Senior GMP QA Manager: External Manufacturing & Compliance
Apnimed
Apnimed, based in Cambridge, MA, is seeking a Senior Manager, GMP Quality Assurance to lead quality oversight across external manufacturing and testing partners as we move toward commercial readiness. The role reports to the Associate Director, GMP QA and collaborates with Manufacturing, CMC, Regulatory, and Supply Chain to ensure compliant documentation and CAPA processes. The position emphasizes QA leadership, regulatory readiness, and continuous improvement while supporting NDA submissions #J-18808-Ljbffr Apnimed
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior GMP QA Manager: External Manufacturing & Compliance in Cambridge, MA vacancy
- ...The GMP Operational Quality Senior Manager is an advanced technical resource... ...quality assurance and compliance. This role... ...projects with emphasis on QA GMP disposition of... ...with internally and external business partners to... ...GMP Drug Product manufacturing Experience managing...SeniorContract workShift work
BioPharma Consulting JAD Group
Boston, MA3 days ago - A major IT staffing company is seeking a Quality Compliance Investigator to manage and lead investigations into GMP operations. The candidate will support internal and external audits, ensure compliance with CGMP standards, and track corrective actions effectively. With...Senior
- ...Senior Director of GMP Quality will establish and maintain quality... ...oversight of manufacturing partners and testing... ...and ensure regulatory compliance. This hands-on leadership... ...relationships with external partners including... ...audits and performance management Advise Technical...SeniorContract work
Generate Biomedicines
Somerville, MA22 days ago $163k - $186k
...therapies to address unmet patient needs.Role Summary The Senior Manager, External Manufacturing position supports various manufacturing activities such... ...of the businessKeep current with industry regulatory, compliance trends and publicationsComply with appropriate...SeniorContract workTemporary workFlexible hoursLes Laboratoires Servier
Boston, MA1 day ago- Judge Group, Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical sites, laboratories, suppliers, CMOs, and quality systems. This role focuses on regulatory compliance, inspection readiness, and quality-system effectiveness...SeniorRemote job
$95 - $135 per hour
...Description: Title: Principal GMP Compliance Auditor Type: 6+ Month... ...international Seeking a Senior Principal GMP Compliance... ...across pharmaceutical manufacturing sites, laboratories, suppliers... ..., documentation, and risk management. Support inspection readiness...SeniorHourly payContract workRemote work$116k - $174k
...matrixed, outsourced model where compliance and inspection readiness are... ...through the development cycle. The Manager, Quality Assurance, will provide GMP QA oversight for Tango’s CMC... ...Technical Operations, Regulatory, and external manufacturing partners to ensure compliance...Contract workTango Therapeutics
Boston, MA3 days ago$210k - $290k
The Role: The Senior Director, GMP Quality will build/support... ...contract development and manufacturing organizations (CDMOs... ..., Supply Chain, external vendors, and... ..., product lifecycle management, and regulatory commitments... ...computerized systems compliance, and alignment with...SeniorContract workFor contractorsShift workGenerate Biomedicines
Somerville, MA4 days ago- ....comDescriptionThe Senior IT Business Analyst... ...Laboratory Practice) and GMP (Good Manufacturing Practice) Systems Manager is responsible for... ...Quality Assurance (QA) and Regulatory... ...validation and compliance support of laboratory... ...business partners, external vendors, and service...SeniorWork at office
Planet Pharma
Lexington, MA1 day ago - ...Senior Manager overseeing manufacturing operations and supervisory team at a pharmaceutical facility. Ensures safe, compliant, and efficient execution... ..., cleaning, and batch documentation Monitor compliance, batch records, and escalate operational or quality issues...SeniorAfternoon shift
Vertex Pharmaceuticals
Boston, MA22 days ago $228k - $342k
...position summary:The Senior Director,... ...Digital Systems & Compliance, serves as a... ...integrity, master data management, computerized... ..., Regulatory, Manufacturing, Clinical, and... ...with QA leadership and... ...experience (e.g., GMP, GCP, IT). Experience... ...who bring an external perspective, demonstrate...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA1 day ago- Cox Engineering in Randolph, Massachusetts is seeking a QA/QC Manager to lead the Quality function at the Cambridgeport manufacturing plant. This hands-on leadership role includes ensuring all products meet stringent quality standards, maintaining the quality management...Senior
- ...and 2025! Summary: The Senior Manager, GMP Quality Assurance plays... ...Apnimed’s products are manufactured, tested, and released in full compliance with global regulatory... ...particular emphasis on external manufacturing and testing... ...: Provide day‑to‑day QA support for GMP manufacturing...SeniorFlexible hours
$130k - $167k
...around us. We design, develop, manufacture, and service highly complex,... ...closely with Product Management, Engineering, Supply Chain,... ...and business objectives. The Senior Manager, Manufacturing Operations... ...with business demand.Ensure compliance with applicable quality,...SeniorShift workVeeco
Waltham, MA4 days ago- ...Cambridge, MA is seeking an experienced Director of Quality Assurance to lead External and CMC QA. This role provides governance over contract manufacturers and labs, ensuring GMP/GxP compliance and product release for clinical and commercial use. You will partner with...Contract work
$188k - $230k
...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... ...deliver outcomes to advance programs within compliance. The Director is responsible for...Local areaDyne Therapeutics
Waltham, MA17 hours ago- ...programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The director partners closely... ...behavior •Strong speaking skills in large group setting with Senior Level clients. Preferred Certifications •CP-FS (...SeniorLocal areaRemote workFlexible hoursShift work
Flik Hospitality Group
Boston, MA5 days ago $150k - $195k
...improve their health and performance.WHOOP is hiring a Senior Global Supply Manager, Contract Manufacturing to lead the commercial strategy and management of... ...structures.Ability to influence senior internal and external stakeholders, exercise sound judgment in ambiguous situations...SeniorFull timeContract workWork at officeRelocationWHOOP
Boston, MA17 hours ago$250k - $273k
...most.We're seeking a Senior Director, Quality Compliance reporting to the VP... ...supplier quality management program for CMOs, CROs... ...compliance of external partners.Lead development... ....Partner with manufacturing, supply chain, and... ...leadership experience in GMP, GCP, and/or GLP...SeniorWork at officeKiniksa Pharmaceuticals
Lexington, MA2 days ago- A leading IT staffing company in Massachusetts is seeking a qualified individual to investigate GMP operations and ensure compliance with regulations. The ideal candidate will have a Master’s or Bachelor’s degree in Engineering or Life Sciences, coupled with extensive...Senior
$200k - $275k
...scale our Quality Management System (QMS) as... ...Practice (GCP) compliance across our global... ...Good Manufacturing Practice (GMP) oversight for our... ...Operations, CMC, and external partners, the Director... ...Provide QA oversight of external... ...a leadership or senior management role...SeniorTemporary workFrontier Medicines Corporation
Boston, MA3 days ago$210k - $320k
...delivery and internal manufacturing capabilities. Beam’s suite... ...and regulatory compliance support for the development... ...and BLA/MAA).Plan and manage activities for the... ...preparing and hosting GMP and pre-approval inspections... ...with key internal and external stakeholders....SeniorFull timeShift work3 days per week1 day per weekBeam Therapeutics
Somerville, MA1 day ago$149k - $166k
...information, please visit .Position SummaryThe Senior Manager, Regulatory Operations will plan,... ..., Nonclinical, Clinical, Quality, and external partners to compile, quality-check, and... ...technical standards.Process & Compliance: Maintain regulatory operations SOPs and...SeniorFull timeTemporary workPrime Medicine
Somerville, MA4 days ago$65 per hour
...Description The Sr. Specialist GMP QA Operations works with a high... ...of their function. The Senior Specialist completes work in... ...alignment with corporate goals and compliance with all regulatory... ...as batch review release CMO - external vendors in a commercial drug...SeniorFull timeContract workTemporary work$60 - $80 per hour
...Title: Quality Assurance Manager Job Description... ...for biologics manufacturing, with a strong focus on... ...internal manufacturing and external contract manufacturing... ...key role in ensuring GMP compliance, maintaining a strong... ...in quality assurance (QA) and quality control (...Full timeContract workTemporary workMonday to FridayActalent
Lexington, MA1 day ago$155k - $165k
...considered. SUMMARY The Senior Manager, Lentiviral Vector (LVV) Manufacturing will provide hands‑on... ...operational leadership for GMP lentiviral vector... ...completeness, and GMP compliance to drive right‑first‑time... ...meetings, internally and externally. Foster a culture of accountability...SeniorFull timeContract workWork at officeFlexible hours3 days per week$120k - $200k
The Opportunity:As the Senior Associate/Associate Director of Portfolio and Strategy Operations... ...help steer content for leadership and external KOL meetings.You are someone who has the... ...Team and Board.You are critical to the management and maintenance of the project long-...SeniorFlexible hoursRelay Therapeutics
Somerville, MA4 days ago$161.5k - $242.3k
...GxP Operations Support Manufacturing Systems will provide... ...also support lifecycle management of manufacturing systems... ...Skills:Quality and Compliance:Support and oversee validation... ...including GMP, GAMP, Data Integrity,... ...seek talent who bring an external perspective, demonstrate...Full timeSummer workFlexible hoursVertex Pharmaceuticals
Boston, MA17 hours ago- ...QA Manager Gives direction and manages all quality assurance functions... ...assure the site operates in compliance with regulatory and... ...validation, change control, manufacturing discrepancy investigations,... ...department in internal and external meetings. Assumes responsibilities...Work experience placementWork at office
Fagron
Canton, MA1 day ago $190.8k - $300.3k
Job DescriptionDescriptionThe Senior Director (Sr. Principal... ...agencies.You will independently manage projects, functioning as the... ...indications, formulations, or external partners. Prior experience in... ...conviction records for employment in compliance with the San Francisco Fair...SeniorFull timeFor contractorsLocal areaWorldwideFlexible hoursMerck Sharp & Dohme (MSD)
Boston, MA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior GMP QA Manager: External Manufacturing & Compliance. Be the first to apply!
Related searches
- production manager food manufacturing Cambridge, MA
- manufacturing operations manager Cambridge, MA
- area production manager Cambridge, MA
- industrial production manager Cambridge, MA
- director manufacturing science and technology Cambridge, MA
- director manufacturing Cambridge, MA
- manufacturing production manager Cambridge, MA
- production planning manager Cambridge, MA
- production control manager Cambridge, MA
- manufacturing manager Cambridge, MA