Director, GMP Quality & Regulatory Assurance
Kymera Therapeutics
Kymera Therapeutics in Watertown, MA is seeking a Director of Quality to serve as a GMP subject matter expert across manufacturing, stability, analytical and distribution activities performed at external suppliers. The role ensures compliance with FDA/EMA/ICH and supports regulatory submissions. You will oversee outsourcing quality, review batch records, manage deviations and investigations, develop quality metrics, and partner with cross-functional teams to advance late-stage manufacturing and #J-18808-Ljbffr Kymera Therapeutics
- ...is seeking a highly experienced leader for the Quality team to drive gRNA, mRNA, and LNP analytical methodologies and GMP testing. This role partners with Research,... ...cross‑functional teams, mentor staff, and author regulatory submissions while ensuring compliance with FDA...Regulatory
- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review... ...and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or Boston with travel...Regulatory
$200k - $260k
...the Company on LinkedIn and X. We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing... ...Analytical Sciences, Quality Control, and Supply Chain, and Regulatory teams to embed quality oversight into program...RegulatoryContract workTemporary workFlexible hours- Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products... ...spanning IND reviews, SOP authoring, and regulatory inspections. #J-18808-Ljbffr Amylyx PharmaceuticalsRegulatoryContract work
- ...Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end... ...commercial programs, ensuring compliance with GMP/GDP standards. The role involves... ..., managing quality systems, supporting regulatory inspections, and collaborating with internal...RegulatoryRemote job
$160k - $180k
...beyond About the Role As the Associate Director, GMP Quality , reporting to the Head of GMP... ...with other functional teams such CMC, Regulatory and Supply Chain to prepare submissions... ...guidance as they relate to GMP Quality Assurance Experience Minimum of 8 years' work experience...RegulatoryWork experience placementWork at officeFlexible hours$160k - $200k
Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible... ...that transfers are executed in compliance with global regulatory requirements, company quality standards, and product...RegulatoryWork at officeRemote work$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible... ...align with patient safety, product quality, regulatory expectations, and business continuity.This role serves...RegulatoryFull timeContract workSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of... ...and application of quality assurance and compliance. The incumbent is responsible... ...goals and compliance with all regulatory requirements, refining goals and projects...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$200k - $217k
..., strategic, and hands-on Associate Director, GMP Quality Drug Product to serve as the end-to-... ...strengthen quality systems, support global regulatory inspections and submissions, drive... ...~ Serve as the Quality Assurance lead and primary quality representative...RegulatoryFull timeContract workFor contractors$196k - $230k
...LinkedIn and Facebook.Role Summary:The Director, Quality Management Systems is a quality leader... ...ready, risk-based, and aligned with global regulatory expectations. The Director will partner... ..., with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Demonstrated leadership...RegulatoryLocal area$190k - $230k
...and Facebook.Role Summary:The Director, Quality Control leads global Quality... ...evolving organizational and regulatory requirements. This is an... ...activitiesCollaborates closely with Quality Assurance, Manufacturing, CMC, Supply... ...or Quality Control within a GMP-regulated environmentStrong...RegulatoryContract workLocal area$252k - $269k
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight... ..., anticipate and respond to evolving regulatory expectations. Responsible for the... ...appropriate division and touchpoints with GMP.Audit & Inspection Management• Lead the...RegulatoryContract workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...Responsibilities Lead and execute the quality strategy across Repligen’s... ...accountability for Quality Assurance, Quality Systems, Quality... ...audits, and interactions with regulatory agencies. Drive the... ...programs is highly desirable. GMP knowledge is highly desirable...Regulatory
$210k - $220k
...professional to join our team as Director of QC, supporting release,... ...release timing Ensure GMP lab is maintained in a constant... ...documents and ensuring QC support of Quality/CMC documentation Drive... ..., EP, ICH, and Cell Therapy regulatory guidance Management of...RegulatoryLocal areaFlexible hoursShift work$215k - $235k
...Decoding The Role: The Quality team is seeking a... ...analytical methodologies and GMP testing. The... ...Manufacturing, and Quality Assurance, to transfer, qualify... ...Your Impact: As the Director, Quality Control, you... ...Author and review of regulatory submissions, technical...RegulatoryFlexible hours- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview An innovative biotechnology... ..., and drive phase-appropriate GMP compliance across a growing modality portfolio... ...documentation. Quality Systems & Regulatory Readiness Lead QC investigations, OOS...Regulatory
$103.5k - $162.69k
...the best of my knowledge.Job DescriptionTitle: Manager, Quality Systems & Data Analytics, R&D GMP QualityLocation: Lexington, MAAbout the role:As a... ...opportunities before they impact product quality, patients, or regulatory outcomes. You will transform enterprise quality data...RegulatoryMinimum wageTemporary workLocal area$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront... ...in aligning with ICH Q9 and global regulatory expectations. Reporting to the Director... ...MS/PhD) preferred.At least 10 years of GMP and Quality experience, including 5+...RegulatoryFull timeTemporary workLocal area- ...We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations... ...overseeing external testing labs in a GMP environment; you will also be responsible... ...requirements, Crescent standards, and regulatory expectations. Generate COAs for intermediate...RegulatoryContract workTemporary workWork at officeFlexible hours
$195k - $275k
...you’ll make an impact: The Director will act as a Quality subject matter expert for... ...Manufacturing Practices (GMP) activities. The individual... ...preparation and review of regulatory filing submissions (IND/IMPD... ...4 years in a GMP quality assurance role. Experience in a...RegulatoryContract work$172k - $194k
...responsible for providing CMC quality oversight of drug... ...stages. As the GMP quality expert, this role... ...anticipate hiring the Associate Director, Quality Operations in... ...QA review on INDs. Assure that source data and information used in regulatory submissions and validation...RegulatoryContract workLocal areaRemote work$250k - $273k
The Senior Director, Quality Compliance is responsible for providing strategic... ..., ensuring alignment with regulatory requirements and industry... ...years of experience in Quality Assurance/Compliance within the... ...Demonstrated leadership experience in GMP, GCP, and/or GLP...RegulatoryWork at officeRemote work$190k - $260k
...advanced therapies faster and more efficiently.The Role:The Director, Quality Systems and Compliance provides strategic direction and oversight... ..., and Business System Ownership to ensure execution meets regulatory requirements, industry best practices, and modern digital,...Regulatory$185.5k - $344.5k
...Cambridge MAInternal: DirectorLI#-HybridThis role oversees the Study Quality and Compliance team within the Toxicology line function of... ...are of high-quality and are ready in a timely manner for regulatory submissions, which includes SEND datasets from external CRO and...RegulatoryFull time- ...Cytonome seeks a Director of Quality & Regulatory to lead the QARA function in Lexington, MA. This full-time role entails steering quality, regulatory... ...ensuring compliance with ISO 9001, ISO 13485, FDA QSR, GMP, and related regulations. Ideal candidates will have 10+ years...RegulatoryFull time
- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection... ...and associated governance across all GMP areas. This position focuses not just... ...testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$251.77k - $307.72k
...an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality compliance organization. This leadership role is... ...QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policiesDevelop...RegulatoryFull time$124.63k - $179.22k
The Sr. Manager Training & Quality Systems will report to the Director Quality Systems and be responsible for the... ...partner groups who support GLP, GCP and GMP activities to identify, enhance and... ...training programSupport audits and regulatory authority inspections by providing...Regulatory$160k - $185k
...Facebook.Role Summary:The Senior Manager, GMP QA Operations oversees quality activities associated with contract... ...activities align with applicable regulatory requirements, industry standards,... ...related work experience in Quality Assurance or closely related role within...RegulatoryContract workWork experience placementLocal areaFlexible hours
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