Senior GMP QA Manager: Batch Release & QMS
Proclinical Group
Proclinical is seeking a Sr Manager GMP QA for a contract role in Boston, MA to support batch disposition and core QMS activities. Hands-on GMP QA experience in pharmaceutical manufacturing, especially with small-molecule substances and oral solids, is highly valued. The candidate will provide quality oversight for batch review, deviations, CAPAs, change control, and product complaints, collaborating with internal teams and external partners to maintain GMP compliance. #J-18808-Ljbffr Proclinical Group
$190k - $270k
...supporting the Head of QA with oversight of... ...of external GMP Quality operations... ...necessary. Review batch records and analytical... ...patients. Ensure change management program is used... ...QualityDocs, Veeva QMS Systems, Learning Management... ...results to senior management via management...SeniorFlexible hours- Sr Manager GMP QA - Contract - Boston, MA Ensuring compliant product release while strengthening quality systems across the manufacturing lifecycle... ...a Sr Manager GMP QA to support batch disposition and core GMP Quality Management System (QMS) activities. This position...SeniorContract work
- Position Overview Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS), reporting to the VP, Global Quality, to build and lead... ...leadership team, this individual will partner closely with GMP and GCP Quality leaders to design and implement...SeniorLocal areaRemote work3 days per week
- ...A leading healthcare institution in Boston seeks a Sr. Principal Scientist to oversee operations in a GMP lab, focusing on the production and quality control of radiopharmaceuticals. The ideal candidate will have extensive experience in aseptic operations, knowledge of...Senior
$118.4k - $177.6k
The GMP Quality Operations Manager is recognized internally as an expert... ...Manager will provide QA support of manufacturing... ...including review of batch data, batch records,... ...process data, EM data, QC release testing, and other... ...visibility into QMS performance and process...SuggestedSummer work$213.6k - $320.4k
## Senior Director, Quality Systems/QMSApplylocations:... ...effectiveness of the Quality Management System. The role is... ...effectiveness throughout the global QMS.**Key Responsibilities:*... ...+ Partners with QA leadership and enable... ...Quality oversight experience (GMP and/or GCP with...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week$122k - $150k
...Review and approve Service Provider GMP documentation Review and approve master batch/packaging records Review executed... ...in Veeva QualityDocs and Veeva QMS a plus Demonstrates proven track record... ..., well organized, and able to manage multiple projects Ability to interact...SeniorLocal areaFlexible hours3 days per week- ...leading firm in IT Services and Consulting is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role includes... ...GMP manufacturing, requiring a strong background in QA operations and experience in batch record reviews. Ideal candidates should have...Senior
- ...specific products. This position manages the design, implementation and delivery of QA processes, programs and policies... ...at the time of every new software release. It supports the Harvard... ...years working in QA, achieving a senior level of responsibility preferred...SeniorFor contractorsWork experience placement
$127k - $172k
.... Description The Senior IT Business Analyst... ...Laboratory Practice) and GMP (Good Manufacturing Practice) Systems Manager is responsible for... ...Quality Assurance (QA) and Regulatory... ...Systems (QMS), quality documentation... ...validation testing and release) Provide systems qualification...SeniorTemporary workSummer workWork at officeLocal area$260k - $320k
Beam Therapeutics in Cambridge is seeking a Senior Director of Product Quality Assurance who will oversee GMP compliance and quality support for external manufacturing... ...sector, with extensive experience in quality management and CDMO oversight. Competitive salary range...Senior- ...operations. The role involves leading quality initiatives, maintaining relationships with technical teams, and ensuring adherence to GMP standards. The ideal candidate should possess a Bachelor's degree in a scientific field, with over 15 years of experience in Quality...Senior
$134k - $186k
...Ultrasound QMS Manager In this role you Are responsible for overseeing the strategic management of the QMS department, aligning it... ...solutions to enhance quality and compliance. • Serves as a senior quality advisor and key point of contact for regulatory bodies...Full timeWork at officeLocal areaRemote workWork visaRelocation package3 days per week$66.8k - $124k
...seeking an experienced Senior QA Specialist, RLT... ...Specialist for Radioligand GMP Manufacturing... ...manufactured, tested, and released in full compliance... ..., supports batch review and release, manages deviations and CAPAs... ...implementing a global QMS adhering to EU GMP Vol...Senior$134.62k - $201.25k
The Senior Manager, Quality Control (Small Molecules) will execute... ...supporting small‑molecule GMP manufacturing , product release, and regulatory compliance... ...product testing. Supports QC batch disposition and release... ...closely with Manufacturing, QA, CMC, Regulatory Affairs,...SeniorContract workTemporary workLocal areaFlexible hours$55 - $60 per hour
...Technologies Inc. Title GMP Operational Quality Senior Specialist... ...About the Role Join a QA team in the Cell & Gene... ...commercial drug product) Batch record review, batch... ...investigations, CAPAs, OOS/OOT management Quality on the Floor... ...Support product release, COAs, change...SeniorHourly payContract work$161.5k - $202k
...Position The Associate Director, GMP Quality Assurance is... ...activities, audits CDMOs, conducts batch release, and performs investigations.... ..., and reports Perform QA review of executed batch records... ...diligence audits Apply risk management principles (e.g., FMEA) to guide...Work at officeLocal areaRelocation3 days per week$260k - $320k
...Position Overview The Senior Director, Product... ...in the areas of GMP compliance with Beam... ...a key relationship manager CDMOs/external partners... ...to support product release in a compliant and... .... Oversee external batch record review and... ...as well as internal QA systems in a...SeniorContract workWorldwide- Cognizant is seeking a Senior Healthcare QA Manager - Facets Claims & Medicare to ensure the quality, accuracy, and reliability of healthcare claims processing during Facets transformations. You will lead end-to-end testing across front-end and backend and Collaborate...SeniorRemote job
- ...prominent engineering firm in Boston is seeking an experienced Senior QAQC Project Manager to ensure compliance with technical standards, collaborate... ...15+ years of experience, and have a strong grasp of QA/QC systems and structural design codes. This role offers a...Senior
$285k - $350k
...commercial product lifecycle management. The Head of Quality... ...activities across GCP, GMP, and GPV functions.... ...distribution partners. Oversee batch record review (Executed... ...Responsible for final release or other disposition of... ...transferring into a QA role: Chemical...$125k - $150k
...Assurance / Quality Control (QA/QC) Lead MarvelBiome, Inc.... ...will be responsible for managing day‑to‑day GxP quality systems... ...Management Systems (QMS) to review and interpret data... ...agreements. Review and approve GMP documentation, including batch records, deviations, CAPAs,...Contract work$128k - $142k
...ensure compliance with FDA/EU cGMP requirements and will be responsible for analytical lifecycle oversight, cleaning validation, and batch manufacturing support. In this role, you will interact with regulatory bodies and will need a strong background in pharmaceutical...Senior$80k - $200k
...transformation of our customers’ Complaints Management processes and technology. The MedTech... ...teams to ensure delivery success across QMS implementations. Responsibilities Review... ...Qualifications 8+ years of experience in GMP Systems ownership or Software Consulting...SeniorLocal areaFlexible hours- Osprey Life Sciences in Cambridge, Massachusetts, is seeking a Veeva Vault QMS Project Manager to lead the implementation of Veeva Vault QMS within a growing biotechnology organization. The ideal candidate will be highly experienced in managing Veeva Vault implementations...
$133.8k - $200.6k
...The Operational Area Quality Senior Manager provides quality leadership for... ..., product disposition, batch record review, deviations, investigations... ..., ensuring compliance with GMP, regulatory requirements, and... ...to support timely release of clinical and commercial product...SeniorContract workSummer workRemote work2 days per week$160k - $190k
Senior Manager/Associate Director, Quality Control / Analytical Development... ...product (DP) in‑process, release and stability testing. Review... ...specifications, CoAs, executed batch record etc) and quality events... ...therapeutic candidates in a GMP‑compliant manner. Author and...SeniorFull timeContract workLocal area$130k - $165k
Ratio Therapeutics is seeking a Scientist/Senior Scientist to join their team in Boston. The successful candidate will develop GMP manufacturing processes and ensure compliance with regulations. A PhD in life sciences with relevant experience is required, along with a...Senior- Verista is seeking a Senior Quality Engineer / Senior Quality GxP Auditor to provide QA oversight for GMP manufacturing operations in cell and gene therapy and to partner with cross-functional teams to ensure compliance across the product lifecycle. The role requires strong...Senior
- ...MA, is seeking a qualified professional to oversee life cycle management and scheduling within the FDA-regulated industry. The position... ...experience in operations and maintenance, along with knowledge of GMP and CMMS systems. Candidates should be adept at managing work...Senior
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