Director, GMP QA Operations Biotech Quality Leader
$188k - $230kDyne Tx
A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will have over 10 years of experience in GMP Quality Operations and leadership experience in a biotech environment. This role will ensure compliance with quality standards and foster cross-functional collaboration to support continuous improvement initiatives. Competitive salary offered, ranging from $188,000 to $230,000 USD. #J-18808-Ljbffr
$94.6k - $141.8k
...Job Description General Summary: The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic... ...leadership of complex quality initiatives and QA oversight of external manufacturing operations...OperationsQualityContract workSummer workRemote workFlexible hours2 days per week- CRISPR Therapeutics Inc. is seeking a Quality Site Head to lead the Quality function at the internal manufacturing site and guide QA strategy across operations in Boston-based facilities. The role emphasizes excellence in GMP manufacturing, regulatory readiness, and continuous...OperationsQuality
- ...Vertex Pharmaceuticals Incorporated is seeking an Associate Director, GMP Operational Quality to oversee a Quality team, ensure compliant GMP activities... ...coordinate with internal and external partners, manage QA for change controls, investigations, and CAPAs, and support...OperationsQuality
$210k - $300k
...The Senior Director, Integrated Solutions Execution &... ...Integrated Solutions, this leader develops team... ...Manufacturing, Supply Chain, Quality, Finance, Legal, and other... ..., Life Sciences, Operations, or a related technical... ...in process engineering, GMP manufacturing, scale-up...OperationsQualityWorldwideFlexible hours$188k - $230k
...A biotechnology firm based in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing quality in external manufacturing and overseeing GMP activities. The ideal candidate will have at least 10 years of experience in GMP operations, demonstrating...OperationsQuality$159.8k - $239.8k
Job DescriptionThe Associate Director of GMP Operational Quality Assurance is an advanced technical resource and is recognized as an expert internally... ...and/or changes for finished goods GMP operationsServe as QA assessor/approver: resolve gaps, approve change plans, classifications...OperationsQualityFull timeContract workWork experience placementSummer work$185k - $225k
...seeking an Associate Director, Quality Control to lead the Beam... ...sound, and timely GMP testing while maintaining... ...for routine GMP testing operations supporting Beam’s... ...role requires a strong leader who can balance daily... ...key QC interface with QA, Manufacturing, MS&T,...OperationsQualityFull time$185k - $225k
...Position Overview:The Associate Director of Product Quality Assurance (PQA) will be... ...of Quality support for GMP operations. Quality oversight will include... ...in the pharmaceutical/biotech industry in combination with... ...CDMOs as well as internal QA systems in a virtual environment...OperationsQualityFull timeContract workWorldwide$175.8k - $217.1k
...Associate Director, Quality Assurance Gmp Training MgmtThis role will provide Quality Assurance oversight... ...Management related to internal GMP operations at both the Gene Therapy Manufacturing... ...training.Work closely with Site Leaders to identify needs for enhanced training...OperationsQualityFull timeWork at officeLocal area- Beam Therapeutics Inc. seeks an Associate Director of Product Quality Assurance to lead phase-appropriate quality oversight of GMP operations, including internal testing and external manufacturing partners. The role drives risk management, investigations and release activities...OperationsQuality
$188k - $230k
...families and communities. Learn more at , and follow us on X, LinkedIn and Facebook.Role Summary:The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development...OperationsQualityLocal area$116k - $174k
...Boston, Massachusetts.Summary This role will report to the Director of Quality and operate across departments, supporting regulated activities and... ...development cycle. The Manager, Quality Assurance, will provide GMP QA oversight for Tango’s CMC development programs and...OperationsQualityContract work$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... ...processes across clinical trials and laboratory operations. Partnering cross-functionally across the organization...OperationsQualityContract work- ...Vertex Pharmaceuticals LLC is seeking an Associate Director of GMP Operational Quality Assurance to provide expert guidance on quality and regulatory compliance across multiple validation projects for Finished Goods launched globally. The role leads QbD initiatives, CPV...Quality
$160k - $195k
...and Facebook.Role Summary:The Associate Director, Quality Management Systems is a key member of... ...supports Dyne’s transition to commercial operations. This role is responsible for key... ..., with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Demonstrated experience...OperationsQualityLocal area- ...strategy for cutting-edge biotech facilities that enable... ...Life Science Sector Leader is responsible for driving... ...vision, growth, and operational excellence of the Life... ...standards, best practices, and quality benchmarks for life... ..., pilot plants, and GMP manufacturing spaces tailored...OperationsQuality
$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team... ...to support GMP activitiesOversee the QA support of Change Controls, GMP... ...concepts with the ability to influence leaders, customers, or vendors to adopt of a...QualityFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$138.64k - $187.57k
...helped pioneer the world of biotech in our fight against the world... ...your career.Principal Product Quality Leader (Synthetics)What you will... ...ownership, authoring and review of GMP and regulatory documents,... ...degree & 2 years of Quality, Operations, Scientific, or Manufacturing...OperationsQualityFull timeRemote workFlexible hours- ...Description The Associate Director, Quality Systems leads the strategy,... ...viral vector and fill-finish operations. The role owns core quality... ...Quality experience working in a GMP biotechnology manufacturing... ...in Quality Systems in a GMP biotech setting ~ Preferred...OperationsQualityWork at officeMonday to Friday3 days per week
- ...Safety to lead the EHS program across the site. You will partner with Manufacturing, Quality, Facilities, Engineering, and R&D to sustain a safe, compliant workplace supporting cGMP operations. The role focuses on developing policies, training, and systems to minimize...OperationsQuality
- ...therapeutic candidates for well-validated targets.Reporting to the Director, Quality Operations, the Associate Director, Quality Operations will lead... ...introductions, commercial launch readiness, and ongoing GMP readiness across EU and international manufacturing and supply...OperationsQualityWork at officeLocal areaImmediate startRemote work
- CRISPR Therapeutics, Inc. is recruiting a Quality Site Head to oversee the Quality... ...will drive a culture of quality, oversee GMP-compliant operations, and prepare for Health Authority inspections... ...requires 15-20+ years in biopharma QA, deep regulatory knowledge, and a proven...OperationsQuality
$185k - $215k
...potential to improve both health and quality of life for patients with limited options... ...expanding our global presence with operations in the U.S., Japan, Singapore, South... .... Position Overview The Associate Director, Thought Leader Liaison (TLL) is a highly visible, field...OperationsQualityTemporary workWork at officeFlexible hoursAfternoon shift- ...A GMP Quality Assurance Specialist is being sought for a 12-month contract in Boston to support clinical and commercial... ..., deviation triage, and guidance to manufacturing operations. The ideal candidate has 5+ years of GMP QA experience in a cGMP environment, with 2-3 years...OperationsQualityContract workAfternoon shift
- ...seeking an experienced Technical Operations leader to help drive the technical... ...Agenus is seeking a Director / Executive Director, Technical... ...Agenus's clinical, regulatory, quality, supply, and... ...accordance with applicable GMP requirements, ICH guidelines...OperationsQuality
- ...autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as... ...manages direct reports as a people leader, and is a leader for strategies,... ...cross-functional collaboration.· Ensure high-quality statistical input across entire drug development...QualityFull timeWork at officeFlexible hours
$45k
...scientists, small and medium biotech, to the largest... ...development organization operating 11 divisions across 5... ...As Associate Director of Antibody Discovery... ...closely with project leaders overseeing the successful... ...accountable for high quality partner communication...OperationsQualityApprenticeshipWork at officeImmediate startFlexible hours$161.5k - $218.5k
OverviewThe Associate Director, Downstream, Emerging Modalities,... ...Development, Regulatory, Technical Operations, Quality, and CDMO partners to... ...technically strong downstream leader who can define purification... ...process transfer, and support of GMP manufacturing campaigns....OperationsQualityFull timeTemporary workLocal areaFlexible hours- ...Pharmaceuticals, Inc. is seeking an Associate Director of Quality Control to lead commercial QC operations within a fully outsourced network... ..., Regulatory Affairs, and QA to ensure timely commercial lot... ...experience, strong knowledge of GMP and regulatory expectations, and...OperationsQuality
- ...argenx, a leading biotech company, seeks a Disease Area Lead Statistician to guide strategic statistical direction across Early Development... ...cross-functional teams to deliver robust analyses and high-quality deliverables. You will drive innovative statistical...Quality
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