Associate Director, GMP QA & Global Validation
Vertex Pharmaceuticals
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 measures, and CAPA processes, while aligning with corporate strategies and timelines.
Independent leadership of cross-functional teams, collaboration with external sites, and ongoing process improvements are required to ensure
#J-18808-Ljbffr$159.8k - $239.8k
Job DescriptionThe Associate Director of GMP Operational Quality Assurance is an... ...for oversight of multiple Validation projects associated with Product... ...compliance with relevant global regulatory requirements.... ...goods GMP operationsServe as QA assessor/approver: resolve...SuggestedFull timeContract workWork experience placementSummer work$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality... ...biologics pharmaceutical setting, including global GMP manufacturing... ...leadership of complex quality initiatives and QA oversight of external manufacturing operationsAt...SuggestedFull timeContract workSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight... ...to support GMP activitiesOversee the QA support of Change Controls, GMP... ...pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...Pharmaceuticals, Inc. is seeking an Associate Director of Quality Control to lead... ...inspection readiness, global compliance, and collaboration... ...Manufacturing, Regulatory Affairs, and QA to ensure timely commercial... ..., strong knowledge of GMP and regulatory expectations,...Suggested
- Beam Therapeutics Inc. seeks an Associate Director of Product Quality Assurance... ...quality oversight of GMP operations, including internal... ...will oversee analytical method validation, vendor relationships, and ensure compliance with global cGMP standards #J-18808-Ljbffr...Suggested
$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence... ...; advanced degree (MS/PhD) preferred.At least 10 years of GMP and Quality experience, including 5+ years leading QRM and/...Full timeTemporary workLocal area- ...Vertex Pharmaceuticals Incorporated is seeking an Associate Director, GMP Operational Quality to oversee a Quality team, ensure compliant GMP activities... ...will coordinate with internal and external partners, manage QA for change controls, investigations, and CAPAs, and support...
$154.4k - $242.55k
...company to inspire you and empower you to shine? Join us as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge,... ..., and cross-functional stakeholders to identify, validate, and implement biomarkers relevant to patients in clinical...Minimum wageLocal area$185k - $225k
...Position Overview:We are seeking an Associate Director, Quality Control to lead the... ...sound, and timely GMP testing while maintaining a continuous... ..., method qualification/validation, and method transfer testing... ...Serve as a key QC interface with QA, Manufacturing, MS&T,...Full time$156.6k - $234.8k
...Process & Technical Quality Associate Director provides end-to-end l quality... ...medicine requirements.Lead QA review and approval of stage... ...technology transfers, process validations, and new product... ...lifecycleKnowledge and Skills:In-depth global regulatory agency and...Full timeContract workSummer workRemote workFlexible hours2 days per week$185k - $225k
...diseases.Position Overview:The Associate Director of Product Quality Assurance... ...and method qualification/validation is also in scope. Additionally... ...aspects of Quality support for GMP operations. Quality oversight... ...managing CDMOs as well as internal QA systems in a virtual...Full timeContract workWorldwide$158.8k - $238.2k
...DescriptionGeneral Summary:The Associate Director, QC Technical Services -... ...services group responsible for GMP release and stability... ...Experience in method development, validation, and transfer of non-... ...HybridCompany InformationVertex is a global biotechnology company that...Full timeContract workSummer workRemote workFlexible hours2 days per week$180k - $195k
...Associate Director, Quality Assurance CMCBoston, MASeaport Therapeutics is a... ...strategy of advancing clinically validated mechanisms previously held... ...Quality Assurance CMC to manage GMP quality assurance activities... ...Key ResponsibilitiesManages QA resources assigned to...- ...Associate Director, Global Regulatory Project Management And Strategic Planning - Oncology TauAt Takeda, we are a forward-looking, world-class R... ...relevant information, analyze data, establish facts and draw valid conclusionsAnalytical and problem-solving skills with the...Remote workWorldwide
$171k - $192k
...expanding and looking to hire an Associate Director of Quality Control reporting... ...an inspection-ready, globally compliant commercial QC team... ...analytical methods, including validation maintenance, transfer, verification... ...supporting commercial GMP products is required....Contract workLocal areaRemote work$156.6k - $234.8k
...Biomarker Operational Quality Associate director provides Biomarker quality... ...activities (fit-for-purpose validations and associated processes) across... ...filings.Conduct Research QA (RQA) review of non-GxP... ...HybridCompany InformationVertex is a global biotechnology company that...Full timeSummer workRemote workFlexible hours2 days per week$169.4k - $266.2k
...vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Scientific Training. This is a hybrid role based in Cambridge, MA....Minimum wageLocal areaRemote work$148.5k - $214.5k
Job title: Associate Director, Global Medical Affairs - DermatologyLocation:Morristown, NJAbout the JobThe Associate Director, Global Medical Affairs - Dermatology will support the development and execution of global medical strategy across the Dermatology portfolio, with...Full timeLocal area$156.6k - $234.8k
...Associate Director overseeing GMP operational quality for cell and genetic therapies at a rare disease-focused pharmaceutical company. Responsible... ...experience ~ In-depth knowledge of cGMP principles and global GMP requirements ~ Demonstrated success building and managing...Work experience placement$153.9k - $230.9k
...General/Position Summary The Associate Director – Shift Quality Operations... ...Control, MSAT, Engineering, Validation, and Supply Chain to support... ...Oversight Provide shift-based QA oversight for aseptic... ...Company Information Vertex is a global biotechnology company that invests...Flexible hoursShift work$161.9k - $242.9k
...Job Description General Summary The Associate Director, Global Pain Forecasting & Analytics will join the Global Forecasting & Analytics team within the Commercial organization to lead forecasting and analytics for Vertex’s global Pain portfolio, spanning current programs...Summer workRemote workFlexible hoursShift work2 days per week$154.4k - $242.55k
...the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction...Minimum wageLocal area$169.4k - $266.2k
...attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAs part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Lung and help advance the organization’...Minimum wageLocal areaRemote work$183k - $252k
About this roleThe Associate Medical Director, Transplant Evidence Generation, is part of the Global Medical Affairs (GMA) Transplant team, a strategic partner within Biogen, that provides medical and scientific expertise across our therapeutic areas and pipeline to improve...Full timeTemporary workLocal area$139.43k - $232.38k
Associate Director, Global Program Management (Oncology)At GSK, we have bold ambitions for patients, aiming to positively impact the health of... ...experienceUnderstanding of drug development and organizational knowledge to validate the operational feasibility, challenge project team...Full timeLocal area- ...Vertex Pharmaceuticals seeks an Associate Director of Logistics Operations to lead end-to-end distribution... ...collaborates with Clinical Operations, QA, CMO scheduling, and commercial teams... ...compliant, efficient product movement globally, with a focus on GDP and trade...
$152k - $209k
...Associate Director, Regulatory StrategyAt Biogen, we are pioneers in neuroscience. The role requires the ability to provide regulatory strategic... ...business objectives. The role may also require review of global, corporate, clinical trial, and pipeline materials and communications...Temporary workWork at office- ...Axtria, Inc. is seeking an Associate Director to lead global teams delivering commercial analytics and sales effectiveness initiatives within the Life Sciences sector. You will partner with clients, design analytics-based solutions, and present executive recommendations...Work at office
$162.8k - $244.2k
## Associate Director, Heme Global Business SystemsApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29345**Job Description****About Vertex:** At Vertex, we are relentless in our pursuit of transformative medicines to improve the...Work experience placementSummer workRemote workWorldwideFlexible hours2 days per week- ...Position Overview Bicara Therapeutics is seeking an Associate Director, Global Scientific Communications, who will lead the development and execution of global scientific communication plans across key assets. This role is responsible for leading the end-to-end tactical...Work at officeLocal area3 days per week
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