Director of Quality Compliance Cell Therapy & Inspections
Bristol-Myers Squibb
Bristol Myers Squibb in Summit, NJ is seeking a Director of Quality Compliance for the CAR T manufacturing facility. You will lead site-wide compliance programs, oversee audits, inspections, and regulatory interactions, and drive continuous improvement to ensure inspection readiness across QA, QC and related functions.
The role reports to the Senior Director of Quality Systems & Compliance and requires strong leadership, strategic thinking, and cross-functional collaboration in a regulated
#J-18808-Ljbffr$187.7k - $227.45k
...Bristol Myers Squibb seeks a Director of Quality Compliance for its Cell Therapy manufacturing facility in Summit, New Jersey. This leader will develop and... ...site compliance programs, manage regulatory inspections, conduct internal audits, and ensure adherence to quality...Suggested$187.7k - $227.45k
...of those who do it. Position Summary The Director, Quality Compliance at the BMS Summit West Cell Therapy (CAR T) Manufacturing Facility in Summit, NJ is... ...warehouses, and labs; managing health authority inspections (e.g. FDA, EMA, Health Canada, PMDA); maintaining...SuggestedHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...manufacturing allogeneic and autologous cell therapies derived from the postpartum... ...and age-related disease. Quality Assurance Lead and... ...operations ensuring compliance with FDA, EMA, all... ...routine external audits. Drive inspection readiness and lead all internal...SuggestedContract workWork at officeRelocationFlexible hours
$217.52k - $263.58k
...Position Summary Accountable for leading Patient Safety quality and compliance on all key PS processes through proactive, risk-based oversight... .... Ensures quality findings (i.e deviation, audit and inspection findings) and learnings are translated into sustainable system...SuggestedHourly payFull timeSummer workLocal areaRemote workWorldwideFlexible hoursNight shift- ...Specialist, QA Investigations to provide quality oversight for deviation... ...and related records at the Summit Cell Therapy Facility. You will review... ...corrective actions, and support inspections. The role emphasizes regulatory compliance, data analysis, and cross-functional...Suggested
$120k - $145k
...Pharmaceutical develops and markets high-quality, added-value and cost-effective generic... ...and will manage or support: cGMP compliance assessment of contract manufacturers, the... ...quality complaints Support FDA audits/inspections of the company or its manufacturing partners...Full timeContract workFlexible hours$217.52k - $263.58k
...Bristol Myers Squibb seeks a Director to lead pharmacovigilance and REMS compliance programs, ensuring sustained regulatory compliance and quality excellence across global patient safety... ...PV and REMS programs Lead REMS inspection readiness, compliance monitoring, and...- ...Pharmaceutical develops and markets high-quality, added-value and cost-effective generic... ...and will manage or support: cGMP compliance assessment of contract manufacturers, the... ...quality complaints Support FDA audits/inspections of the company or its manufacturing partners...Contract work
$140k - $165k
...Job Description Job Description Director of Quality | Dietary Supplement Manufacturing... ...Director of Quality to own its quality and compliance function. You'll set the strategy and... ...face of quality during regulatory inspections and customer audits. ** This is an...Work at officeRemote work$116.66k - $141.37k
...Position Summary The Manager, Quality Engineering, Change Control/... ...Review at the Summit Cell Therapy Manufacturing facility is responsible... ...to ensure records are in compliance with regulatory requirements... ...and health authority inspections of facility Communicates effectively...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...comprehensive supply chain solutions. The QA Compliance & Regulatory Affairs Manager is... ...managing and maintaining the company's Quality Management System (QMS) and ensuring compliance... ..., training, supplier qualification, inspection readiness, and continuous improvement...Work at office
$93.27k - $118.29k
...performance improvement and continuous quality improvement (CQI) activities throughout... ...surveys. Serves as the Facility Ethics & Compliance Officer. Essential Functions Plans... ...primary liaison to the Regional Compliance Director and acts as the main point of contact...Work at officeLocal area- Role Executive Director, GxP Center of Excellence (... ...enterprise-wide GxP quality strategies across GCP... ...risk management ensure inspection readiness oversee... ...stakeholders to ensure compliance and operational excellence... ...such as gene or cell therapies Senior Leadership Senior...
$100k - $115k
...most important part of our continued success. The Sr. Director of Housing Operations, Compliance, and Development is a senior leadership role... ...Oversee audits, certifications, reporting requirements, inspections, and compliance calendars. Monitor regulatory changes...Permanent employmentFull timeWork at office$133.2k - $172.37k
...Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing... ...support lentiviral vector manufacturing compliance and lifecycle management. Responsibilities... ...regulatory records and contribute to inspection readiness activities for...- ...devices, oversees BSE program & provides compliance documents to support Health Authority... ...compilation, maintenance, and review of the Quality Module for regulatory submissions... ...Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO). Support...
$120k - $150k
...Sterile Products) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile pharmaceutical products manufactured by... ...support product registrations, submissions, and regulatory inspections related to third-party manufacturing. Assists in...Full timeWork at officeLocal area- ...seeking a QA Product Manager (Sterile Products) to ensure quality, safety, and regulatory compliance for sterile products manufactured by CMOs. You will... ...collaborates with global teams, supports regulatory inspections, and drafts Quality and Technical Agreements. Travel...
$129k - $203.1k
Job DescriptionThe Compliance and Quality Management Systems (CQMS) organization is part of the larger... ...System (QMS). The Associate Director, Quality Systems is responsible for execution... ...application, transparency, and inspection readiness. Reinforce data governance/...Full timeFor contractorsLocal areaFlexible hours$249.1k - $327k
..., we want to hear from you.The Senior Director, Global Regulatory Affairs, Neurology... ...prior to submission to ensure overall quality, compliance and timelines.Lead strategic regulatory... ...congresses, team meetings, audits and inspections)#LI-MIBachelor's degree (Master's preferred...Full timeTemporary workRemote work3 days per week$110k - $130k
...Description Job Description Title: Water Quality Manager Location: Cedar Knolls, NJ (... ...process monitoring, and regulatory compliance programs. This position ensures the... ...compliance matters. 11. Assists with inspections, audits, sanitary surveys, permit requirements...Full timeFor contractorsWork at officeLocal area$142.4k - $224.1k
...critical that consistent, accurate, high-quality data is generated and maintained from... ...based quality oversight, and clinical trial inspection management activities.The CQOM will... ...interpret, and solve complex quality and compliance issues.. Ability to think strategically...Full timeFor contractorsLocal areaRemote workWorldwideFlexible hours$130k - $150k
Quality Engineering Manager FREMONT AREA, CA — 100% onsiteSalary Range:$130,000-$150,000Employment Type... ...SMT, Through-Hole, Functional Test, Final Inspection, and NPI processesKnowledge of quality systems and compliance, including ISO 9001, ISO 13485, AS9100, and IATF...$201.8k - $264.8k
...submission to ensure overall quality, compliance and timelines. Support/... ...team meetings, audits and inspections). Bachelor's degree (Master... ...base salary range for the Director, Global Regulatory Affairs... ...discover and develop innovative therapies to help address unmet...Work at officeRemote work3 days per week$80k - $90k
...are currently looking for a Contract and Quality Control Manager to join our team. As a member... ...the quality, consistency, and contractual compliance of services delivered by external providers. The role uses field inspections, customer feedback, performance data,...Contract workFor contractors$121.35k - $180.85k
...and dependable source of over 760 high-quality generic, specialty and branded... ...motivated Senior Manager or Associate Director, Compliance Americas & UK to join our team. This role... ...monitoring activities, and regulatory inspections, ensuring corrective and preventive actions...Work at office$126k - $176k
...employment decisions based on merit. Senior Quality Assurance Manager is responsible for in-plant process controls to ensure compliance with FreshRealm's Quality and Safety... ...checks and day-to-day functions. Discuss inspection results with those responsible for products...Minimum wageFull timeImmediate start$133.2k - $172.37k
...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...e.g., Process Design, MSAT, Quality, Manufacturing, Supply Chain... ...operations. ~ Contribute to inspection readiness activities,... ...manufacturing, supply, regulatory compliance, and health authority...Full timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours- ...Documentation Supervisor (Mfg. & Pkg.) to lead our Quality Assurance documentation team and manage daily compliance operations. You will serve as the primary... ...finished products, and packaging/labeling sampling and inspection activities. Handle and maintain Quality...Full time
$150k - $175k
...00/yr - $175,000.00/yr Vice President - GxP Quality Recruitment at EPM Scientific Associate Director, GCP Quality Compliance - Remote Summary An industry leader in regenerative... ...with regulatory requirements and lead inspections and audits by regulatory agencies. Act as...Full timeRemote work
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