Senior Quality Manager jobs at Orchid Orthopedic Solutions - 399 jobs

A leading public health organization is looking for a Director of Program Implementation in the Quality Improvement Department. This role involves managing a team to implement quality improvement initiatives, overseeing program goals related to cardiovascular health, and engaging with healthcare clients. The ideal candidate has supervisory experience, a background in clinical quality improvement, and project management expertise. This position offers a competitive salary and remote working options, promoting work-life harmonization. #J-18808-Ljbffr

A leading health organization is seeking a Director, Program Implementation to manage the Quality Improvement team in California. This role focuses on implementing quality initiatives, overseeing program goals across various health strategies including stroke and heart failure. Candidates should have at least three years of relevant experience and a Bachelor's degree. Competitive compensation is provided, with a salary range of $95,000.00 - $131,200. This position can be home-based, with a preference for regions in the western states. #J-18808-Ljbffr

The Director, Vendors and Partners Quality Management provides strategic and operational oversight of Rigel's external quality network, including global commercial partners and GxP vendors. This role ensures quality and compliance alignment with partners who hold Marketing Authorizations for Rigel's products outside the USA and drives quality and compliance with Rigel vendors supplying GxP materials or services. The Director is responsible for managing quality agreements, engaging in partner and vendor audits, and the exchange of quality documentation to support regulatory filings and inspections. Salary Range: $210,000 to $250,000 ESSENTIAL DUTIES AND RESPONSIBILITIES Establish, maintain, and manage Quality Agreements with partners and vendors to ensure clear GxP responsibilities. Lead the vendor quality management program through select-implement-manage-decommission lifecycle across GMP, GCP, and GLP areas. Manage partner complaint investigations and ensure compliant communication and documentation closure. Oversee vendor and partner audits, including scheduling, conduct, reporting, and follow-up actions. Coordinate exchange of quality documents with partners to support regulatory submissions and inspections. Lead Rigel Change Management program for clinical and commercial products, applying phase-appropriate and risk-based framework and ensuring compliance with regulatory requirements. Serve as a Quality lead for Rigel Technology Transfer projects. Provide Quality support for assessment and implementation of new assets. Develop and maintain metrics (KPIs) to monitor vendor and partner quality performance. Collaborate with Regulatory, Legal, and Supply Chain to ensure partners and vendors meet contractual and regulatory obligations. Provide QA input into business development and alliance management processes. Stay current with global regulatory expectations impacting partner and vendor oversight programs. Represent Rigel Quality in governance meetings with external partners and key suppliers. KNOWLEDGE AND SKILL REQUIREMENTS Bachelor's degree in life sciences or related discipline; advanced degree preferred. 12+ years of pharmaceutical Quality Assurance experience, including vendor and partner management. Strong understanding of global GxP regulations and supplier quality requirements. Experience leading audits and managing external Quality Agreements. Knowledge of both commercial and clinical product quality systems and regulatory submissions. Exceptional interpersonal skills for effective collaboration with external partners and cross-functional stakeholders. Ability to travel domestically and internationally for audits and partner meetings. WORKING CONDITIONS PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. #J-18808-Ljbffr

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. This is an on-site position based at our Foster City headquarters. *Prior Quality leadership and technical management experience in development and/or commercial programs.* Job Functions: Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for Pillar Lead, as needed, for meeting and decision making. Knowledge, Experience and Skills: In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product Basic Qualifications: 12+ years of relevant experience and a Bachelors degree in science or related fields; OR 10+ years of relevant experience and an advanced science degree such as MS, MD, OR 8+ years of relevant experience and a PharmD, PhD, in science or related fields OR 8+ years of relevant experience and advanced business degree such as an MBA Preferred Qualifications: 15+ years of relevant experience and a Bachelors degree in science or related fields; Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Prior Quality leadership and technical management experience in development and/or commercial programs. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. This is an on-site position based at our Foster City headquarters. *Prior Quality leadership and technical management experience in development and/or commercial programs.* Job Functions: Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for Pillar Lead, as needed, for meeting and decision making. Knowledge, Experience and Skills: In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product Basic Qualifications: 12+ years of relevant experience and a Bachelors degree in science or related fields; OR 10+ years of relevant experience and an advanced science degree such as MS, MD, OR 8+ years of relevant experience and a PharmD, PhD, in science or related fields OR 8+ years of relevant experience and advanced business degree such as an MBA Preferred Qualifications: 15+ years of relevant experience and a Bachelors degree in science or related fields; Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Prior Quality leadership and technical management experience in development and/or commercial programs. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R0045721 Full Time/Part Time Full-Time Job Level Director Remote Type Onsite Required Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr

A leading pharmaceuticals company based in San Francisco is seeking a Director of Vendor and Partners Quality Management. The role involves strategic oversight of quality compliance with external partners and vendors, managing quality agreements, and overseeing audits. The ideal candidate has over 12 years of experience in pharmaceutical Quality Assurance and must possess strong interpersonal skills for effective collaboration. This position requires a Bachelor's degree in life sciences, with an advanced degree preferred. #J-18808-Ljbffr

A global biopharmaceutical company is seeking a Director of Quality to lead R&D quality and compliance initiatives focused on electronic systems. The role involves executing the Quality strategy, adopting emerging technologies, and collaborating across departments to enhance operational excellence. The ideal candidate will have over 13 years of experience in the pharmaceutical industry, demonstrating strong leadership and a deep understanding of quality assurance methodologies. This full-time position is based in Foster City, California, offering a competitive salary range and comprehensive benefits. #J-18808-Ljbffr

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a Director, Quality Site Lead located in Foster City, CA. Job Functions Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic Gilead CXO partners/sites. Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key member of Business Review Meetings with CXO as Quality's voice for the contract organizations' oversight. Maybe member or backup member of Joint Steering Committee. Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed. Accountable for multiple external QA functions, including quality events, validation, and release/disposition. Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg CMC, to identify solutions and processes and align with key partners on implementation of new requirements; proactively address. Lead escalations for critical quality issues. Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives. Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements. Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required. Ensure GMP documentation is accurate and compliant with internal and external standards and requirements. Provide guidance to the business teams on regulatory requirements and assist where needed. Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs. Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion. Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan. Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations. May back up Pillar Lead, as needed. Champion Quality Risk Management, identifying key risks impacting CXO performance. Ensure PAI/PLI Readiness for assigned CXO sites. Up to 20% travel based on strategic plan. Manages a team of Quality Professionals. Knowledge, Experience and Skills Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation, cleanroom classification and qualification, new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operations, product release, disposition, and distribution. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Knowledgeable in Global requirement/standards for product registration and life cycle management of product quality. Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist. Excellent verbal, written, and interpersonal communication skills. Expert in prioritizing workload to address competing projects and timelines. Basic Qualifications 12+ years of relevant experience and a bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Prior experience leading, developing and managing people. Knowledge in technical and regulatory requirements pertaining to manufacturing, testing, product lifecycle management, and outsourced operations a must. Biopharmaceutical or Pharmaceutical experience a must. Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must. Significant experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred. Broad experience across several areas like CMO QA, Validation, Drug development experience, packaging/labeling and understanding of Parenteral, OSD, and Biologics. People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Job Requisition ID R0048129 Job Level Director #J-18808-Ljbffr

The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's R&D Quality Organization. This role is responsible for executing internal GVP audits, supporting E-System/Digital audits, as well as, support or lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross‑functional stakeholders, including R&D Quality Business Partners (QBPs), Inspection Management, Patient Safety, and other relevant departments. In partnership with GCP and E-System Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program. Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development and operational execution of the GVP audit function. Responsibilities include developing and improving audit tools and procedures, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high‑quality audits, supporting Gilead's mission to advance transformative therapies. ABOUT R&D QUALITY Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life‑saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do. We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life‑saving therapies to patients around the world? PRIMARY RESPONSIBILITIES GVP Audit Program Accountable for the successful oversight and completion of a broad spectrum of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes. Lead internal R&D quality audits for assigned R&D groups or locations. Provide subject matter expertise and support to project teams. Develop, drive, or support continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality mindset and culture. GVP Audit Operations Act as a primary point‑of‑contact to assigned R&D groups and advise on: GVP regulatory requirements, changing legislation, and relevant Gilead policies and procedures supporting audits and pharmacovigilance activities. Execute on the strategic audit plan. Plan, schedule, and conduct GVP audits in accordance with the audit plan. Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness. Collaborate with R&D Quality Business Partners and stakeholder SMEs. Support risk assessment activities, in partnership with risk program and SMEs. Support the overall inspection readiness of the GVP Audit program, including preparation for and participation in inspections. Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks. Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. Support the E‑Systems/Digital Audit program, as needed, ensure adherence to regulations and industry best practices, and maintain an external network to assure current understanding of industry trends. Quality Management Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements. Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements. Stay current with evolving global PV regulations and guidance. Support the development of GVP Audit material/insights for quality forums and management reviews. Training & Development Develop and deliver on GVP training for assigned R&D groups, ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence. Establish relationships with key stakeholders, including contract auditors, cross‑functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives. BASIC QUALIFICATIONS PharmD/PhD with 2+ years of relevant experience MA/MS/MBA with 8+ years of relevant experience BA/BS with 10+ years of relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields. PREFERRED QUALIFICATIONS U.S. Education & Experience BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field. Extensive experience leading GVP audits, in the biopharma or related industry. Proficiency in pharmacovigilance regulatory requirements (Global) is a must. Expert‑level experience working with GVP processes and systems is required. Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. Broad experience participating in cross‑functional projects and teams with responsibilities related to pharmacovigilance and quality system activities. Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs. Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred. Certification as a Quality Auditor is preferred. Knowledge & Other Preferred Requirements Expert knowledge of the drug development process and GVP, including global regulations (FDA, EMA, ICH) and their application to cross‑functional drug development. Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GVP. Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision‑making track record. Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross‑functional partnering, and key contributions to strategy, operational and infrastructure development. Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio. Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance. Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function. Demonstrates ability to integrate varied concepts and data to develop relevant solutions. Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions. Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. Strong critical and strategic thinking skill and risk‑based mindset. Proven track record of successful change management implementation across highly matrixed organizations. Ability to travel (up to 30%) People leader accountabilities Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission‑driven bio‑pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible #J-18808-Ljbffr

A leading biopharmaceutical company in California is looking for a seasoned Quality Lead to define and execute the quality strategy for Development Electronic Systems, focusing on the integration of emerging technologies like AI. The ideal candidate should possess over 13 years in the pharmaceutical industry, demonstrating exceptional leadership and problem-solving capabilities. This role emphasizes cross-functional collaboration, risk management, and fostering a culture of continuous improvement while ensuring compliance with regulatory standards. #J-18808-Ljbffr

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life‑threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Analytical Lifecycle Management: The Director Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include managing Clinical specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role is accountable for monitoring QC test method execution and leading the analytical lifecycle management of Clinical biologics drug substances and drug products. The Director collaborates with cross‑functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and regulatory compliance. Department: Global Quality Control - GQC‑Biologics Job Responsibilities: Oversee the development and implementation of end‑to‑end Specification strategy for Gilead's portfolio of biologics products. Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead. Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met. Provide oversight and management of Biologics Reference Standards and Critical Reagents. Demonstrate a clear understanding of biological product testing methods and assays for effective QC test method execution, troubleshooting, and remediation of atypical results. Identify, select, manage, and evaluate CMOs/CTLs, consultants etc. to control quality in support of achieving PDM's strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor analytical method performance. Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across external network partners. Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control. Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs. Lead the Compendial Review Program, leveraging existing Gilead Quality Control Systems. Lead or serve as a key project team member on large cross‑functional projects, often with high visibility to senior management within the organization or with international impact. Provide a long‑term view to senior QC Leadership based on personal knowledge of the competitive environment. Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GxP. Willing to support future laboratory work. Willing to support Commercial QC team. Qualifications: 12 + Years' experiences with BS OR 10 + Years with MS OR 8+ Years with PhD in Chemistry, Biochemistry or related field. 2 + year o f relevant experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation. Must have experience with GMP systems ( e.g. LIMS, QMS, SAP) and software such as Empower, JMP, Discoverant . Preferred experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. #J-18808-Ljbffr

A biopharmaceutical company in Foster City seeks a Director of Quality Control Biologics to provide strategic leadership and oversee quality assurance operations. The role encompasses managing specifications and ensuring compliance with GMP standards. The ideal candidate has extensive experience in analytical lifecycle management and quality control, along with strong leadership and communication skills. This position plays a critical role in advancing innovative medicines to treat life-threatening diseases. #J-18808-Ljbffr

A leading biotechnology firm located in California is seeking a Director of Quality Assurance to oversee product quality and establish specifications for clinical and commercial products. The role requires extensive experience in analytical chemistry and regulatory compliance, along with strong leadership skills in a complex matrix environment. This is a full-time on-site position offering the opportunity to lead strategic quality initiatives. #J-18808-Ljbffr

The primary responsibility for this position is to establish phase appropriate product specifications for Gilead's clinical and commercial products. In addition, this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s). The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. Job Functions Expert in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical leadership and ownership. Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product (process development, CQA analysis, stability, comparability, etc). Ability to evaluate Global product filing strategies with core PDM Team for implementation. Provide timely support for health authority interactions on the product, authorship/review (as needed) relevant health authority information requests for in-process controls, process development (comparability), method validation, specifications, reference standard, and stability sections of regulatory submissions. Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities. Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making. Knowledge, Experience and Skills Well verse in technical requirements for product control systems. Strong knowledge and practical experience in analytical chemistry, including separation science, wet chemistry, physicochemical characterization or related areas. Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Basic Qualifications 12+ years of relevant experience and a Bachelor's degree in science or related fields. OR 10+ years of relevant experience and a science degree MS OR 8+ years PhD Preferred Qualifications Prior Quality leadership and technical management experience in development and/or commercial programs. 15+ years of relevant experience and a Bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, PharmD, PhD or an advanced business degree such as an MBA. Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Broad experience across several including process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics. Job Requisition ID R0047720 Full Time/Part Time Full-Time Job Level Director Remote Type Onsite Required #J-18808-Ljbffr

A leading biopharmaceutical company in California is seeking a Senior Director for Global Supplier Quality. The successful candidate will lead a team of Quality Professionals, ensuring compliance with GMP standards while managing supplier quality initiatives. This role requires extensive experience in biopharmaceutical management, exceptional leadership skills, and a strong understanding of regulatory requirements. Candidates should have a solid educational background in science and proven leadership experience in complex organizations. Competitive salary & benefits are offered. #J-18808-Ljbffr

The CQM Supervisor oversees non-clinical auditors in the Clinical Quality Management (CQM) department, ensuring regulatory compliance and the quality of processes in daily Non-Clinical Utilization Management (UM) activities, under the direction of a manager. This Supervisor is responsible for conducting live audits of UM case files, assigning drivers and presenters, and ensuring their performance is appropriate. The role also involves monitoring UM system controls and processes, specifically those that do not require clinical decisions. A solid understanding of comprehensive regulations, UM policies and procedures, the UM system, UM auditing, and quality improvement is essential for this position. Essential Duties and Responsibilities: - Familiarity with Non-Clinical UM regulations, processes, and systems. - Ability to assign workloads effectively while managing staff. - Proficient in presenting case files and conducting interviews regarding non-clinical questions. - Skilled in designing audit tools to monitor Non-Clinical UM processes completed by non-clinical staff. - Strong communication skills for effective interaction with internal clients and external customers. - Capable of training employees using Policies & Procedures (P&Ps) and audit tools. - Provide constructive feedback and exhibit strong active communication skills. - Summarize quality monitoring findings, analyze root causes, and propose quality improvement plans. - Suggest and design focused audits that help improve compliance in Non-Clinical UM processes. - Request decision support for creating and enhancing Non-Clinical UM monitoring reports based on changes to UM P&Ps. - Ensure auditors complete audits and necessary remediation within specified timeframes. - Collaborate with the Non-Clinical UM team to ensure monitored focus areas are addressed and that process quality is tracked. - Work with operational teams to evaluate the effectiveness and efficiency of process changes made for quality improvement. - Ensure that new processes are accurately implemented through reports and case file reviews. - Report issues identified to the Prior Authorization Compliance Director based on findings. - Review updated policies and procedures, and be able to update the quality monitoring tool accordingly. - Maintain all evidence related to quality monitoring projects. - Track and manage daily reports received from the decision support team. - Report any issues related to internal processes (e.g., timeliness) to the CQM manager. - Attend department meetings, in-house services, and trainings, completing acknowledgments within the required timeframe. - Perform all other duties as directed by management. Education and Experience: - Three to five (3-5) years of experience in non-clinical utilization management. - Preferred: at least two (2) years of experience in non-clinical UM supervision or auditing. - Proficiency in MS Office programs (Word, Excel, Outlook, Access, PowerPoint). - Typing speed of 60 words per minute with accuracy. - Ability to handle confidential matters responsibly. - Strong analytical, creative problem-solving, and organizational skills. - Capacity to work in a multi-tasking, high-stress environment. - Effective strategy execution within timelines, delivering quality results. - Ability to adapt and thrive in a fast-paced environment, demonstrating proactivity. - Capable of managing multiple projects simultaneously, adjusting priorities daily, and knowing when to seek assistance with conflicting priorities. - Self-motivated, assertive, ambitious, and possessing high personal ethics. - Ability to collaborate with all levels of management and establish positive working relationships across various divisions in the company. Compensation: The pay range for this position at the start of employment is expected to be between $70,304 and $72,000 annually, depending on experience. However, the base pay offered may vary based on multiple individual factors, including market location, job-related knowledge, licensure, skills, and overall experience. The total compensation package for this position may also include other elements, such as a sign-on bonus and discretionary awards, along with a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), depending on the position offered. Details regarding participation in these benefit plans will be provided to employees who receive an employment offer. If hired, the employee will be in an “at-will position,” and the company reserves the right to modify base salary (along with any other discretionary payments or compensation programs) at any time, including for reasons related to individual performance, overall company performance, or market factors. As one of the fastest-growing Independent Physician Associations in Southern California, Regal Medical Group, Lakeside Community Healthcare, and Affiliated Doctors of Orange County offer a dynamic and fast-paced work environment. Employer will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the LA City Fair Chance Initiative for Hiring Ordinance.

**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.

Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

**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.** **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 (******************************************** **Pay Range** $57.37 - $85.33 /hour We are an equal opportunity/affirmative action employer.

**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.