External QA Lead, GMP Operations (Hybrid)
Vertex Pharmaceuticals Inc (US)
Vertex Pharmaceuticals is seeking an Associate Director, Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, from development through commercial execution. You will partner with internal and external teams to ensure compliant, reliable operations and a robust Quality Culture. The role leads the QA oversight model, manages deviations and CAPAs, drives digitization, and ensures GMP compliance across quantity processes.
#J-18808-Ljbffr- ...Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure... ...improvements. The role demands 4–6 years in QA within GMP biopharma, strong regulatory... ..., matrixed environment with on-site/hybrid flexibility at Somerville, MA. #J-...Operations
$94.6k - $141.8k
...Associate Director, GMP Operational QualityApplylocations:... ...complex programs. This role leads day-to-day quality... ...direction in support of external drug substance... ...quality initiatives and QA oversight of external... .... Flex Designation: Hybrid-Eligible Or On-Site Eligible...OperationsContract workSummer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate...Suggested
- ...Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across... ...staff on GCP, and support audits and inspections. The role involves hybrid work with 2 onsite days weekly at Mass General Hospital and...Suggested
$156.6k - $234.8k
...Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across... ...also include inclusive market-leading benefits to meet our employees... ...much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible...OperationsSummer workRemote workFlexible hours2 days per week- ...Vertex Pharmaceuticals seeks an Associate Director, Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical...Operations
$150k - $180k
...Quality Assurance Program Lead Title: Quality... ...Lead Location: Boston (Hybrid) with travel to project... ...~ Develop the QA Program Manual and user... ...Procurement, and with external partners, including our... ...~ Reports to: VP of Operations, with direct access to...OperationsRemote jobFull timeFor contractors- Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits... ...degree, and strong leadership and communication skills. Hybrid onsite/remote work is available at MGH facilities. #J-18808-Ljbffr...Remote work
$200k - $275k
...Quality Assurance to lead and scale our Quality... ...Manufacturing Practice (GMP) oversight for our drug... ...with Clinical Operations, CMC, and external partners, the Director... ...Study Reports Provide QA oversight of external... ...environment that calls for a hybrid hands-on and high-...OperationsTemporary work$116k - $174k
...to the Director of Quality and operate across departments, supporting... ...Assurance, will provide GMP QA oversight for Tango’s CMC development... ...Operations, Regulatory, and external manufacturing partners to ensure... ...for use in clinical trials Lead & manage strategic GMP QA activities...OperationsContract work$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and... ...closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company... ...Generate and its external partners. Lead Generate’s CMC Quality relationships...OperationsContract workFor contractorsShift work- ...Vertex is seeking a GMP Operational Quality Senior Specialist in Boston to support quality assurance and regulatory compliance across investigations, CAPA, and change control. The role emphasizes root-cause analysis, product impact assessments, and collaboration with cross...Operations
$147.5k - $221.3k
...readiness and compliance of external sites including evaluating, improving... ...programs for external operations. Works cross-functionally and... ...sigma or leanProven ability to lead improvement projects and... ...international travel possible Hybrid-Eligible RolesIn this Hybrid-...OperationsFull timeSummer workRemote workFlexible hours2 days per week$184.6k - $277k
...and compliance of internal and external sites including evaluating,... ...associated governance across all GMP areas. This position focuses... ...skills with proven ability to lead teamsEducation and Experience:... ...10% Travel may be required#LI-hybrid #LI-JS1At Vertex, we embrace continuous...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...Location: Cambridge, MA (Hybrid) Overview An innovative... ...phase-appropriate GMP compliance across a growing... ...Build and lead a high-performing QC organization... ...as programs advance. QC Operations & Laboratory Management... ...MSAT, Regulatory, and External Manufacturing teams to...Operations
$156.6k - $234.8k
...The Associate Director, GMP Operational Quality is responsible... ...Duties and Responsibilities:Lead a Quality team:... ...VertexCollaborate with internal and external business partners to... ...activitiesOversee the QA support of Change... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...events/ non-conformances encountered during GMP operations, such as manufacturing, testing or... ...and guidance in responding to deviations. Lead investigation teams. • Make recommendations... ....• Provide support during internal and external audits and ensure that assigned audit...OperationsImmediate start
$227.9k - $308.3k
...Pharmacovigilance Quality Assurance Lead provides executive leadership... ...direction for the GVP QA function and provides independent... ...to support sustainable growth, operational excellence, and long-term... ..., MA or Philadelphia, PA in a hybrid work arrangement, or remotely...OperationsFull timeTemporary workLocal areaRemote workFlexible hours- ...Quality Assurance to support External and CMC Quality Assurance. This... ...service providers. Provide QA oversight of deviations,... ...inspection readiness across outsourced operations and support health authority... ...~ Strong working knowledge of GMP/GxP requirements, FDA/EMA...OperationsContract work
$160.6k - $240.8k
...Summary:The Clinical Study Quality Lead (SQL), Associate Director is... ...oversight of clinical trial operations and applicable vendors,... ...and in writing to internal and external customersExcellent organizational... ...much more.Flex Designation:Hybrid-Eligible Or On-Site...OperationsFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$115k - $125k
...This is a full-time hybrid position (3 days a... ...Quality Assurance Operations will provide quality oversight of external manufacturing partners... ...Provide on-call QA support for manufacturing... ...model, including leading QA-to-QA forums and... ...Assurance within GMP-regulated...OperationsFull timeWork at officeFlexible hours3 days per week$112.1k - $154.2k
...CD PROJEKT RED is looking for a QA Lead to join the Cyberpunk 2 team in our Boston this... ...Partner with development production and external QA vendors to coordinate dependencies gameplay... ...US. Working mode: in-office in a hybrid or full-time capacity. As part of our...Full timeCasual workWork at officeRemote workHome officeFlexible hoursShift work- ...across a dynamic global business. This hybrid Boston role goes beyond calendar management... ...environment. The role manages exec operations, coordinates priorities, and facilitates... ...communication with senior leadership and external partners. Strong relationship management...Operations
$184.6k - $277k
...SUMMARY:The Quality Operations Director provides... ...portfolios. The Director leads a risk-based... ...other internal and external stakeholders.KEY DUTIES... ...with senior Vertex QA leadership on... ...professionals in a complex GMP environmentProven... ....Flex Designation:Hybrid-Eligible Or On-Site...OperationsFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$170k - $210k
...National Program Manager, Air Quality to lead and expand our national air quality program... ...leadership, business development, and operational oversight for Tetra Tech's national air quality... ...consulting.Location: Flexible (Remote/Hybrid; Travel Required)Why Tetra Tech:At Tetra...OperationsContract workFor contractorsWork experience placementWork at officeLocal areaRemote workWorldwideFlexible hours- ...experienced Event Manager for a temporary role. You will partner with internal teams to plan and execute internal and external events across virtual, hybrid, and in-person formats. The ideal candidate will have several years of event management, meeting planning, or...OperationsTemporary work
$115k
...You are a hands-on accounting operations leader who brings strong... ...functions. You are comfortable leading teams, improving controls, solving... ..., GAAP, and internal and external audit requirements. Develop and... ...similar industry LOCATION: Hybrid - Boston Candidate must reside...OperationsFull timeWork at officeRemote workRelocation- ...Trust Center for MIT Entrepreneurship seeks an Operations and Events Assistant to provide front-line... ...management, including coordinating with MIT IS&T and external vendors. The position is designed as a temporary-to-permanent, hybrid role with a blend of on-campus work and...OperationsPermanent employmentTemporary workRemote work
- ...ChemicalCompound Manager for an opportunity near Cambridge, MA. The role is hybrid, requiring 2-3 days onsite, and is a 12‑month contract with... ..., maintain inventory and SOPs, and coordinate with CROs and external collaborators. Strong knowledge of registration platforms and...OperationsContract work
$161.5k - $232k
...Associate Director or Director, GMP Quality Assurance is... ...and reports Perform QA review of executed batch... ...Agreements, ensuring external partners meet GMP expectations... ...-making Ability to lead investigations and write... ...metro areas, with a hybrid model requiring 3 days per...Work at officeLocal areaRelocation3 days per week
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