Senior Director, GMP Quality & Compliance Leader
Generate:Biomedicines
Generate:Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems and provide independent oversight of CDMOs and contract labs. You will work with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain to support programs from development through commercialization. The ideal candidate offers 15+ years in biopharma, deep GMP/GLP expertise, and a proven track record in quality strategy, audits, and regulatory readiness. #J-18808-Ljbffr Generate:Biomedicines
$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems... .... Serve as an enterprise Quality leader and strategic advisor to Technical Operations... ...data integrity, computerized systems compliance, and alignment with global regulatory...SeniorContract workFor contractorsShift work- ...GMP Operational Quality Senior Manager The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple complex projects with...SeniorContract workShift work
- Scorpion Therapeutics Associate Director, GMP Quality will lead QA activities for GMP release of Clinical Trial Materials and Commercial batches, oversee MP and EQ batch records, and champion regulatory readiness across NDA and commercial launches. Key responsibilities...Senior
- Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products in development stages. The role ensures compliance with GMP/GDP standards and supervises activities with contract...SeniorContract work
- Generate Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems, overseeing CDMOs and contract labs... ...and company requirements are met. This hands-on leader partners with Technical Operations, Regulatory Affairs, Clinical...SeniorContract work
- ...components manufacturer located in Massachusetts is searching for a Site Quality Manager to oversee all quality functions. The successful candidate will manage the Quality Management System ensuring compliance with AS9100 and ISO 9001. This role involves leading a team to...Senior
$240k - $285k
...LinkedIn and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and... ...management. This role ensures global GMP compliance, inspection readiness, and robust analytical... ...and results.Empower team members and leaders to exercise sound judgment, take...SeniorContract workLocal area$191.25k - $260k
...Senior Director, Quality Make a global impact—join Repligen. We're united by... ...highest standards of quality, compliance, and customer satisfaction... ..., and senior business leaders to establish a culture of quality... ...is highly desirable. GMP knowledge is highly desirable...SeniorWorldwideFlexible hours$252k - $269k
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes... .../GCP/GVP quality programs to ensure compliance across global clinical trials. This... ...division and touchpoints with GMP.Audit & Inspection Management• Lead the...SeniorContract workWork at officeLocal areaWorldwideFlexible hours3 days per week$216k - $324k
...DescriptionVertex is seeking a Senior Director, Head of Quality Control to lead QC... ...manufacturing network. This leader will be responsible for building... ...monitoring, and QC compliance across the external network... ...oversightStrong knowledge of GMP laboratory operations,...SeniorFull timeContract workSummer workRemote workFlexible hours2 days per week$235k - $260k
...Position Purpose: The Sr. Director, Quality Control, will be... ...and execution of Stoke’s GMP Quality Management Plan for compliance and risk monitoring for... ...candidate is a seasoned QC leader with expertise in... ...and thought partner to senior leadership. Establish...SeniorFull timeTemporary workWork at office- Novartis Group of Companies in Cambridge, MA seeks a Director to oversee the Study Quality and Compliance team within Preclinical Safety. You will drive GLP compliance, manage data for internal and external toxicology studies, and implement software to track study information...
- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to drive supplier quality strategy, ensure regulatory compliance, and lead cross-functional collaboration across SQE, engineering, and procurement. The role requires 10+ years in quality or related...SeniorWork at office
$228k - $342k
Job DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP... ...position summary:The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal leader within the Quality... ...Quality experience (e.g., GMP, GCP, IT). Experience working...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team... ...of quality assurance and compliance. The incumbent is responsible for development... ...with the ability to influence leaders, customers, or vendors to adopt of a...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$250k - $302k
...the office to be considered. The Senior Director, Quality Operations is a senior quality leader responsible for providing... ...service providers operate in full compliance with global regulatory requirements... ...management. Deep knowledge of GMP regulations (FDA, EMA, ICH) applicable...SeniorOngoing contractFull timeContract workWork at officeFlexible hours3 days per week$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... ...electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations...SeniorContract workTemporary workFlexible hours- ...Housing Authority ("CHA"), a leader in developing and maintaining... ...developing and managing safe, high quality, affordable housing for low-... ...is seeking a highly capable Senior Program Manager - Data &... ...data quality, stewardship and compliance. • Python - exposure to Python...SeniorWork at officeWork from homeMonday to FridayFlexible hours2 days per week
$217.6k - $326.4k
Job DescriptionGeneral Summary:The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies... ..., proactive and sustainable clinical quality, and compliance for assigned programs. This individual will integrate end...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$171.2k - $256.8k
...Fenway area of Boston, Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading quality assurance... ...across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory...SeniorContract work$250k - $273k
The Senior Director, Quality Compliance is responsible for providing strategic leadership and oversight of the organization’s global quality compliance... ...industry.Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and commercial...SeniorWork at officeRemote work$116k - $174k
...Massachusetts.Summary This role will report to the Director of Quality and operate across departments,... ...in a matrixed, outsourced model where compliance and inspection readiness are key to our... ..., Quality Assurance, will provide GMP QA oversight for Tango’s CMC development...Contract work$95k - $115k
...Senior Proposal Lead SMMA is seeking an experienced Senior Proposal... ...Working closely with market leaders, technical staff, and... ...project management, and high-quality deliverables. Key Responsibilities... ...Develop proposal schedules, compliance matrices, outlines,...SeniorWork from home- This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials. This leader ensures the organization is ready for inspections, implements and...SeniorContract work
- Integer Holdings is seeking a Quality Inspector to lead inspections from raw material intake through final assembly, ensuring GMP-compliant quality and documentation. You will identify non-conforming materials and support NCR processes while maintaining Calibrations and...Senior
$117k - $165k
...We are looking for a highly motivated Quality Systems Manager/Senior Manager, with a strong background in... ...contributor within Quality Systems & Compliance, you’ll implement Obsidian’s eQMS and... ...Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations...SeniorFull timeLocal areaFlexible hours- ...strategies. Develop proposal schedules, compliance matrices, outlines, assignments, and review processes to ensure timely, high-quality submissions. Compose and format documents... ...graphic/layout skills. Collaborate with market leaders, technical staff, and subject matter...Senior
- SHINE Technologies, LLC is seeking a GMP Senior Stability Specialist to lead stability programs and ensure data integrity and regulatory readiness. The role requires on-site presence in Massachusetts and collaboration with QC, QA, Manufacturing, and Regulatory Affairs....Senior
- ...labeling, packaging, and inspection for combination products in a GMP-regulated environment. This role requires proficiency in... ...improvements, training of junior associates, and adherence to quality and compliance objectives #J-18808-Ljbffr Initial Therapeutics, Inc.
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory... ..., and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsSenior
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