysis techniques. Experienced in Microsoft Office and other software tools such as Google Suite, Jama, and ePLM/eQMS systems, or equivalent. Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication. Preferred but not required: experience with Software Validation, with both disposable/sterile devices and capital/electronic equipment. Certifications: ASQ CQE certifications, 6 Sigma, ISO Auditing, etc., are a plus. #LI-Hybrid Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. California Pay Range $193,000 - $242,000 USD Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + sick time Paid parental leave In-office snacks and beverages In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings. NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
$193k-242k yearly Auto-Apply 56d ago
Quality Program Manager - Heart Institute
Rady Children's Hospital San Diego 4.2
San Diego, CA jobs
The Quality Program Manager (QPM), is responsible for the development and advancement of quality improvement and safety initiatives throughout the Heart Institute (HI) in collaboration with leadership, faculty, and staff. The QPM ensures the achievement of the (HI) and organizational goals in quality improvement, patient safety, and accreditation/regulatory compliance through effective working relationships and partnering with leadership in assigned areas. The QPM develops, leads, plans, organizes, and monitors the quality and performance improvement activities for clinical as well as support and/or administrative services while ensuring that these are in concert with both the RCHSD organizational and patient safety/quality improvement plans. Working closely with the VP - Heart Institute, the QPM is responsible for the planning, oversight, and implementation of all continuous quality improvement initiatives and will develop the strategic clinical improvement strategies for the HI by implementing plans to enhance patient care and safety. The QPM will also identify and establish quality objectives and priorities across the HI and ensure they meet quality standards and are in alignment with the HI strategic plan; Provides recommendations for Medical Director goals to ensure alignment across sub-specialty programs and the HI; Designs and develops data collection, analysis, monitoring, and communicates outcome measures for the HI and acts as a quality expert to the HI data manager and data coordinators; Plans, develops and arranges for quality or safety education for HI faculty and staff to address current gaps in education and training; Designs and provides guidance and educational support to faculty, staff, and leadership on quality improvement methodologies and compliance requirements; Closely collaborates and communicates with the Quality Management department to ensure coordination of work with respect to quality and safety activities. MINIMUM QUALIFICATIONS: Bachelor's Degree 3 Years of Experience in quality assurance and performance improvement, preferably in a healthcare setting California RN License Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Ability to function independently and as a member of a cohesive team Ability to build relationships and collaborate in the achievement of mutual goals Clear and effective communication skills Understanding of, and ability to apply project management and process improvement principles Ability to perform as a quality resource representative to medical staff committees as well as interdisciplinary teams Ability to be flexible in work schedules and coverage of any geographical area of the organization Ability to prioritize workload Ability to utilize critical thinking skills, apply sound principles of decision making and problem-solving processes Analytical skills necessary in order to develop and implement strategic plans and evaluate their effectiveness Ability to organize an agenda, and lead HI discussions Ability to multi-task, pay close attention to details, and resolve problems. Knowledge of regulatory and accreditation agency standards Proficient in data analysis and reporting tools 3 Years of Experience in quality assurance and performance improvement, preferably in a healthcare setting PREFERRED QUALIFICATIONS: 5 Years of Experience Lean Six Sigma Green or Black Belt, The Model of Improvement, or similar quality improvement certification **The current salary range for this position is $52.95 to $72.81** Rady Children's Hospital is committed to compensation that is externally competitive and internally equitable. We demonstrate this commitment by conducting regular market reviews to remain competitive with organizations of similar size in the nonprofit, healthcare sector. The range listed above does not represent the full salary range for the position but is the expected hiring range for qualified candidates. Compensation decisions consider a variety of factors including experience, education, licensure, unique skillsets, organizational need, and internal equity. This posting will remain open from the "date posted" until the hiring manager has determined there is a sufficient applicant pool or until the position is filled. EOE including disability/vet
$53-72.8 hourly 55d ago
Quality Program Manager - Heart Institute
Rady Children's Hospital-San Diego 4.2
San Diego, CA jobs
The Quality Program Manager (QPM), is responsible for the development and advancement of quality improvement and safety initiatives throughout the Heart Institute (HI) in collaboration with leadership, faculty, and staff. The QPM ensures the achievement of the (HI) and organizational goals in quality improvement, patient safety, and accreditation/regulatory compliance through effective working relationships and partnering with leadership in assigned areas. The QPM develops, leads, plans, organizes, and monitors the quality and performance improvement activities for clinical as well as support and/or administrative services while ensuring that these are in concert with both the RCHSD organizational and patient safety/quality improvement plans. Working closely with the VP - Heart Institute, the QPM is responsible for the planning, oversight, and implementation of all continuous quality improvement initiatives and will develop the strategic clinical improvement strategies for the HI by implementing plans to enhance patient care and safety. The QPM will also identify and establish quality objectives and priorities across the HI and ensure they meet quality standards and are in alignment with the HI strategic plan; Provides recommendations for Medical Director goals to ensure alignment across sub-specialty programs and the HI; Designs and develops data collection, analysis, monitoring, and communicates outcome measures for the HI and acts as a quality expert to the HI data manager and data coordinators; Plans, develops and arranges for quality or safety education for HI faculty and staff to address current gaps in education and training; Designs and provides guidance and educational support to faculty, staff, and leadership on quality improvement methodologies and compliance requirements; Closely collaborates and communicates with the Quality Management department to ensure coordination of work with respect to quality and safety activities. MINIMUM QUALIFICATIONS: Bachelor's Degree 3 Years of Experience in quality assurance and performance improvement, preferably in a healthcare setting California RN License Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Ability to function independently and as a member of a cohesive team Ability to build relationships and collaborate in the achievement of mutual goals Clear and effective communication skills Understanding of, and ability to apply project management and process improvement principles Ability to perform as a quality resource representative to medical staff committees as well as interdisciplinary teams Ability to be flexible in work schedules and coverage of any geographical area of the organization Ability to prioritize workload Ability to utilize critical thinking skills, apply sound principles of decision making and problem-solving processes Analytical skills necessary in order to develop and implement strategic plans and evaluate their effectiveness Ability to organize an agenda, and lead HI discussions Ability to multi-task, pay close attention to details, and resolve problems. Knowledge of regulatory and accreditation agency standards Proficient in data analysis and reporting tools 3 Years of Experience in quality assurance and performance improvement, preferably in a healthcare setting PREFERRED QUALIFICATIONS: 5 Years of Experience Lean Six Sigma Green or Black Belt, The Model of Improvement, or similar quality improvement certification The current salary range for this position is $52.95 to $72.81 Rady Children's Hospital is committed to compensation that is externally competitive and internally equitable. We demonstrate this commitment by conducting regular market reviews to remain competitive with organizations of similar size in the nonprofit, healthcare sector. The range listed above does not represent the full salary range for the position but is the expected hiring range for qualified candidates. Compensation decisions consider a variety of factors including experience, education, licensure, unique skillsets, organizational need, and internal equity. This posting will remain open from the "date posted" until the hiring manager has determined there is a sufficient applicant pool or until the position is filled.
$53-72.8 hourly 55d ago
Director, Clinical Quality Assurance
Lyell Immunopharma 4.3
South San Francisco, CA jobs
Using living cells to treat - and sometimes even cure - cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This role is a hybrid role and will be based out of our South San Francisco, California. The individual in this role is responsible for leading and managing our clinical quality systems and ensuring GCP (Good Clinical Practice) compliance across all clinical trial activities. This role will partner across the clinical development organization to establish, maintain, and enhance robust risk-based clinical quality programs that support our investigational products in development. This is a hands-on leadership role suited for someone who thrives in a fast-paced, dynamic environment and is excited to build and optimize quality systems from the ground up. KEY ROLE AND RESPONSIBILITIES: Quality Leadership & Strategy Develop and implement a clinical quality assurance strategy aligned with company goals and regulatory expectations. Serve as the subject matter expert (SME) in GCP and clinical compliance regulations and guidelines (e.g., FDA, EMA, ICH). Provide quality oversight and guidance to cross-functional clinical teams and executive leadership. Audit Program Design, manage, and conduct internal and external GCP audits (e.g., site audits, vendor audits, TMF audits). Oversee audit findings, CAPA development, and follow-up to ensure timely resolution. Collaborate with CROs, vendors, and clinical sites to ensure quality expectations are met. Inspection Readiness Lead clinical inspection readiness activities for regulatory agency inspections. Serve as the CQA representative during inspections, ensuring timely and accurate responses. SOP & Quality System Development Establish and maintain GCP-related SOPs, policies, and quality management systems. Ensure continuous improvement of quality systems, procedures, and training programs. Training & Compliance Provide GCP training and ongoing education to clinical and cross-functional staff. Monitor compliance metrics and identify trends and areas for improvement. Collaboration & Communication Act as the liaison between QA and clinical operations, regulatory affairs, and senior leadership. Partner with external stakeholders (e.g., CROs, vendors) to ensure alignment on quality standards. PREFERRED EDUCATION & EXPERIENCE: BA/BSc in a scientific field with a minimum of 15 years' experience; or MBA or MSc with a minimum of 10 years' experience 10 years of progressive responsibility in Quality Assurance in the Biotechnology industry with at least 5 years' experience in a management or leadership role. Recognized subject matter expert in GCP, GVP, and GCLP and clinical quality systems Demonstrated ability to drive change within organizations. KNOWLEDGE, SKILLS AND ABILITIES: Demonstrated expert knowledge of FDA regulations, and ICH GCP guidelines. Familiarity with EMA and MHRA regulations Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. Experience managing audits and supporting regulatory inspections Strong knowledge of clinical trial processes, oncology and/or cell therapy a plus Ability to work independently and collaboratively among cross-functional teams. Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents. The salary range for this position is $200,000 to $245,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan. Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days' vacation, 9 day's sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.
$200k-245k yearly Auto-Apply 5d ago
Patient Blood Management Programs Manager- FT - Days - Quality
El Camino Hospital 4.4
Mountain View, CA jobs
El Camino Health is committed to hiring, retaining and growing the best and brightest professionals who will carry our mission and vision forward. We are proud of our reputation in the community: One built on compassion, innovation, collaboration and delivering high-quality care. Come join the team that makes this happen. Applicants MUST apply for position(s) by submitting a separate application for each individual job posting number they are interested in being considered for. FTE 1 Scheduled Bi-Weekly Hours 80 Work Shift Day: 8 hours Job Description Form, lead, and facilitate cross functional teams in the planning, developing, coordinating and implementing of complex, enterprise-wide, inpatient and outpatient, performance improvement and/or quality outcome initiatives under the El Camino Health's Patient Blood Management Program. Coach and advise on efforts that will serve to improve efficiency, quality, cost-effectiveness, and the patient experience. Facilitates patient blood management efforts on patient safety, quality or performance improvement teams in collaboration with clinical and non-clinical team leaders and senior leaders. Fosters teamwork to achieve program and organizational goals. The program manager of the Patient Blood Management program serves as the clinical leader for advancing the care of the program-specific patients throughout the organization. The program manager is responsible on achieving and maintaining compliance with the Joint Commission (TJC), American Association of Blood Banks (AABB), and other applicable evidence-based standards. The role leads performance improvement initiatives through application of clinical expertise, knowledge of both clinical and administrative settings and frequent interactions with a variety of clinical and non-clinical roles. The program manager will utilize his/her expertise in enhancing the program, develop evidenced-based practice, education and collaboration, mentoring, and demonstrate change leadership. The program manager coordinates the team's efforts to design, implement, measure, and report-on safe, cost-effective evidence-based care strategies for the Inpatient and Outpatient population across the continuum of care. The program manager conducts comprehensive patient studies to evaluate activities and outcomes, manages policies and protocols, and reviews current best practice through networking and ongoing education. Key Responsibilities * Collaborates with the Clinical Laboratory team and Transfusion Safety Committee to improve the use of evidence-based practice for the Patient Blood Management programs and improve clinical outcomes by leading PI projects, developing education modules, and gap analysis. * Leads, facilitates and collaborates with the multi-disciplinary team across the enterprise to integrate evidence-based practice recommendations into clinical practice and organizational processes. Works directly with service line leaders, medical staff, nursing, and community providers to improve care for the inpatients, outpatients, and perioperative patients. * Maintains current knowledge of patient blood management, both inpatient, outpatient and perioperative, and of current clinical practice /other guidelines and regulatory specifications to include Joint Commission as well as health plan specialty certifications. Remains current on both Joint Commission Patient Blood Management and AABB (American Association Blood Bank) standards on Blood management. * Supervises and controls all program-specific data generation for patient blood management programs including IT/iCare reporting, vendors, patient-reported outcomes, and data registries. Partners with clinical data analysts/staff. Reviews and analyzes data regarding clinical outcomes and regulatory compliance. Provides data and reports to executive and physician leadership, and department directors. Works closely with clinical analysts and IT/iCare staff to develop reports and improve data collection. * Concurrently monitors the program's performance of care on inpatient, outpatient, and perioperative patient care units across the enterprise providing education and intervention with clinical staff and providers as necessary to improve delivery of care. * Provides feedback to the team and/or applicable committees and develops strategies to overcome organizational barriers regarding knowledge, process and interdepartmental collaboration. Additionally, brings frontline staff feedback to the multidisciplinary team. * Demonstrates teamwork and utilizes communication/ influencing expertise to foster collaboration among clinicians and providers and in the adoption of best practices. * Complies with regulatory standards and laws and strives to continue to advance the program. * Demonstrates complex/high-level communication skills. * Plan and directs services to improve clinical outcomes. Works with Director to implement new programs and services. * Complies data and prepares data visualization for both medical and nursing staff to improve performance. Qualifications Bachelor's degree in a work-related field from an accredited college or university or related field; Master's preferred. Three (3) years' experience leading teams in the specialty, preferably in a clinical setting. Knowledge of inpatient, outpatient, perioperative and clinic operations within the specialty. Excellent communication skills, both oral and written, interpersonal, and facilitation skills. Computer proficiency in data base use and data presentation programs including Microsoft office suite programs. Demonstrated ability to produce results and coordinate projects. Proven critical thinking and problem-solving skills with the ability to organize, analyze and present data License/Certification/Registration Requirements RN license required. CPHQ Certification, preferred Certified Clinical Nurse Leader, preferred. Salary Range: $73.68 - $110.52 USD Hourly The Physical Requirements and Working Conditions of this job are available. El Camino Health will provide reasonable accommodations to qualified individuals with a disability if that will allow them to perform the essential functions of a job unless doing so creates an undue hardship for the hospital, or causes a direct threat to these individuals or others in the workplace which cannot be eliminated by reasonable accommodation. Sedentary Work - Duties performed mostly while sitting; walking and standing at times. Occasionally lift or carry up to 10 lbs. Uses hands and fingers. - (Physical Requirements-United States of America) An Equal Opportunity Employer: El Camino Health seeks and values a diverse workforce. The organization is an equal opportunity employer and makes employment decisions on the basis of qualifications and competencies. El Camino Health prohibits discrimination in employment based on race, ancestry, national origin, color, sex, sexual orientation, gender identity, religion, disability, marital status, age, medical condition or any other status protected by law. In addition to state and federal law, El Camino Health also follows all applicable fair and equitable employment policies from the County of Santa Clara.
$73.7-110.5 hourly Auto-Apply 60d+ ago
Quality Patient Safety Program Manager
Dignity Health 4.6
Grass Valley, CA jobs
**Job Summary and Responsibilities** The primary function of the Quality/Patient Safety Program Manager is to support, coordinate, and facilitate the quality management (QM), patient safety (PS) and regulatory performance improvement (PI) activities for the hospital and medical staff. This role also serves as a resource to employees, management, nursing directors, senior management, councils, physicians and teams on quality management activities and will handle patient sensitive and confidential hospital information. + Assists in the design, planning, implementation and coordination of Quality Management, Patient Safety and Performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, root cause analyses and medical staff improvement (e.g. case review for peer review, OPPE, FPPE) **Job Requirements** **Required:** + Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff + (3) years clinical experience in an acute care setting + Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction + One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) + Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required **Where You'll Work** Dignity Health Sierra Nevada Memorial Hospital is a 104-bed not-for-profit hospital located in Grass Valley, California. The hospital has been providing compassionate and quality health care to residents and visitors of western Nevada County since 1958. As an affiliate of the nationally recognized Dignity Health system, we ensure our patients receive the highest standard of health care and have access to important regional resources throughout the system, including the Dignity Health Heart & Vascular Institute, the Dignity Health Neurological Institute of Northern California and the Dignity Health Cancer Institute of Greater Sacramento. With 765 employees, 101 active medical staff and 21 Emergency Department beds, Sierra Nevada Memorial Hospital continually implements and upgrades its technology and recruits employees who understand the vital importance of kindness and compassion in the healing process. One Community. One Mission. One California (********************************** QgPZ6ZWZM60TPV) **Pay Range** $57.37 - $85.33 /hour We are an equal opportunity/affirmative action employer.
$57.4-85.3 hourly 20d ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Sacramento, CA jobs
**Job Summary and Responsibilities** The primary function of the Quality/Patient Safety Program Manager is to support, coordinate, and facilitate the quality management (QM), patient safety (PS) and regulatory performance improvement (PI) activities for the hospital and medical staff. This role also serves as a resource to employees, management, nursing directors, senior management, councils, physicians and teams on quality management activities and will handle patient sensitive and confidential hospital information. + Assists in the design, planning, implementation and coordination of Quality Management, Patient Safety and Performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, root cause analyses and medical staff improvement (e.g. case review for peer review, OPPE, FPPE). + Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. + Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. + Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. Assists with regulatory readiness and survey preparation activities including mock survey tracers. **Job Requirements** **Education and Experience:** + Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff **and** three (3) years clinical experience in an acute care setting + Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction + One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) **Licensure and Certifications:** + Current state license in a clinical field in state of practice + Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required **Required Minimum Knowledge, Skills, Abilities and Training:** + Knowledge and expertise of quality management/performance improvement methods, tools, and techniques (e.g. PDSA, Tests of Change, Six Sigma, LEAN) and ability to create and support an environment that meets the quality goals of the organization. + Current knowledge of data reporting and regulatory/accreditation requirements for acute and ambulatory care services and federal, state and local healthcare related laws and regulations and the ability to comply with these in healthcare practices and activities. + Knowledge of effective self-management practices and ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation. + Understanding of the necessity and value of accuracy and attention to detail. Must be able to review patient records and provide case summaries and maintain the confidentiality of the peer review process. + Knowledge of the techniques and the ability to work with a variety of individuals and groups in a constructive and collaborative manner. + Knowledge of the current situation or issue at hand; ability to take full personal responsibility or ownership for assignments, activities, decisions and results. + Knowledge of techniques and tools that promote effective analysis and the ability to determine the root cause of organizational problems and create alternative solutions that resolve the problems in the best interest of the business. + Ability to work well under pressure and respond to changing needs and complex environments. + Excellent communication skills (oral and written), presentation style, including the ability to concisely present data to leaders, clinicians and staff at all levels of the organization. **Where You'll Work** Built-in 1973, Dignity Health Methodist Hospital of Sacramento is committed to providing daily excellence in health care for residents of Sacramento's southern suburbs, including the Elk Grove, Wilton, and Galt communities. Methodist Hospital is home to a 158 acute-care bed facility with 1,120 employees, 283 medical staff, and 29 Emergency Department beds. Methodist Hospital also owns and operates Bruceville Terrace - a 171-bed, sub-acute skilled nursing long-term care facility adjacent to the hospital that provides care for the elderly, as well as those requiring extended recoveries. Methodist Hospital is home to the Family Medicine Residency Program, an accredited and nationally recognized program which provides resident physicians with specialty training in primary care family medicine. Together, the hospital and residency program implemented a ground-breaking curriculum addressing the identification, treatment, and assistance of human trafficking victims and created a one-of-a-kind health clinic for victims, the Human Trafficking Medical Home. One Community. One Mission. One California (********************************** QgPZ6ZWZM60TPV) **Pay Range** $57.37 - $85.33 /hour We are an equal opportunity/affirmative action employer.
$57.4-85.3 hourly 45d ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Sacramento, CA jobs
Where You'll Work Built in 1973, Dignity Health Methodist Hospital of Sacramento is committed to providing daily excellence in health care for residents of Sacramento's southern suburbs, including the Elk Grove, Wilton, and Galt communities. Methodist Hospital is home to a 158-bed acute care facility with 1,120 employees, 283 medical staff, and 29 Emergency Department beds. Methodist Hospital also owns and operates Bruceville Terrace-a 171-bed skilled nursing and long-term care facility adjacent to the hospital that provides care for the elderly as well as those requiring extended recovery. The hospital is home to the Family Medicine Residency Program, an accredited and nationally recognized program providing resident physicians with specialty training in primary care family medicine. Together, the hospital and residency program developed a pioneering curriculum addressing the identification, treatment, and support of human trafficking victims, establishing the unique Human Trafficking Medical Home clinic. Methodist Hospital's commitment to quality, safety, and clinical excellence has earned numerous recognitions, including: Best Performing Tier 3 Facility for the VTE NPOA FY2025 goal Hospital Level Quality and Patient Safety Award (FY2025) as part of the Clinical Excellence Vision Awards, recognizing the team's dedication to improving outcomes across the ministry American Heart Association's Get With The Guidelines -Stroke Gold Plus Award with Target: Stroke Honor Roll Elite and Target: Type 2 Diabetes Honor Roll distinctions Blue Distinction Center for Orthopedics, highlighting excellence in orthopedic care and patient outcomes Together, these achievements reflect Methodist Hospital's unwavering dedication to compassionate care, innovation, and the highest standards of clinical quality. One Community. One Mission. One California Job Summary and Responsibilities The primary function of the Quality/Patient Safety Program Manager is to support, coordinate, and facilitate the quality management (QM), patient safety (PS) and regulatory performance improvement (PI) activities for the hospital and medical staff. This role also serves as a resource to employees, management, nursing directors, senior management, councils, physicians and teams on quality management activities and will handle patient sensitive and confidential hospital information. Assists in the design, planning, implementation and coordination of Quality Management, Patient Safety and Performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, root cause analyses and medical staff improvement (e.g. case review for peer review, OPPE, FPPE). Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. Assists with regulatory readiness and survey preparation activities including mock survey tracers. Job Requirements Education and Experience: Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff and three (3) years clinical experience in an acute care setting Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) Licensure and Certifications: Current state license in a clinical field in state of practice Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required Required Minimum Knowledge, Skills, Abilities and Training: Knowledge and expertise of quality management/performance improvement methods, tools, and techniques (e.g. PDSA, Tests of Change, Six Sigma, LEAN) and ability to create and support an environment that meets the quality goals of the organization. Current knowledge of data reporting and regulatory/accreditation requirements for acute and ambulatory care services and federal, state and local healthcare related laws and regulations and the ability to comply with these in healthcare practices and activities. Knowledge of effective self-management practices and ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation. Understanding of the necessity and value of accuracy and attention to detail. Must be able to review patient records and provide case summaries and maintain the confidentiality of the peer review process. Knowledge of the techniques and the ability to work with a variety of individuals and groups in a constructive and collaborative manner. Knowledge of the current situation or issue at hand; ability to take full personal responsibility or ownership for assignments, activities, decisions and results. Knowledge of techniques and tools that promote effective analysis and the ability to determine the root cause of organizational problems and create alternative solutions that resolve the problems in the best interest of the business. Ability to work well under pressure and respond to changing needs and complex environments. Excellent communication skills (oral and written), presentation style, including the ability to concisely present data to leaders, clinicians and staff at all levels of the organization. Not ready to apply, or can't find a relevant opportunity? Join one of our Talent Communities to learn more about a career at CommonSpirit Health and experience #humankindness.
$123k-159k yearly est. Auto-Apply 1d ago
Quality Patient Safety Program Manager
Dignity Health 4.6
Carmichael, CA jobs
Where You'll Work Dignity Health Mercy San Juan Medical Center is a 384-bed not-for-profit Level 2 Trauma Center located in Carmichael California. We have served north Sacramento County as well as south Placer County for over 50 years. Our facility is one of the area's largest medical centers and also one of the most comprehensive. Our staff and volunteers are dedicated to community well-being; providing excellent patient care to all. Mercy San Juan Medical Center is a Comprehensive Stroke Center as well as a Spine Center of Excellence. We are proud recipients of the Perinatal Care Certificate of Excellence and a Certificate of Excellence for Hip and Knee Replacements. One Community. One Mission. One California Job Summary and Responsibilities Full Time Day Quality and Patient Safety Program Manager The primary function of the Quality/Patient Safety Program Manager is to support, coordinate, and facilitate the quality management (QM), patient safety (PS) and regulatory performance improvement (PI) activities for the hospital and medical staff. This role also serves as a resource to employees, management, nursing directors, senior management, councils, physicians and teams on quality management activities and will handle patient sensitive and confidential hospital information. Assists in the design, planning, implementation and coordination of QM, PS and PI activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, and root cause analyses and medical staff improvement (e.g. peer review, OPPE, FPPE). Clinical performance improvement, including case review for peer review. Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. Assists with regulatory readiness and survey preparation activities including mock survey tracers. The successful candidate will be familiar with improvement methods, tools and techniques (e.g. PDSA, Tests of Change, Six Sigma, LEAN) and the ability to create and support an environment that meets the quality goals of the organization, along with Root cause analysis, data reporting and familiarity with regulatory/accredidation requirements. #LI-DH #QualityManagementRN #performanceimprovement #healthcarequalitycertificate Job Requirements Education and Experience: Bachelor's degree or five (5) years of related job or industry experience in lieu of degree. One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audits, PI team member, etc.) and three (3) years clinical experience in an acute care setting. Licensure: Current state license in a clinical field in state of practice. Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required. Not ready to apply, or can't find a relevant opportunity? Join one of our Talent Communities to learn more about a career at CommonSpirit Health and experience #humankindness.
$122k-159k yearly est. Auto-Apply 1d ago
Quality Manager, Supplier QA
Veracyte 4.6
South San Francisco, CA jobs
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way - it's about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions. Our Values: We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins We Care Deeply: We embrace our differences, do the right thing, and encourage each other The Position: As the Quality Manager, Supplier QA you will lead the qualification, monitoring, and oversight of Veracyte's Contract Manufacturers (CMOs) and IVD suppliers. You will serve as the primary quality interface between Veracyte and its external manufacturing partners, ensuring that all products and processes meet applicable regulatory requirements (e.g., ISO 13485, FDA QSR, IVDR) and internal quality standards. The ideal candidate brings strong supplier quality experience, auditing, and managing external manufacturing relationships. This is a hybrid role (remote and in office up to 3 days a week as necessary) and is based out of our headquarters in South San Francisco (SSF), California, United States. Responsibilities: Own and lead the Supplier Quality Management to ensure vendor products, processes and services are provided in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte's quality standards. Establish and maintain supplier and CMO oversight strategies, including risk-based qualification, periodic performance monitoring, and quality metrics. Serve as the primary Quality lead for supplier and CMO relationships, providing quality input during supplier selection, qualification, and issue resolution. Lead and execute supplier audits, ensure timely closure of audit findings, and drive continuous improvement across the supplier base. Develop, implement, and maintain supplier quality metrics and monitoring programs. Lead investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance Oversee and maintain the Approved Supplier List (ASL) and associated supplier documentation in compliance with ISO 13485 and IVDR. Lead suppliers and CMOs qualification activities, including risk assessments, audits, and quality agreements Issue, track, and close Supplier Corrective Action Requests (SCARs) related to supplier non-conformances Review and approve supplier change notifications and deviations to assess the impact on product quality and regulatory compliance. Ensure appropriate validation and verification activities are performed for supplier-initiated changes Collaborate cross-functionally with R&D, Regulatory Affairs, and Supply Chain to support new product introductions and design transfers to CMOs. Support regulatory inspections and notified body audits, serving as the SME for supplier quality. Champion continuous improvement initiatives to strengthen supplier quality processes and reduce external quality risk. Who You Are: Qualifications: Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field A minimum of 6 - 7 years of progressive experience in Quality Assurance within the medical device or IVD industry. In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management Prior experience in implementing and establishing a Supplier Quality program that is compliant to ISO13485 and IVDR requirements Demonstrated success in supplier quality leadership, audit execution, and external manufacturing oversight. Willingness to travel (up to ~30%) to supplier and CMO sites. Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses Strong organization skills to manage multiple simultaneous projects in a fast-paced environment. Attention to detail in understanding and documenting complex quality issues Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment. ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred #LI-Hybrid The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to years of experience, skillset, geographic location, industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Pay range$128,000-$149,000 USDWhat We Can Offer You Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified™ Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose. About Veracyte Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit **************** or follow us on LinkedIn or X (Twitter). Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice. If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to ********************
$128k-149k yearly Auto-Apply 3d ago
Director, Quality Operations
Cytokinetics, Incorporated 4.5
South San Francisco, CA jobs
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is seeking a highly motivated individual to join our team as Director of Quality Assurance with responsibility for oversight of Quality Control activities. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch! The Director, QA will provide strategic leadership and QA oversight of all Quality Control (QC) generated data within the pharmaceutical manufacturing environment, with a key focus on data integrity, stability program governance, and compliant product release. This is not a QC role, but a QA leadership role to ensure that QC data management across internal and external (CMO) networks aligns with global regulatory expectations and corporate quality standards. The Director partners with Global Supply Chain and Technical Operations Analytical groups, Regulatory Affairs, and external testing sites to maintain the highest level of quality and data reliability supporting clinical and commercial products. Responsibilities: * Provide strategic leadership and quality governance for QC data oversight programs, establishing standards to ensure global compliance, accuracy, and data integrity. * Lead QA oversight for product stability and lot release programs, ensuring alignment with cGMP, FDA, EMA, and ICH expectations. * Develop, implement, and continuously improve governance frameworks for analytical data review and trending across internal teams and CMOs. * Direct QA review strategies for critical QC deliverables, including analytical trends, OOS and OOT investigations, and product shelf-life assessments. * Chair or co-lead cross-functional forums to ensure proactive identification and mitigation of analytical or stability risks. * Provide final QA endorsement for CoAs to support product disposition decisions. Ensure robust processes are in place for review and approval by QA. * Oversee QA partner engagement with CMOs and testing laboratories to ensure alignment with quality agreements, stability plans, and regulatory guidelines. * Serve as subject matter leader in QA oversight of data review, stability programs, and batch release data, with the potential opportunity to build and mentor a team as the function expands. * Guide cross-functional teams in readiness for global regulatory inspections; act as primary QA representative and SME in data integrity, and stability and batch release data compliance. * Collaborate with Regulatory Affairs and Technical Operations to support CMC submissions and responses to health authority queries related to analytical data. * Oversee monitoring and reporting of stability metrics and quality performance indicators to senior leadership. * Lead continuous improvement initiatives to strengthen QA oversight processes and analytical data life-cycle management. Minimum qualifications: * Bachelor's Degree in a scientific or technical discipline with 7+ years' experience in the biopharmaceutical or pharmaceutical industry with at least 5 years of experience within QA/QC. Advanced degree (MS, PhD) is a plus. * Ability to work in a collaborative team environment is essential. * Experience with clinical/ commercial QC / stability programs. * Knowledge of US and EU cGMP regulations/guidance. * Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. * Effective communication skills, both verbal and written. * Must have strong analytical and interpersonal communication skills. * Experience writing, reviewing and editing SOPs and specifications. * Experience using electronic Quality Management Systems is a plus. * Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus. #LI-HYBRID Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $216,000 -$252,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: * We do not conduct job interviews through non-standard text messaging applications * We will never request personal information such as banking details until after an official offer has been accepted and verified * We will never request that you purchase equipment or other items when interviewing or hiring * If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ********************************** Please visit our website at: ******************** Cytokinetics is an Equal Opportunity Employer
$216k-252k yearly Auto-Apply 57d ago
Director, Quality Operations
Cytokinetics 4.5
South San Francisco, CA jobs
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is seeking a highly motivated individual to join our team as Director of Quality Assurance with responsibility for oversight of Quality Control activities. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch! The Director, QA will provide strategic leadership and QA oversight of all Quality Control (QC) generated data within the pharmaceutical manufacturing environment, with a key focus on data integrity, stability program governance, and compliant product release. This is not a QC role, but a QA leadership role to ensure that QC data management across internal and external (CMO) networks aligns with global regulatory expectations and corporate quality standards. The Director partners with Global Supply Chain and Technical Operations Analytical groups, Regulatory Affairs, and external testing sites to maintain the highest level of quality and data reliability supporting clinical and commercial products. Responsibilities: Provide strategic leadership and quality governance for QC data oversight programs, establishing standards to ensure global compliance, accuracy, and data integrity. Lead QA oversight for product stability and lot release programs, ensuring alignment with cGMP, FDA, EMA, and ICH expectations. Develop, implement, and continuously improve governance frameworks for analytical data review and trending across internal teams and CMOs. Direct QA review strategies for critical QC deliverables, including analytical trends, OOS and OOT investigations, and product shelf-life assessments. Chair or co-lead cross-functional forums to ensure proactive identification and mitigation of analytical or stability risks. Provide final QA endorsement for CoAs to support product disposition decisions. Ensure robust processes are in place for review and approval by QA. Oversee QA partner engagement with CMOs and testing laboratories to ensure alignment with quality agreements, stability plans, and regulatory guidelines. Serve as subject matter leader in QA oversight of data review, stability programs, and batch release data, with the potential opportunity to build and mentor a team as the function expands. Guide cross-functional teams in readiness for global regulatory inspections; act as primary QA representative and SME in data integrity, and stability and batch release data compliance. Collaborate with Regulatory Affairs and Technical Operations to support CMC submissions and responses to health authority queries related to analytical data. Oversee monitoring and reporting of stability metrics and quality performance indicators to senior leadership. Lead continuous improvement initiatives to strengthen QA oversight processes and analytical data life-cycle management. Minimum qualifications: Bachelor's Degree in a scientific or technical discipline with 7+ years' experience in the biopharmaceutical or pharmaceutical industry with at least 5 years of experience within QA/QC. Advanced degree (MS, PhD) is a plus. Ability to work in a collaborative team environment is essential. Experience with clinical/ commercial QC / stability programs. Knowledge of US and EU cGMP regulations/guidance. Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. Effective communication skills, both verbal and written. Must have strong analytical and interpersonal communication skills. Experience writing, reviewing and editing SOPs and specifications. Experience using electronic Quality Management Systems is a plus. Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus. #LI-HYBRID Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $216,000 -$252,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ********************************** Please visit our website at: ******************** Cytokinetics is an Equal Opportunity Employer
$216k-252k yearly Auto-Apply 60d+ ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Los Angeles, CA jobs
**Job Summary and Responsibilities** Are you a licensed healthcare professional with a passion for elevating standards and impacting patient lives? We're actively seeking a Quality Patient Safety Program Manager, Licensed. We rely on meticulous individuals. Your commitment to accuracy and attention to detail will shine through as you review patient records, distill complex information into clear case summaries, and rigorously uphold the confidentiality inherent in the peer review process. Success in this role hinges on your collaborative spirit. You'll work seamlessly with diverse groups, fostering productive relationships and building consensus around critical quality and safety initiatives. **Job Requirements** + Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff, and three (3) years clinical experience in an acute care setting required. + Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction required. + One (1) year of healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) required. + CA License in the clinical field of practice. + Certified Professional in Healthcare Quality (CPHQ), Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required. + Fire Safety required. (must obtain within 90 days from start date) Required Knowledge & Skills + Knowledge and expertise of quality management/performance improvement methods, tools, and techniques (e.g., PDSA, Tests of Change, Six Sigma, LEAN) and ability to create and support an environment that meets the quality goals of the organization. + Current knowledge of data reporting and regulatory/accreditation requirements for acute and ambulatory care services, and federal, state, and local healthcare-related laws and regulations, and the ability to comply with these in healthcare practices and activities. + Knowledge of effective self-management practices and ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation. + Understanding of the necessity and value of accuracy and attention to detail. Must be able to review patient records and provide case summaries, and maintain the confidentiality of the peer review process. + Knowledge of the techniques and the ability to work with a variety of individuals and groups constructively and collaboratively. + Knowledge of the current situation or issue at hand; ability to take full personal responsibility or ownership for assignments, activities, decisions, and results. + Knowledge of techniques and tools that promote effective analysis and the ability to determine the root cause of organizational problems and create alternative solutions that resolve the problems in the best interest of the business. + Ability to work well under pressure and respond to changing needs and complex environments. + Excellent communication skills (oral and written), presentation style, including the ability to concisely present data to leaders, clinicians, and staff at all levels of the organization **Where You'll Work** Founded in 1955, Dignity Health - Northridge Hospital Medical Center is a 394-bed, acute care, nonprofit community hospital located in Northridge, California. The hospital offers a full complement of award winning services, including the Leavey Cancer Center, a cardiovascular center, stroke center, the Center for Assault Treatment Services, a pediatric medical center, and the only pediatric trauma center in the San Fernando Valley. As a leading provider of compassionate, high-quality and affordable patient-centered care, we share a rich legacy with Dignity Health, one of the nation's five largest health care systems. We are part of a 21-state network of nearly 9,000 physicians, 62,000 employees and more than 400 care centers. Visit here (******************************************** dignityhealth.org/northridgehospital for more information. One Community. One Mission. One California (********************************** QgPZ6ZWZM60TPV) **Pay Range** $54.52 - $81.10 /hour We are an equal opportunity/affirmative action employer.
$54.5-81.1 hourly 60d+ ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Los Angeles, CA jobs
**Job Summary and Responsibilities** ****We are offering to qualified and experienced candidates a sign-on bonus not to exceed 10% of salary for this position.**** We've been providing acute care services to DTLA for more than 130 years. Now, we're expanding with the opening of our new patient tower, Grand Tower, featuring a dramatically expanded Emergency Department and Family Birth Center. Thoughtfully designed with increased patient comfort and privacy. **The expansion includes:** + 6 trauma bays-to care for the most seriously injured patients + 47 exam rooms-to reduce wait times + Expanded patient capacity-to support more people in need and decrease ambulance diversions + Dedicated ED pediatric rooms-keeping families with young children separate from traumatically injured patients + Dedicated waiting areas for families to provide a calm, soothing environment + Convenient ER online scheduling and real-time updates from your mobile phone We are seeking a highly analytical and detail-oriented Licensed **Quality Patient Safety Program Manager** to join our dedicated Quality & Patient Safety team. In this pivotal role, you will be instrumental in supporting our continuous drive for excellence in patient care, especially as we launch and optimize operations within the new Grand Tower. You will leverage your expertise in data management, analysis, and reporting to identify insights, support quality initiatives, and contribute to tangible improvements in patient safety, experience, and operational effectiveness across the organization. **Principal Duties and Accountabilities:** + Assists in the design, planning, implementation and coordination of Quality Mgmt., Patient Safety and Performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, and root cause analyses and medical staff improvement (e.g. OPPE, FPPE). + Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. + Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. + Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. Assists with regulatory readiness and survey preparation activities including mock survey tracers. + Directors programs involving risk mitigation/management and initiatives related to providing safer care to patients. This position is responsible for providing information to various key stakeholders on the progress and status of described programs/initiatives. + Oversees the implementation of compliance policies and procedures to ensure that they meet organization's compliance requirements. Has management responsibility and accountability for the hospitals' overall compliance with regulations from The Joint Commission Department of Health Services CMS and other regulatory agencies. + Oversees the events reporting process root cause analysis and event investigation/review. Participates in system office initiatives and programs to mitigate risks identified at other hospitals resulting in reduced costs and adverse patient outcomes. + Receives and oversees responses to patient complaints and investigates to solve issues promptly. Acts as an intermediary between patients staff and family to provide clear communication between all parties regarding any outstanding issues **Job Requirements** + Bachelor's degree, or five (5) years of related job or industry experience in lieu of degree. + Current state license in a clinical field in state of practice. + Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within two (2) years of employment is required. + One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audits, PI team member, etc.) + Three (3) years clinical experience in an acute care setting **Where You'll Work** Founded in 1887 Dignity Health - California Hospital Medical Center is a 392-bed acute care nonprofit hospital located in downtown Los Angeles. The hospital offers a full complement of services including a Level II trauma center the Los Angeles Center for Womens Health obstetrics and pediatric services and comprehensive cardiac and surgical services. The hospital shares a legacy of humankindness with Dignity Health one of the nations five largest health care systems. Visit **************************************************************** for more information. **Pay Range** $54.52 - $81.10 /hour We are an equal opportunity/affirmative action employer.
$54.5-81.1 hourly 36d ago
RN Quality Patient Safety Program Manager
Dignity Health 4.6
Santa Cruz, CA jobs
**Job Summary and Responsibilities** **SIGN-ON BONUS AND RELOCATION BONUS ELIGIBLE!** **JOB SUMMARY / PURPOSE** The primary function of the Quality/Patient Safety Program Manager Clinical License is to support, coordinate, and facilitate the quality management (QM), patient safety (PS) and regulatory performance improvement (PI) activities for the hospital and medical staff. This role also serves as a resource to employees, management, nursing directors, senior management, councils, physicians and teams on quality management activities and will handle patient sensitive and confidential hospital information. **ESSENTIAL KEY JOB RESPONSIBILITIES** + Assists in the design, planning, implementation and coordination of quality management, patient safety and performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. + Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, root cause analyses and medical staff improvement (e.g. case review for peer review, OPPE, FPPE). + Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. + Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. + Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. + Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. + Assists with regulatory readiness and survey preparation activities including mock survey tracers. **Job Requirements** **MINIMUM QUALIFICATIONS:** **Required Education:** + Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff and three (3) years clinical experience in an acute care setting + Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction + One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) **Required Licensure and Certifications:** + Current state license in a clinical field in state of practice. + Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required. **Where You'll Work** **Dominican Hospital** (a member of Dignity Health) is a 222-bed facility that offers a wide range of services to residents of California's Central Coast. With 24/7 emergency care comprehensive care in cardiac orthopedics oncology women's and children's services we continue to lead the region in medical innovation and excellence in healthcare. Comprehensive CareDominican offers emergency services and is a Certified Stroke Center and Chest Pain Center. Dominican's services include the only comprehensive Cancer Center in Santa Cruz County a Total Joint Replacement program and advanced neurological and endoscopic services. Dominican regularly receives 'A' grades for hospital safety from Leapfrog Group and has received national recognition for superior patient safety cardiac care and stroke treatment from Healthgrades a leading provider of comprehensive information about physicians and hospitals.As Santa Cruz County's heart attack (STEMI) receiving center Dominican Hospital provides cutting edge cardiac care. The hospital's heart attack treatment times consistently beat the national average and the hospital offers two cardiac catheterization labs available 24 hours a day 7 days a week. Groundbreaking cardiac procedures at Dominican include the Transcatheter Aortic Valve Replacement (TAVR) procedure which allows for heart valve replacement without opening a patient's chest.Dominican Hospital has forged significant partnerships with area hospitals to bring exceptional care to Santa Cruz County. The hospital offers a level III Neonatal Intensive Care Unit (NICU) through a partnership with Lucile Packard Children's Hospital Stanford. Neurosurgery at Dominican is also offered through a partnership with Stanford Health Care. **Pay Range** $62.58 - $93.09 /hour We are an equal opportunity/affirmative action employer.
$62.6-93.1 hourly 60d+ ago
Director of Quality and Population Health
DAP Health 4.0
Escondido, CA jobs
At DAP Health, we are committed to transforming lives and advancing health equity for all. As a leading nonprofit health care provider, we deliver compassionate, high-quality care to the diverse communities of the Coachella Valley and San Diego County. Our comprehensive services range from primary care to mental health, wellness programs, and beyond, with a focus on those who are most vulnerable. Joining our team means becoming part of a passionate, innovative organization dedicated to making a meaningful impact in the lives of those we serve. If you're looking for a dynamic and purpose-driven environment, we invite you to explore the opportunity to contribute to our mission. Job Summary The Director of Quality and Population Health is responsible for the overall coordination and implementation of the Quality Program. This will include collection, management, analysis and interpretation of quality data and the preparation of quality reports. This role will facilitate change through project management (planning, measuring, analyzing, implementing, training, coaching, change management and evaluating) of QI initiatives throughout all areas of the organization, with the goal to improve quality and efficiency of clinical services and operations. This position will have the overall responsibility of meeting the requirements of Patient Centered Medical Home recognition. FTE: Full-time, Salaried Onsite (Hybrid Optional) Supervisory Responsibilities Provide staff supervision and in-service training, as appropriate. Provide leadership to Quality Improvement, Risk Management, and Infection Control. Collaborate in the completion of Quality staff hiring and the completion of performance evaluations. Review weekly timesheets for accuracy, review employee submissions and updates as needed; approve timesheets by required timeline Conduct one-on-one meetings (monthly at a minimum frequency, preferably bi-weekly), scheduled conversations, and annual performance reviews with direct reports by required timeline Attend mandatory Manager's Learning Collaborative trainings Partner with People Operations to: Develop a learning plan for employee development goals to provide tools needed to excel in their position Implement and follow a process to address performance issues as they arise Prepare a comprehensive onboarding process for each specific position for all new hires Address serious issues that may require interventions or investigations Develop and monitor departmental and program/project operating budgets, costs and schedules Supervise, lead, coach, and use best management practices to improve staff performance Support and model the identified vision, values, and behaviors of the organization Other supervisory tasks as assigned Essential Duties/Responsibilities Assist in the implementation and monitoring of progress of DAP Health's Quality Work plan and provide support to stakeholders Responsible for participating in the development of quality related strategic plans, policies, and procedures at all levels of the organization Responsible for the adoption and sustainability of a Patient Centered Medical Home model of care Assist with the implementation and integration of quality process improvement efforts that will meet or exceed internal and external customers' needs and expectations Collaborate in the development of grant related health and business plans as well as grant reporting requirements In collaboration with the Finance Department, responsible for the submission of the annual Unified Data Systems (UDS) report and other reports required by our funder, the Health Resource Service Administration (HRSA) Produce reports from different databases as needed Coordinate tracking and reporting of quality work plan goals and clinical outcomes, and follow-up of corrective action plans Develop methods for data collection and extract data as required Provide in-service training to non-provider staff in the area of quality improvement Develop an education curriculum that focuses on quality improvement methodology and tools as well as coordinate administration of training Review QI tools and surveys and provide technical assistance to staff Facilitate, communicate, and administer quality measurement activities. Apply statistical techniques to track and trend issues/results Regularly monitor and report results of patient satisfaction surveys Develop systems to measure and regularly monitor operational metrics such as access (telephone appointment access audit, third next available appointment), efficiency (Cycle time), continuity of care (PCP continuity), and panel management (panel size) Participate in internal and external committees as position requires Supervise Internal Quality Monitoring activities and the preparation of quarterly and annual Quality Monitoring reports (Internal/External), aggregating data analyzing trends and working collaboratively with program staff regarding follow-up activities andimprovements, as required Facilitate Performance and Outcome Measurement activities and the submission of Outcome Measurement reports, including tracking key indicators throughout the year, aggregating data, analyzing quarterly and annual trends, and working collaboratively with program staff regarding follow-up activities and improvements, as required Lead Quality Department meetings Communicate results and recommendations to key audiences, including the presentation of Quality Improvement reports to staff with analysis of trends Ensure recording of minutes, as appropriate Collaborate with other departments agency wide Enhance self-knowledge of quality initiatives through reading and participation in seminars, workshops, etc. Supervise and coordinate Quality Department Staff in developing, implementing, and evaluating assigned QI activities and projects Communicate information from meetings, conferences, and committees to Quality Improvement staff Oversee staff, tasks, and scheduling, ensuring task completion Perform other duties and assumes responsibilities as assigned Required Skills/Abilities * Excellent interpersonal communication and presentation skills * Effective leadership skills * Ability to approach staff about quality issues with tact and diplomacy * Understanding of diverse populations, demonstrating compassion and understanding * Excellent organizational skills in independently managing workload * Attention to detail in data gathering and presentation * Ability to multi-task * Team player - willing to learn, assist, and help other team members as required * Ability to use office equipment, i.e. copier, fax * Knowledge of basic math skills * Competency in data collection, analysis, and presentation Education and Experience * Bachelor's degree (preferably in a health-related profession such as nursing) or experience leading a quality improvement program. Master's degree in human services, social work, health care administration, public administration, public health or similar field, preferred. * At least 3 years of progressive experience in quality improvement in a health care facility, preferably with a federally qualified health center (FQHC) * At least 5 years supervisory experience * Experience with electronic health records * Experience in the use of spreadsheets (e.g. Excel) for QI-related data management and display * Experience with computer database and word-processing programs such as Office Suite Word, Excel, and Access-to create and maintain databases [e.g. "Access"], track and analyze information, is desirable Working Conditions/Physical Requirements * Position is 50% onsite at various DAP Health clinics in the San Diego & Riverside Counties. * Available for all shifts and, when required, able to work evenings and weekends * This job operates in an office setting and requires frequent times of sitting, standing, repetitive motion and talking * Ability to lift to 40 pounds and move from place to place * Requires current and valid driver's license and current personal auto insurance * Able to travel to DAP Health locations throughout San Diego and the Coachella Valley * Ensures compliance with policies and procedures related to safe work practices
$135k-173k yearly est. 2d ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Los Angeles, CA jobs
Where You'll Work Founded in 1887 Dignity Health - California Hospital Medical Center is a 392-bed acute care nonprofit hospital located in downtown Los Angeles. The hospital offers a full complement of services including a Level II trauma center the Los Angeles Center for Womens Health obstetrics and pediatric services and comprehensive cardiac and surgical services. The hospital shares a legacy of humankindness with Dignity Health one of the nations five largest health care systems. Visit **************************************************************** for more information. Job Summary and Responsibilities **We are offering to qualified and experienced candidates a sign-on bonus not to exceed 10% of salary for this position.** We've been providing acute care services to DTLA for more than 130 years. Now, we're expanding with the opening of our new patient tower, Grand Tower, featuring a dramatically expanded Emergency Department and Family Birth Center. Thoughtfully designed with increased patient comfort and privacy. The expansion includes: 6 trauma bays-to care for the most seriously injured patients 47 exam rooms-to reduce wait times Expanded patient capacity-to support more people in need and decrease ambulance diversions Dedicated ED pediatric rooms-keeping families with young children separate from traumatically injured patients Dedicated waiting areas for families to provide a calm, soothing environment Convenient ER online scheduling and real-time updates from your mobile phone We are seeking a highly analytical and detail-oriented Licensed Quality Patient Safety Program Manager to join our dedicated Quality & Patient Safety team. In this pivotal role, you will be instrumental in supporting our continuous drive for excellence in patient care, especially as we launch and optimize operations within the new Grand Tower. You will leverage your expertise in data management, analysis, and reporting to identify insights, support quality initiatives, and contribute to tangible improvements in patient safety, experience, and operational effectiveness across the organization. Principal Duties and Accountabilities: Assists in the design, planning, implementation and coordination of Quality Mgmt., Patient Safety and Performance Improvement activities for assigned hospital and medical staff departments, committees, divisions, service lines and functions. Proactively coordinates and facilitates performance improvement teams to support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, efficiency, FMEAS, and root cause analyses and medical staff improvement (e.g. OPPE, FPPE). Participates in an integral role to ensure compliance with CMS HIQRP/HOQRP, TJC, Leapfrog, etc., data collection and reporting of process and outcome measures. Facilitates development and implementation of data collection tools and processes including the ability to: identify data elements needed to complete appropriate measurement, perform data collection and abstraction per specifications, and validate data prior to submission or preview reports prior to publication. Facilitates meetings, presents data and reports, identifies key findings and assists with action plans and implementation. Maintains current knowledge of accreditation and licensing requirements and must be a resource to staff on these regulations in order to improve management of outcomes and ensure compliance. Assists with regulatory readiness and survey preparation activities including mock survey tracers. Directors programs involving risk mitigation/management and initiatives related to providing safer care to patients. This position is responsible for providing information to various key stakeholders on the progress and status of described programs/initiatives. Oversees the implementation of compliance policies and procedures to ensure that they meet organization's compliance requirements. Has management responsibility and accountability for the hospitals' overall compliance with regulations from The Joint Commission Department of Health Services CMS and other regulatory agencies. Oversees the events reporting process root cause analysis and event investigation/review. Participates in system office initiatives and programs to mitigate risks identified at other hospitals resulting in reduced costs and adverse patient outcomes. Receives and oversees responses to patient complaints and investigates to solve issues promptly. Acts as an intermediary between patients staff and family to provide clear communication between all parties regarding any outstanding issues Job Requirements Bachelor's degree, or five (5) years of related job or industry experience in lieu of degree. Current state license in a clinical field in state of practice. Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within two (2) years of employment is required. One (1) year healthcare-related quality management/performance improvement experience (e.g., chart audits, PI team member, etc.) Three (3) years clinical experience in an acute care setting Not ready to apply, or can't find a relevant opportunity? Join one of our Talent Communities to learn more about a career at CommonSpirit Health and experience #humankindness.
$112k-146k yearly est. Auto-Apply 60d+ ago
Quality Patient Safety Program Manager Licensed
Dignity Health 4.6
Los Angeles, CA jobs
Where You'll Work Founded in 1955, Dignity Health - Northridge Hospital Medical Center is a 394-bed, acute care, nonprofit community hospital located in Northridge, California. The hospital offers a full complement of award winning services, including the Leavey Cancer Center, a cardiovascular center, stroke center, the Center for Assault Treatment Services, a pediatric medical center, and the only pediatric trauma center in the San Fernando Valley. As a leading provider of compassionate, high-quality and affordable patient-centered care, we share a rich legacy with Dignity Health, one of the nation's five largest health care systems. We are part of a 21-state network of nearly 9,000 physicians, 62,000 employees and more than 400 care centers. Visit here dignityhealth.org/northridgehospital for more information. One Community. One Mission. One California Job Summary and Responsibilities Are you a licensed healthcare professional with a passion for elevating standards and impacting patient lives? We're actively seeking a Quality Patient Safety Program Manager, Licensed. We rely on meticulous individuals. Your commitment to accuracy and attention to detail will shine through as you review patient records, distill complex information into clear case summaries, and rigorously uphold the confidentiality inherent in the peer review process. Success in this role hinges on your collaborative spirit. You'll work seamlessly with diverse groups, fostering productive relationships and building consensus around critical quality and safety initiatives. Job Requirements Licensed Registered Nurse, Licensed Clinical Pharmacist, or other Licensed Clinical Staff, and three (3) years clinical experience in an acute care setting required. Must be able to perform case reviews for medical staff peer review and medical and/or surgical Registry Abstraction required. One (1) year of healthcare-related quality management/performance improvement experience (e.g., chart audit, PI team member, etc.) required. CA License in the clinical field of practice. Certified Professional in Healthcare Quality (CPHQ), Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required. Fire Safety required. (must obtain within 90 days from start date) Required Knowledge & Skills Knowledge and expertise of quality management/performance improvement methods, tools, and techniques (e.g., PDSA, Tests of Change, Six Sigma, LEAN) and ability to create and support an environment that meets the quality goals of the organization. Current knowledge of data reporting and regulatory/accreditation requirements for acute and ambulatory care services, and federal, state, and local healthcare-related laws and regulations, and the ability to comply with these in healthcare practices and activities. Knowledge of effective self-management practices and ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation. Understanding of the necessity and value of accuracy and attention to detail. Must be able to review patient records and provide case summaries, and maintain the confidentiality of the peer review process. Knowledge of the techniques and the ability to work with a variety of individuals and groups constructively and collaboratively. Knowledge of the current situation or issue at hand; ability to take full personal responsibility or ownership for assignments, activities, decisions, and results. Knowledge of techniques and tools that promote effective analysis and the ability to determine the root cause of organizational problems and create alternative solutions that resolve the problems in the best interest of the business. Ability to work well under pressure and respond to changing needs and complex environments. Excellent communication skills (oral and written), presentation style, including the ability to concisely present data to leaders, clinicians, and staff at all levels of the organization Not ready to apply, or can't find a relevant opportunity? Join one of our Talent Communities to learn more about a career at CommonSpirit Health and experience #humankindness.
$112k-146k yearly est. Auto-Apply 3d ago
Quality Manager
Rani Therapeutics 4.5
Fremont, CA jobs
GENERAL INFORMATION Quality Manager - Medical Device / Combination Product Department: Quality Reports to: VP of Quality Purpose of the job Lead and manage quality assurance processes in the development and manufacturing of combination products (drug-device), ensuring operational effectiveness, regulatory compliance, and robust application of design control and engineering fundamentals. The Quality Manager serves as the key quality lead in cross-functional teams, collaborating with engineering, production, clinical and regulatory partners. The ideal candidate will have working knowledge in the design control requirements for medical device and hands-on experience in product life cycle, from feasibility prototype through product commercialization. The candidate will provide quality and compliance input to the project team for project decisions and deliverables (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team. Major Duties and Responsibilities Team Leadership Mentor, develop, and supervise a multidisciplinary quality team, including quality engineers, specialists, and inspectors. Set clear objectives and performance expectations, provide regular feedback, and drive a culture of accountability, empowerment, and continuous learning. Oversee calibration and preventive maintenance program. Lead by example, inspiring commitment to quality across the organization. Cross-functional Collaboration Serve as the quality lead for multidisciplinary teams (R&D, regulatory, manufacturing, engineering, supply chain), ensuring quality requirements are integrated at every product stage. Facilitate effective communication and alignment, resolve conflicts proactively, and drive collaborative problem-solving. Support and influence cross-functional projects, including but not limited to design control design and product transfer. Quality Assurance & Compliance Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles. Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations. Oversee compliance for combination device development life cycles according to FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR, and other regulatory body regulations and guidelines. Provide QA oversight for development projects and changes to existing products. Support internal and external audits, CAPA and NCMRs. Design Control & Engineering Support Apply knowledge of design control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, design verification & validation, process characterization & validation, component qualification. Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR requirements, and ISO 14971. Work with R&D in the creation of requirements for new products and engineering specifications. Evaluate product changes for qualification and validation requirements and assist in change implementations. Risk, Validation, and Process Management Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies. Lead risk management activities and participate in cross-functional teams to develop and maintain product risk management files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.). Lead test method validation activities and Gage R&R studies for Combination Product. Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports. Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Other duties/ activities may be necessary to support departmental or company goals. Education and/or Job Experience A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required. BS degree in Mechanical Engineering or related field is required. A minimum of 3 years of experience supervising employees Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, EU MDR, ISO 13485. Experience with Risk Management process per ISO 14971 (Risk Management Plan/Report, FMEA's). Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation). Must be a self-starter and capable of working independently and within a team. Experience performing statistical analysis (Six Sigma preferred). CQE, CQA preferred. Skills and Specifications Ability to motivate and influence people. Must possess the ability to handle multiple tasks with high attention to detail, planning, and problem-solving skills. Good interpersonal and communication skills. Ability to work as a part of a team. Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate. recommendations and decisions; write reports. Ability to create and provide training. Good statistical and numerical ability.
$102k-153k yearly est. 8d ago
Production & Quality Manager
Parachute Health 4.5
Los Angeles, CA jobs
Summary: We are seeking a highly organized and detail-oriented Manager of Production & Quality to lead global production operations and ensure the highest product standards for Parachute. This role will oversee vendor production timelines, enforce quality standards, and drive operational excellence across multiple product categories. The ideal candidate has deep experience in home textiles or consumer goods production, strong vendor management skills, and a passion for delivering products that embody Parachute's commitment to comfort, craftsmanship, and quality. Reports to: VP, Sourcing Location: Culver City, CA - in office M-TH What You'll Do: Production Management Understand the end to end production process of our core products Develop the PO placement calendar to ensure on-time delivery of finished goods. Partner with Planning to ensure projections align with supplier MOQs, Lead times, and launch calendar Evaluate and track projections against raw material inventory Manage end-to-end production processes with global vendors, ensuring capacity planning and workflow efficiency. Partner with Sourcing, Planning, and Merchandising teams to ensure production aligns with design intent, cost targets, and sustainability goals. Temporary Maternity Leave Coverage: PO Placement & Weekly Status Reporting PO Placement Partner with Planning to review quarterly/bi-annual/annual projections to ensure total quantities align with minimums Confirm MOQ, leadtime, ex-factory date, and PO drop date with the supplier to ensure all parties are confirming the same information Own weekly status reporting and sharing of information with cross functional partners Vendor & Cross-Functional Collaboration Ability to build and maintain strong relationships with international suppliers and manufacturing partners with support of vendor scorecards Comfort with establishing processes for vendor evaluations and audits to ensure compliance with Parachute's Vendor Code of Conduct (e.g., facility audits and certifications, value chain mapping, performance standards, etc.,) Process Improvement & Strategy Develop and implement production best practices that drive efficiency, reduce waste, and improve margins Establish and monitor KPIs related to on-time delivery, defect rates, and vendor performance, providing regular reports to leadership Partner with leadership to identify long-term opportunities for supply chain optimization and scalability After Maternity Leave Coverage wraps, integrate Quality Assurance into Production Management Define, implement, and maintain Parachute's quality standards across all product categories Manage third party inspections, and compliance processes to meet international quality and safety regulations Resolve quality issues quickly and effectively, ensuring minimal disruption to timelines and product flow Collaborate with vendors to proactively address quality concerns and implement corrective action plans Who You Are: Bachelor's degree in Supply Chain, Manufacturing, Textile Management, or related field. 6+ years of experience in production and quality management within home textiles, apparel, or consumer goods. Deep knowledge of textile manufacturing, fabric construction, finishing processes, and quality testing standards. Experience working with international vendors and factories. Strong analytical, problem-solving, and organizational skills. Excellent communication and negotiation abilities. Passion for sustainability, product excellence, and customer satisfaction. You Own the Outcome and show up with rigor, accountability and a bias for action. You Spring Forward and embrace everything with energy, adaptability, positivity and maturity. You Build the Best and are committed to growth, dreaming big, and sharing and receiving feedback in the spirit of always improving. What You'll Get: Free bedding for a great night's sleep, an awesome discount and $300 worth of free product a year! Health, dental and vision benefits with 100% employee coverage offering Flexible vacation packages 401k Competitive salary and stock options Parachute takes a market-based approach to pay, and pay may vary depending on your location. Your actual base salary will depend on factors such as your skills, qualifications, experience, and work location. The estimated pay range for this role is $95,000 - $120,000. About Us Parachute is a modern lifestyle brand focused on creating premium, responsibly-made home essentials. At Parachute we exist to fill homes with soft landings. Home is an extension of the self. It offers a sense of belonging and welcomes all with ease and warmth. It's where we recharge, wash off the day and rest up for tomorrow. Home is the most comforting word there is. That's why they say there's no place like it. The unmistakable feeling of home is what inspired us to create Parachute. To responsibly make essential, lasting items that transform a house into a home.Parachute was certified as a great place to work! Check us out here. Ensure your Parachute Home job offer is legitimate and don't fall victim to fraud. Parachute never seeks payment from job applicants. Parachute recruiters will only reach out to applicants from ********************* email address. For added security, where possible, apply through our company website at ***************************** .
$95k-120k yearly Auto-Apply 17d ago

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Updated December 12, 2025

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