QA Operations Lead: External Manufacturing & Compliance
Genetix Biotherapeutics
Genetix Biotherapeutics seeks an Associate Manager, Quality Assurance Operations to provide QA oversight of external manufacturing partners, ensuring cGMP compliance and Genetix quality standards. You will partner with Manufacturing, MS&T, Quality Control, and Patient Supply teams and CMOs to govern deviation management, change controls, and quality system reviews. The role requires 4–6 years in QA within GMP biopharma or cell/gene therapy, plus a Bachelor’s in Life Sciences (advanced degree #J-18808-Ljbffr Genetix Biotherapeutics
- ...Biotherapeutics in Somerville, MA is seeking an Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure cGMP compliance. You will serve as a QA liaison across Manufacturing, MS&T, Quality Control, and CMOs, managing deviations...SuggestedFull time
- Mariana Oncology is seeking a Senior QA Specialist for Radioligand GMP Manufacturing Operations. The role focuses on ensuring compliance with quality standards in the production of... ...radiopharmaceuticals, supporting QA activities, and leading investigations. The ideal candidate...Suggested
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...Description Summary:Our Operations division is hiring an... ...Program Manager will lead cross-functional operations... ...and execution, drive manufacturing readiness, identify... ...to internal and external stakeholders.Skills and... ...Union ranges will be in compliance with the collective bargaining...SuggestedFull timeContract workWork at officeLocal area- ...Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee deviations,... ..., ensuring inspection readiness and regulatory compliance across shifts while partnering with...SuggestedShift work
$210k - $320k
...committed to establishing the leading, fully integrated platform... ...editing, delivery and internal manufacturing capabilities. Beam’s suite... ..., and phase-appropriate compliance standards.Collaborate closely... ...quantitation, cell-based assays.External CDMO alliance management...SuggestedFull time- ...to provide strategic and operational QA oversight across drug development, manufacturing, and commercialization. You will lead scalable QMS and... ...Supply Chain, and ensure compliance with global regulations... ...-functional leadership, external partner oversight, and a...
$146k - $194k
...by Lattice OS, an AI-powered operating system that turns thousands... ...maritime vehicle and flexible manufacturing architecture that scales... ...looking for a Division Operations Lead to join our rapidly growing... ...provider helps to ensure compliance with applicable laws and protect...Full timeWork experience placementWork at officeImmediate startFlexible hours$133.8k - $200.6k
...DescriptionGeneral SummaryThe Operational Area Quality Senior... ...for assembly manufacturing operations supporting... ...quality, and regulatory compliance while partnering with... ..., supply chain, and external manufacturing... ...manufacturing documentation.Lead and approve manufacturing...Full timeContract workSummer workRemote workFlexible hours2 days per week$175k - $238.88k
...opportunity to grow. Join us!The Director of Operations leads all manufacturing operations at the Newton site (all... ...all internal business units and external customers.Partner with Operations,... ...EHS excellence and regulatory compliance.Support audit readiness and quality...$176.6k - $294.3k
ROLE SUMMARYThe US MA Business Operations Lead, Obesity is a key member of the US Medical Business... ...monitor efficiency, effectiveness & compliance.Independently lead implementation of... ...objectives both internally and externally.Lead / Co-lead strategic initiatives focused...Permanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package$218.4k - $327.6k
...Summary:The Senior Director, Business Operations Lead is a senior role within the Business Operations... ...function supporting Commercial Manufacturing and Technical Operations (CMTO).... ...experience supporting manufacturing, external manufacturing, CDMO management, or technical...Full timeContract workSummer workRemote workFlexible hours2 days per week$115k - $125k
...Manager, Quality Assurance Operations will provide quality oversight of external manufacturing partners to ensure compliance with cGMP requirements,... ...: Provide on-call QA support for manufacturing... ...oversight model, including leading QA-to-QA forums and guiding...Full timeWork at officeFlexible hours3 days per week$167k - $300.7k
...Executive Director of Digital Operations and Strategic... ...Finance, Operations, and external partners to enable... ..., and execution plans.Lead planning and governance... ...Embed security, privacy, compliance, and audit-ready... ...within pharmaceutical CMC, manufacturing, quality, supply chain...Permanent employmentFull timeWork at officeWork from homeShift work- ...Boston is seeking a part-time, hands-on Operations Manager with strong bookkeeping... ...and office services. Interact with external service providers (e.g., IT support, HR... ...systems. Oversee insurance renewals, compliance documentation, and coordination with external...Full timeContract workPart timeWork at officeWork from homeFlexible hours3 days per week
$107.5k - $204.5k
...problems. With our three market leading businesses, world-class operations and investments in research and development... ...Office (PMO) in leading manufacturing strategy for programs in development... ...and Protected Veterans in compliance with Section 503 of the Rehabilitation...Contract workTemporary workWork experience placementRemote workWorldwideRelocation packageFlexible hours- ...Cambridge, MA is seeking a Biomarker Operations Manager to support biomarker... ...trials, as well as with external biorepositories, assay laboratories and CROs. You will lead the development and execution... ...lifecycle, ensure GCP/ICH compliance, and drive process improvements...
- ...and coordinate communications among the Board, departments, and external parties. The role requires managing applications, fees,... ...records; preparing reports, agendas, and notices; and ensuring compliance with procedures and regulations in a #J-18808-Ljbffr Kinsley...
- Jobtailor is seeking a manufacturing supervisor to lead daily machining operations, ensuring production schedules, quality standards, and timely delivery. You... ...and Operations to resolve issues, while ensuring compliance with FDA QSRs and ISO standards. Excellent communication...
$116k - $182.27k
...PURPOSE: Responsible for operational leadership to ensure... ...organization ACCOUNTABILITIES: Lead operational activities... ...relationships with key external partners and vendors... ...Medical affairs, Global manufacturing services, Ethics and Compliance) Strong proven ability...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift- ...Cambridge, MA, is seeking a Biomarker Operations Manager to support biomarker and clinical... ...its clinical trials, and to work with external biorepositories, assay laboratories and... ...therapeutic area teams to ensure implementation, compliance and support of biosample plans and...
- Position Summary We're looking for an HR Operations Lead to own and run the people... ...HR programs end to end - from HRIS and compliance to benefits and employee relations - and... ...and serve as the internal partner to our external broker, including employee education and...Work from homeFlexible hours
$162k - $223k
About This RoleThe Strategy & Operations (S&O) Lead is a strategic partner within Biogen, who will take a lead role in owning and managing critical... ...sharing with different levels of the organization and / or externally.Responsible for ensuring US Medical stays on track to...Full timeTemporary workLocal areaWorldwide$135k - $150k
...discover, develop, manufacture, and commercialize... ..., where you can operate at the forefront of... ...is to advance our lead in vivo development... ...part of a small QA team with opportunities... ..., and compliance. Support the management... ...Additional factors such as external market conditions,...Flexible hours$171.5k - $207.5k
...tomorrow. Emergent is a leading public health... ...Assurance Operations provides senior leadership... ...Drug Substance manufacturing site, ensuring... ...accountable for real time QA oversight of... ...closely with QA Compliance and Supplier... ...supports internal and external projects,...Local area$153.9k - $230.9k
...application of quality assurance and compliance. The Associate Director... ...and oversight for manufacturing operations conducted across assigned shifts... ...The Associate Director also leads and develops a team of quality... ...OversightProvide shift-based QA oversight for aseptic...Full timeSummer workFlexible hoursShift work$199k - $274k
## Director, Strategy & Operations and Congress Strategy Lead, U.S. SYFOVREApplylocations: US - Walthamtime... ...Commercial Operations, Analytics, Finance, Compliance, and other key partners, while... ..., Compliance, Operations, and external agencies/vendors to deliver a coordinated...Summer workWork at officeLocal areaFlexible hours3 days per week$88.5k - $147.5k
...Medicine team, you will support vivarium operations by managing an assigned portion of the... ...environment and operational processes are in compliance with local and federal regulations and... ....Other Job Details As needed, Ops team lead may need to work on weekends.Relocation...Permanent employmentFull timeH1bWork at officeLocal areaRemote workVisa sponsorshipWork visaRelocation packageWeekend work$90k - $180k
...with those of our clients.About the RoleThe PositionThe HR Operations Team Lead would serve as the operational backbone of our human resources... ...defined and consistently executed; and HR records are in compliance with applicable laws or guidelines.Enables HR Digital...Full timeRemote workFlexible hours1 day per week- ...looking for an Associate Director in Boston to oversee Quality Assurance Manufacturing Technical Services. This role includes managing quality operations for Cell & Gene Programs and ensuring compliance with regulatory standards. The candidate should hold a Bachelor’s in...
$252.3k - $378.5k
## Executive Director, Manufacturing Operations - T1DApplylocations: Boston, MAtime type: Full... ...on this mission by building and leading a global external manufacturing network for our Type... ...disciplined planning and executionQuality & Compliance* Champion Vertex’s commitment to...Contract workSummer workRemote workFlexible hours2 days per week
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