Director of Nursing Quality | NYC
Quality manager job in New York, NY
A mission-driven safety-net health system serving one of NYC's most vibrant communities is seeking a Director of Nursing Quality - a leader who knows how to turn Quality and CQI principles into meaningful improvements that nurses actually feel at the bedside.
What You'll Do:
Lead system-wide Quality and CQI initiatives, support nurse managers, guide Joint Commission and DOH readiness, and strengthen the culture of patient safety. You'll translate data into real-world practice and foster collaboration across departments.
What You Bring:
✔ NYS RN, BSN + Master's
✔ 3+ years of leadership experience
✔ Strong grounding in Quality, policy development, and data-driven change
✔ Ability to resolve escalated issues with calm, clarity, and cross-team collaboration
✔ CPHQ/CPHRM preferred
This is a high-impact leadership role in a community that values equitable, high-quality care - and the nursing leaders who make it possible.
To explore this confidentially, schedule here:
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Thanks!
James Weston, Managing Partner
Polaris Placement, LLC
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Making connections that make all the difference.
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Director of Quality Improvement
Quality manager job in Yonkers, NY
Under the direction of the Vice President and Chief Quality Officer, the Director of Quality Improvement is responsible for developing and implementing the organization's Performance Improvement plan and priorities consistent with regulatory standards and evidence based best practices. As a member of the leadership team, serves as a role model and leader to colleagues and staff throughout the organization. Thoughtfully develops and implements initiatives to achieve improvements consistent with hospital strategic priorities. Promotes a culture that is positive, that values individual strengths, and is committed to optimal patient care, and compliance with regulatory standards. This position is responsible for direct supervision of the Quality Analyst and Quality Improvement Specialist and serves as the Stroke Coordinator.
Key responsibilities include:
• Strategic focus on improving quality. Responsible for goal setting and achievement using SJMC established Performance Improvement methodology and analytic tools. Defines measurable and actionable metrics and ongoing monitors to sustain performance.
• Identifies and drives analytic needs for improvement projects/initiatives. Supports leaders in development of problem charter and selection of the best tools for data analysis. Mastery of basic statistical concepts, tools and techniques and working knowledge of improvement tools and techniques. Teaches/mentors others on basic topics and able to assist others with advanced topics.
• Serves as Stroke Coordinator and supports the Stroke Program including defining and developing structure, process and outcome measures, policies, accreditation and facilitating and actively developing initiatives to meet and exceed evidence-based care metrics for stroke patients.
• Lead and/or facilitate complex multidisciplinary improvement teams as needed to achieve quality and performance improvement goals.
• Responsible for oversight of data collection, measurement, and data analysis for organizational, federal and state quality metrics.
• Coordinate mortality, patient complaint, and outcome reviews.
• Serve as a regulatory resource regarding state and federal regulations and standards, including but not limited to CMS, TJC, and NYS.
• Create and present data needed for evaluation and appropriate action by committees, leadership, and quality improvement teams.
• Represents the organization within and external to the community when required.
• Assist in improving patient experience through analysis of data and implementation of initiatives to improve performance.
Requirements:
• Bachelor's Degree or commensurate experience required.
• Registered Nurse in New York State required
• Master's Degree in Healthcare specialty preferred
• Current certification as CPHQ strongly preferred. Certification required within 3 years of hire date.
• Previous managerial experience preferred.
• Competence in Microsoft office products including PowerPoint and Microsoft Excel.
• Familiarity with health care clinical operations and processes in an acute care hospital setting.
• Familiarity with regulatory requirements as related to hospital setting.
Other Requirements:
• The employee must regularly lift, carry or push/pull less than 10 pounds, frequently lift, carry or push/pull less than 10 pounds, and occasionally lift, carry or push/pull up to 10 pounds.
• While performing the duties of this Job, the employee is regularly required to perform activities that require fine motor skills. The employee is frequently required to do repetitive motion, hear, reach, sit, and speak. The employee is occasionally required to walk.
• Specific vision abilities required by this job include color vision, far vision, and near vision.
• The noise level in the work environment is usually quiet.
Salary: $170K-$180K
Saint Joseph's Medical Center is an equal opportunity employer.
Director, Capital Budget and Contract Control (Design and Construction)
Quality manager job in New York, NY
Work Shifts
9:00 A.M - 5:00 P.M
Duties & Responsibilities
Under the direction of the Budget Director (Corporate), compiles, administers and obtains approvals of the Capital Facilities Budget; evaluates project proposals, monitors and reports regularly on project status; maintains Corporation records of funds, contracts and cash outlays. Develops, recommends and implements criteria and procedures to improve the effectiveness of the Corporation's facilities improvement programs.
Examples of Typical Tasks
Directs annual budget cycles which include receipt and program and fiscal analysis of capital requests and Article 28 applications from health care facilities. Evaluates requests and makes recommendations to Director of Planning for funding and work orders.
Obtains approvals of Capital Budget, Programs and Contracts from the City, Board of Estimate, Financial Control Board, HSA and State Health Department.
Generates project cost data and establishes criteria procedures necessary to maintain a sound investment strategy and to sustain effective participation by the hospitals, community boards and regulatory and financing agencies in our facilities improvement programs.
Monitors and reports regularly on Capital project status to the Corporation and the City of New York using a computerized Management Information System.
Maintains records of capital funds, expenditures and cash outlays. Certifies capital funding for expenditures and estimates costs for fixed asset accounting and reimbursement reporting.
Interfaces with City Comptroller and land and construction agency records to establish costs of construction, debt management and related services furnished by the City for Corporation purposes and maintains separate records of these cost auditable to City source records.
Assists in audits of financial records as required by the Corporation, the City Comptroller, City Construction Board, State Emergency Financial Control Board and reimbursement agencies.
Prepares forecasts of fund and cash requirements and requisitions cash from the City Capital Project Fund.
Administers an employee time recording and billing system to record time and cost of staff design and construction services for each capital project and vouchers and receives cash from the city Capital Project Fund for staff services provided under interfund agreements.
Administers contract change control requirements.
Evaluates purchase and contract regulations, procedures and standard contracts and certifies purchase and receipt of all major equipment and permanently identifies the piece and record data in the major equipment inventory control system.
Develops procedures with criteria for Prequalification of Contractors as provided in Section 8 of the Corporation Act. Solicits, evaluates and communicates prequalification status to all contractors maintaining lists and individual contractor financial and experience records.
Serves as a member of the Architectural and Engineering Selection Board.
Supervises and directs the staff assigned to assist in the performance of these major duties and evaluates employee performance.
Minimum Qualifications
1. A Masters Degree in Business Administration, Science, Health Care Administration, Engineering or related discipline from an accredited college or university or a license as a Professional Engineer or registration as an Architect; and,
2. Eight years managerial experience in Capital Program or budget work in the construction field including four years experience in budget administration and management of health care facilities; or,
3. A satisfactory equivalent combination of education, training and experience.
Department Preferences
Preference will be given to qualified candidates with the following knowledge, abilities, education, experience and/or skills:
EDUCATION:
A Master's degree from an accredited college or university in Hospital Administration, Health Care Planning, Business Administration, Public Administration or an approved related program.
LICENSE:
A New York State license as a professional engineer or registered architect or a license as a professional engineer or registered architect from a state that has reciprocity with New York State may be substituted for the four years of education and experience.
EXPERIENCE:
At least 10 years of related experience in design and/or construction management with experience in healthcare clinics; or as a journeyperson in one or more of the skilled building construction trades.
Full-time satisfactory experience in planning, design and program development pertaining to meeting health needs, health care planning, design and program implementation, with at least three years of responsible level administrative experience coordinating the planning, design, and construction and commissioning.
KNOWLEDGE IN:
Thorough knowledge of the principles, practices and methods of Healthcare and Space Management.
Long Term Capital Planning
Design Management, Construction Management, Budget Management and Time Management
Negotiations
Regulatory (DOB, FDNY, DOH) Close outs
SKILLS:
Excellent verbal / written skills.
Excellent technical, conceptual, and financial skills.
Motivate team efforts to accomplish goals.
COMPUTER PROGRAMS/SOFTWARE OPERATED:
Microsoft Word and Excel (required)
Microsoft Access,
MS Project
Auto CADD/Revit.
Procore/E-builder or similar
Repair Quality Engineer
Quality manager job in Englewood, NJ
Hanwha Vision America (HVA) is an affiliate of the Hanwha Group, a Fortune Global 500 company. HVA is an industry-leading provider of advanced network video surveillance products, including IP cameras, storage devices, and video management systems, founded on world-class technologies. We offer end-to-end security solutions and have achieved global success across a wide range of industry verticals, including retail, transportation, education, banking, healthcare, hospitality, and airports.
Hanwha Vision America (HVA) is seeking a Repair/ Quality Engineer to support HTCC's engineering and repair operations by performing intake screening, basic diagnostics, quality checks, and documentation.
The role ensures that incoming units are properly evaluated, repair processes run efficiently, and completed products meet quality standards before shipment. This position combines repair-support responsibilities with quality assurance activities to improve workflow efficiency, accuracy, and overall service performance.
Major Functions / Accountabilities
Perform initial screening and basic functional checks on incoming units
Identify obvious issues or simple conditions that can be resolved before repair
Support repair workflow by preparing units, organizing information, and performing basic diagnostics
Conduct quality checks on completed repair units to ensure they meet internal standards
Document inspection results and update system records accurately
Assist with failure analysis for repeated issues and provide feedback to engineering
Inspect packaging quality and verify final shipment readiness
Collaborate with repair staff, engineering, logistics, and warehouse teams as needed
Maintain checklists, guidelines, and standard procedures for inspection work
Support process improvements related to efficiency, quality, and documentation compliance
Knowledge, Skills & Requirements
Preferred background: Electronics, Electrical Engineering, Computer Engineering, or related field
Basic understanding of electronic components (e.g., resistors, capacitors, diodes)
Ability to use multimeters and basic diagnostic tools
Strong attention to detail and problem-solving skills
Ability to follow technical checklists and standardized procedures
Proficiency with Microsoft Office and basic system data entry
Bilingual (Korean/English) preferred but not required
QA Director
Quality manager job in New York, NY
Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing)
• Excellent understanding of QA metrics, entry/exit criteria
• Experience in Insurance or Financial services industry sector will be good to have
Roles & Responsibilities
• Formulate Software Quality Assurance strategy (QA and UAT)
• Establish quality standards
• Establish quality documentation by writing and updating quality assurance procedures
• Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures
• Review all the program testing deliverables across Software Testing Life Cycle (STLC)
• Ensure testing deliverables completeness on test scope coverage
• Ensure program testing schedule is realistic
•Ensure traceability on program requirement to test cases & result
• Perform root cause analysis and create pattern to identify frequently occurring defects
• Arrange review finding walk-through sessions, publish detail review findings
• Provide corrective actions/recommendations/best practices in reducing defect trend
• Track closure of review findings and implementation of actions/recommendations
• Ensure program testing risks and assumptions are clearly articulated
• Create and publish program quality dashboard
Thanks & Regards,
Additional Information
If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number.
Full Name:
Email:
Skype id:
Contact Nos.:
Current Location:
Open to relocate:
Start Availability:
Work Permit:
Flexible time for INTERVIEW:
Current Company:
Current Rate:
Expected Rate:
Total IT Experience [Years]:
Total US Experience [Years]:
Key Skill Set:
Best time to call:
2 Slots for phone interview:
In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested.
All your information will be kept confidential according to EEO guidelines.
Food Safety Quality Assurance Manager
Quality manager job in Carlstadt, NJ
& Sons Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing.
Summary:
This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation.
Essential Job Functions:
Food Safety / Regulatory
* Managing implementation of the HACCP Plan, its associated documents and including reassessments
* Maintaining records in accordance to the policy / HACCP program
* Conduct plant GMP inspections and monitor GMP's for compliance
* Responsible for maintaining the company's compliance with FSIS regulations.
* Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products.
* Oversee training program for GMP's, HACCP and Food Defense/Food Fraud.
* Respond to non-compliance reports issued by FSIS.
* Manage the 3rd party Sanitation program for the facility.
Quality / Customer Service
* Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's.
* Strive for continuous improvements of products, process, procedures, and reliability.
* Maintain data of customer requirements, quality specifications and reporting requirements.
* Manage quality training program.
* Ensure specification compliance for raw materials and finished products.
* Managing implementation of quality programs.
* Assist with product development and special projects associated with product development.
* Respond to customer complaints with CAPA's / letters as needed.
* Establish the raw material and finished product shelf life.
Other
* Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor
* Manage the department to meet budget.
* Other tasks and projects may be assigned.
* 10 - 20% travel required
Minimum Requirements:
* Red Meat Experience a Must
* Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred.
* 5 plus years' experience working in the Food Industry in a leadership role.
* HACCP Knowledge and Experience
* SQF / BRC Knowledge and Experience
* Ability to think independently and take responsibility for decisions.
What We Offer
* The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process.
* Time Off: PTO, Safe & Sick Time, and Paid Holidays.
* Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits.
* Financial Benefits: 401(k) + employer match and life insurance.
* Location: This is an on-site role located in Carlstadt, NJ.
* Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.
Director, Clinical Quality Assurance
Quality manager job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
· Independently conduct audits
· Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
· Facilitate Sponsor health authority inspections of global clinical facilities and study sites
· Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
· Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
· May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
· Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
· 5+ years of experience in GCP auditing.
· Substantial experience in inspection management.
· Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
· Demonstrated ability to operate and influence decision-making processes
· Effective communication skills
· Successful track record of supervising employees and managing cross-cultural differences
· Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
· Knowledge of data integrity controls and systems quality for clinical area
· Strong analytical skills and report writing skills
· Experience with GxP systems including computer system validation and associated regulations, recommended.
· Ability to Travel (approximately 20%)
·
Candidates near Eisai's NJ/PA location will be preferred.
For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyDirector of Quality Assurance
Quality manager job in New York, NY
Meet Our Team:
The Senior Director Finance role is an exciting opportunity to be a key leader serving as a member of the India Leadership team and Global Finance team supporting a dynamic and high growth organization. This is a multi-faceted role handling a large team working in a highly matrixed-structure. Picture Yourself at Pega: In this role you will establish strong processes and controls that enable the group to deliver high quality results. The position not only has the responsibility of looking inward, but also to keep an eye outwards and apprise the business and key stakeholders of any threats and opportunities arising out of any economic, political or any other changes in India/APAC. What You'll Do at Pega:• Manage the APAC financial closing process - work cross-functionally and coordinate everyone's efforts to ensure that all required financial data is properly captured, reconciled, documented, and disclosed.• Ensure that all APAC financial data is in compliance with Generally Accepted Accounting Principles (GAAP).• Ensure that monthly close deadlines for US SEC reporting purposes are met.• Develop and maintain accounting policies and procedures including process documentation and control matrices.• Review and approve APAC accounting transactions; responsible for overseeing APAC general ledger, sub-ledgers and fiscal records.• Manage the fixed asset systems.• Manage APAC operating cash, the weekly bank reconciliation, and reporting.• Direct and coordinate financial planning and budget management functions• Recommend benchmarks for measuring the financial and operating performance• Monitor and analyze monthly operating results against budget• Oversee daily operations of the finance and accounting department Who You Are: A highly proficient senior leader who can inspire, build, and retain a highly engaged, efficient and motivated team. Has strong analytical and project management skills to be able to allocate resources well and influence, build consensus, and resolve conflicts as required. Support a team-oriented environment, ensuring that all tasks are being completed timely and accurately. What You've Accomplished:• CA (Chartered Accountant) with strong experience in working within the technology industry• 15+ years' experience across finance, accounting, budgeting, and cost control principles including U.S. and India Generally Accepted Accounting Principles• Knowledge of automated financial and accounting reporting systems.• Knowledge of federal and state financial regulations• Ability to analyze financial data and prepare financial reports, statements and projections• Small and large project/program orientation• Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects. Pega Offers You:• A rapidly growing yet well-established business• The world's most innovative organizations as reference-able clients• Analyst acclaimed technology leadership in a massive emerging market• A workplace that requires people to have an informed opinion
Auto-ApplyDirector, Head of FCC Quality Assurance
Quality manager job in New York, NY
Job Description
Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness.
Key Responsibilities:
Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy.
Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews.
Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth.
Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units.
Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly.
Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices.
Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation.
Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators.
Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability.
Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement.
Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed.
Qualifications:
Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry.
Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings.
Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies.
Strong working knowledge of BSA/AML/OFAC requirements.
Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives.
Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions.
Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations.
Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology.
Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred.
Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role.
Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable.
Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred.
Salary: $180,000 - $210,000 K / year
"Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience."
About Community Federal Savings Bank (CFSB)
Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing.
We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.
Director, Quality Assurance
Quality manager job in New York, NY
Job Description
Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development.
General Summary of Duties:
The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products.
A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player.
Specific Duties, may include but not be limited to the following:
· Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance
· Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.
· Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance.
· Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding
· Work on qualification and validation plans, assure proper batch releases and disposition.
· Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA)
· Provide quality input on contracts and serve as a point person for negotiations of quality agreements.
· Champion a culture of quality and continuous improvement across manufacturing and development operations.
Desired Skills and Qualifications
· Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry
· Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements
· Demonstrated hands on experience working on complex projects.
· In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
· Strong partnering and communication skills required, as well as project management skills.
· Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.
· Ability to work effectively in a collaborative, fast-paced environment.
Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits.
Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available.
Physical Demands/ Working Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.
While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.
Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.
Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.
Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.
Director: Ambulatory Care Quality Assurance
Quality manager job in New York, NY
Under the direction of the Vice President, the Director of Ambulatory Care Quality plans, implements, and directs quality improvement and patient experience initiatives across all SBH Ambulatory Care sites. The Director is responsible for developing and managing action plans to improve performance on quality metrics, maintain regulatory compliance, and enhance the patient experience.
The position leads the governance and facilitation of the Ambulatory Quality Committee and the Ambulatory Patient Experience Workgroup. The role oversees performance improvement projects, chart audits, documentation reviews, and new workflow implementations to enhance outcomes and patient-centered care. The director also assists the VP with departmental compliance programs and reviews.
Responsibilities:
Provides leadership to the Ambulatory Care Quality & Population Health department, supporting the VP with department strategy, operations and management.
Prepares and facilitates the Ambulatory Quality Committee, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans.
Prepares and facilitates the Ambulatory Patient Experience Workgroup, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans.
Designs and implements quality assurance and performance improvement (QAPI) initiatives to improve patient care, advance population health, and drive value-based care outcomes.
Supports Ambulatory Care Directors and leaders to implement QAPI initiatives in their own areas, and to develop QAPI reports and Performance Improvement posters.
Develops training content and performance feedback tools to coach ambulatory providers and staff on quality improvement best practices.
Leads internal audit processes, regulatory survey readiness (e.g., Joint Commission, NCQA, NYS DOH), and documentation compliance reviews.
Assists the VP with departmental compliance programs and reviews including chart and billing audits, and investigations.
Performs other related duties at the discretion of the Vice President.
Attends scheduled department and division meetings and participates as appropriate.
Behavioral Health Regulatory and Quality Manager
Quality manager job in New York, NY
Who We Are: St. John's Episcopal Hospital is the only hospital providing emergency and ambulatory care to the densely populated, culturally and economically diverse, and medically underserved populations of the Rockaways and Five Towns in southern Queens County and southwestern Nassau County, New York. Celebrating over 110 years of community care, the 257-bed facility provides people of all faiths with comprehensive preventive, diagnostic treatment and rehabilitative services, regardless of ability to pay.
Come Grow With Us!
Type: Full-Time
Shift: Days
Hours: 8:00AM - 4:30PM
Pay: $115,000. - $130,00.00
Responsibilities:
* Responsible for supporting the development and management of quality programs and initiatives across behavioral health programs
* Investigate and complete RCA for all NYSOMH/Justice Center reportable events for both inpatient and outpatient behavioral health in collaboration with Risk Management Department
* Collaborate with leadership to ensure all corrective actions are completed.
* Work with the leadership team to achieve full regulatory compliance including TJC, OMH and CMS.
* Collaborate with hospital quality initiatives to ensure alignment for the behavioral health areas with the organization's strategic priorities.
* Responsible for all data collection, working with Information Technology to ensure data is collected timely and accurately.
* Implements routine, standardized audits of medical record documentation, environment of care, and other audits as required for inpatient behavioral health and emergency department behavioral health with the goal of facilitating standards compliance, quality of care monitoring and problem identification.
* Supports Behavioral Health Leadership in monitoring Hospital Based Inpatient Psychiatric Services (HBIPS) Core Measures, develops performance improvement plans, and education to drive improvement.
* Drive sustainable quality improvement strategies and projects, working with leadership, team members and patients /families to identify priority areas and improve outcomes.
* Project lead on all NYS OMH collaborative projects such as "Zero Suicide" & "PSYCKES".Assess areas for risk potential, completing proactive risk assessments.
* Complete all treatment over objection for the inpatient behavioral health units.
* Assist in departmental performance improvement activities & projects as assigned by supervisor.
Requirements:
* Master Degree in social work, psychology, mental health counseling, nursing and applicable NYS license
* Three years experience in medical record review, regulatory incident management and reporting, quality data analysis, performance improvement activities and survey readiness working within behavioral health departments in licensed inpatient and/or outpatient treatment settings is required.
SAP Quality Management/Manufacturing Manager - Chemicals Industry
Quality manager job in Morristown, NJ
We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational.
As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement
You Are:
Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction?
Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world
You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds.
Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them.
The Work:
Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to:
* Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future)
* Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations
* Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions
* Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation.
* Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture
* Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise
* Be a thought leader, build assets and best practices and develop the next level of transformation experts
Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements
Qualification
Here's what you need:
* Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing.
* Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement)
* Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients
* Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area
* Prior experience in a Consulting and/or Advisory role
* Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here.
Role Location Annual Salary Range
California $94,400 to $293,800
Cleveland $87,400 to $235,000
Colorado $94,400 to $253,800
District of Columbia $100,500 to $270,300
Illinois $87,400 to $253,800
Maryland $94,400 to $253,800
Massachusetts $94,400 to $270,300
Minnesota $94,400 to $253,800
New York/New Jersey $87,400 to $293,800
Washington $100,500 to $270,300
Locations
Quality Manager - Food Manufacturing
Quality manager job in New York, NY
Job DescriptionJob Title: Quality Manager - Food Manufacturing
About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes.
Key Responsibilities:
Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing.
Oversee the quality control processes to ensure compliance with industry standards and food safety regulations.
Collaborate with cross-functional teams to identify and resolve quality issues.
Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements.
Analyze data and reports to identify areas for improvement and implement corrective actions.
Lead and mentor the quality assurance team to achieve departmental goals.
Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain.
Qualifications:
Bachelor's degree in Food Science, Quality Management, Engineering, or a related field.
Proven experience as a Quality Manager or similar role in the food manufacturing industry.
Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000).
Excellent analytical and problem-solving skills.
Strong leadership and communication abilities.
Experience with quality management software and tools.
Attention to detail and a commitment to excellence.
Preferred Skills:
Certification in quality management or food safety (e.g., Six Sigma, CQE).
Familiarity with regulatory requirements relevant to the food industry.
Director of Quality Assurance and Training
Quality manager job in New York, NY
The Director of Quality Assurance & Training ensures appropriate and effective monitoring of existing procedures of program operations and delivery of services. The position also maintains an ongoing staff training program to ensure that staff are up to date on policies, procedures, and enhanced service practices.
What You'll Do
Create SOPs and Desk Guides for new and existing programs, reviewing and updating materials for programs and conducting training with staff to ensure understanding and compliance with both funder and Fedcap requirements.
Develop and maintain an annual report that provides a thorough description of Fedcap's Quality Assurance activities with an established Quality Improvement Plan (QIP) model.
Develop and implement quality assurance tools to measure and assess the impact of systems, policies and protocols on operational efficiencies and program effectiveness.
Conduct site visits to observe staff interaction with participants including intakes, service plan creation, and workshops.
Review case files for completeness, accuracy, and compliance.
Monitor Customer Service standards including conducting participant focus groups and analyzing surveys to gather feedback and increase awareness of participants' perspective of program services.
Prepare monthly and quarterly reports for Senior Leadership and regulatory bodies.
Identify gaps in program and staff performance and designing and conducting staff training to cure deficiencies and reiterate company standards.
Develop and conduct training programs to provide to WeCARE operations staff on various policies, procedures, and best practices.
Research and continuously update training modules on various topics relevant to providing the best possible services to WeCARE participants.
Assist with external audits conducted by funders and third-party auditors.
Conduct safety and risk assessment to ensure compliance with ADA and regulatory standards at service locations.
Work collaboratively with program departments, external agencies and stakeholders to support compliance efforts and monitor remediation (Corrective Action) activities.
You're a great fit for this role if you have:
A bachelor's degree in public health, public administration, human services, or a related field, with master's degree preferred.
At least 2 years' experience in quality assurance, preferably in social services, public health, or workforce development.
Experience with workforce development is a plus.
Compensation
$120,000-$130,000
The Fedcap Group
provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. We are an EEO employer committed to diversity, M/F/D/V.
Auto-ApplyQuality Manager - Supplier ODA Focal
Quality manager job in Plainfield, NJ
Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description
Key Accountabilities:
•Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives.
•Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication.
•Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives.
•Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions.
•Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements.
•Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety.
•Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence.
•Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates.
•Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions.
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies
Qualifications:
Minimum Requirements:
This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies.
When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control.
•Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control.
•ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance.
•3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry.
•Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC.
•Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills.
•Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment.
Preferred Requirements:
•ASQ certification
•ISO Lead Assessor Certification
•5 years plus Quality Assurance/Control
•3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience).
•Training in strategic planning and motivation
Benefits Overview
We offer competitive company benefits to eligible positions, such as :
Medical, Dental, Vision Insurance
Life Insurance and Disability
Voluntary Wellness Programs
401(k) and RRSP programs with Company Match
Paid Vacation and Holidays
Tuition Reimbursement
And more!
Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information.
Disclaimer
This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information.
TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers.
TK does not:
1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.;
2. Request payment of any kind from prospective jobseekers or candidates for employment;
3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK;
4. Send checks to job seekers; or
5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties.
PLEASE NOTE:
1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner;
2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK;
3. Anyone making an employment offer in return for money is not authorized by TK; and
4. TK reserves the right to take legal action, including criminal action, against such individuals/entities.
TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. Please visit our official careers website at ******************************** to view authentic job openings at TK.
If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************.
We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.
Auto-ApplyQuality Control Manager
Quality manager job in Saddle Brook, NJ
Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to:
Leading, hiring, developing, training, and evaluating QC personnel
Devising sound hiring strategies based on business needs
Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials
Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance
Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies
Assuring alignment and efficient continuity in laboratory practices between sites
Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records
Ensuring completion of all client QC requirements related to GMP cellular products and/or materials
Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable
Prioritizing, scheduling, and managing multiple projects and resources simultaneously
Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings
Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function
Delegating maintenance, tracking, and trending aspects of the deviation reporting system
Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing
Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable
Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation
Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities
Participating in and tracking group budget setting and cost containment drives
Communicating and maintaining trust relationships with senior management, business partners, and clients
Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times
Completing projects and special tasks as assigned by the Global Quality Head
Off-schedule shifts during weekends and holidays based on business requirements a possibility
On-call presence preferred while physical personal presence is not possible
Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.
REQUIREMENTS
BA/BS/MS in a science or relevant field required
Master's in Business Administration or relevant field will be preferred
7 - 10 years' experience in the pharmaceutical, biologics or related industry
Prior cGMP experience required
Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must
Experience in Flow Cytometry is a must
5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff
Sound understanding of current Good Manufacturing Practices (cGMPs)
Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation
Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred
Proven experience in a supervisory or managerial position
Demonstrable experience in developing strategic plans based on business needs
Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries
Thorough knowledge of market changes and forces that influence the company
Proficient with computer software: Microsoft Office, Visio
Strong written, oral, and presentational skills
Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers
Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
Excellent organizational and leadership skills
Excellent communication, interpersonal, and presentation skills
Outstanding analytical and problem-solving abilities
Strong business acumen
Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner
Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients Must be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Quality Control (QC) Manager
Quality manager job in Iselin, NJ
Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are looking to add a Quality Control (QC) Manager to their team. Salary/Hourly Rate:
$90k - $115k Annually
Position Overview:
The Quality Control (QC) Manager will lead product-focused quality control operations to ensure that all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control (QC) Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel: 30% to contract manufacturers nationwide
Responsibilities of the Quality Control (QC) Manager:
* Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances.
* Review and approve deviations, investigations, and CAPA documentation to ensure thorough root-cause analysis and effective corrective actions.
* Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are clearly defined and implemented.
* Manage the QC laboratory, including equipment oversight, instrument calibration, cleanliness, and adherence to safety practices.
* Supervise the retention program and maintain product master standards.
* Evaluate consumer complaint samples and support trend analysis.
* Administer and enhance the Quality Management System (QMS) for documents, SOPs, CAPAs, audit records, and inspections.
* Develop and deliver training on cGMP, quality systems, and technical processes.
* Provide leadership, coaching, and performance feedback to QC Specialists.
* Monitor, analyze, and report on quality KPIs to drive improvements across QC operations.
Required Experience/Skills for the Quality Control (QC) Manager:
* 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required).
* Prior supervisory experience. Ability to lead and develop laboratory personnel.
* Strong background in nonconformance management, analytical testing, and release processes.
* Experience operating in cGMP/ISO 22716 environments.
Education Requirements:
* Bachelor's degree in a scientific or engineering discipline (or equivalent experience) is required.
Benefits:
* Comprehensive medical, dental, and vision (including HSA with employer contribution).
* PTO.
* Paid holidays.
* 401(K) and many more!
Director, Clinical Quality Assurance
Quality manager job in New York, NY
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
* Independently conduct audits
* Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
* Facilitate Sponsor health authority inspections of global clinical facilities and study sites
* Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
* Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
* May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
* Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
* 5+ years of experience in GCP auditing.
* Substantial experience in inspection management.
* Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
* Demonstrated ability to operate and influence decision-making processes
* Effective communication skills
* Successful track record of supervising employees and managing cross-cultural differences
* Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
* Knowledge of data integrity controls and systems quality for clinical area
* Strong analytical skills and report writing skills
* Experience with GxP systems including computer system validation and associated regulations, recommended.
* Ability to Travel (approximately 20%)
* Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyQuality Control Manager
Quality manager job in Saddle Brook, NJ
Quality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation.
The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.
Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Establish and maintain policy for documentation of all products and perform internal documentation audits.
Author and review relevant SOPs, validation and other documents.
Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
Control Master Batch Records, distribution and label verification.
Perform line clearance activities as required.
Assign and maintain product lot numbers as applicable.
Ensure materials management nonconformance disposition and release activity as applicable.
Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
Provide support to manufacturing for investigations of deviations, validations, and development of specifications
Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
Perform employee training on QSR and ISO requirements and company quality systems
Perform document control activities as assigned.
Mentor/train/develop and manage Quality Assurance team.
Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements
REQUIREMENTS
BS Degree in biological sciences or equivalent.
Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies.
Analytical and technical troubleshooting skills are a plus.
Proficient with Microsoft Office Suite.
Excellent organizational skills and attention to detail.
Good verbal and written communication skills.
Strong team-oriented interpersonal skills are essential.
Travel may be required
Strong business acumen
Experience with Visio, Microsoft Project and Excel)
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
Ability to multi-task is essential
Flexible and able to adapt to company growth and evolving responsibilities
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.