Associate Director, GMP Quality CGT Personalized Medicine
$148k - $222kScorpion Therapeutics
Position Summary Supports strategic design and tactical execution of quality systems, risk management, and quality culture across Vertex Cell and Gene Therapy (VCGT); partners with cross-functional technical development and commercial teams to harmonize Quality Management System (QMS) strategy, procedures, and processes and drive quality improvements. Key Duties & Responsibilities Process lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA): lead oversight, ensure on-time execution per procedures/regulatory requirements, and monitor/support CGT quality risk management items; identify and implement continuous improvement projects. Process lead for VCGT Data Integrity (DI) program: define DI compliance operational strategies (local site deployment and governance), collaborate with global process owner on DI continuous improvement. Provide local quality system oversight and improvement (change control, events, CAPA, escalation, risk management) and lead monitoring/interpretation/communication of QMS processes and metrics, including remediation plans. Resolve complex quality issues with internal/external partners; provide hands-on expertise managing GxP data collection systems and controls using digital solutions. Support strategic risk management monitoring, DI initiatives, internal/external audits, and enhance quality culture. Provide project management leadership for department initiatives. Required Education Bachelor’s degree in a scientific discipline, operations research/management, business administration, or related field. Required Experience 10+ years (or equivalent combination of education/experience); product life cycle experience from discovery to commercial development. Required Knowledge/Skills Deep expertise in global GMP regulations/guidances and GxP QMS; strong leadership and cross-functional collaboration; assess cross-procedure/system impact; lead complex projects/teams; project management proficiency; strong technical writing/presentation/communication; influence/coaching skills; lead improvement projects; investigate/root-cause analysis and CAPA. Other Requirements Up to 15% travel. Pay Range $148,000 - $222,000 #J-18808-Ljbffr Scorpion Therapeutics
- Scorpion Therapeutics is seeking a senior Quality leader to design and execute robust quality systems across programs. You will align QMS strategy with cross-functional teams to drive improvements and ensure regulatory compliance. You will oversee APQR/QPQA, data integrity...Suggested
- Vertex Inc. is seeking a Senior Director of CGT Quality Systems to provide strategic quality leadership for personalized medicine and advanced cell therapies across the patient journey. The role partners with Global Quality, Manufacturing, MS&T, Regulatory, Commercial,...Suggested
$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel... ...expectations, planning, coaching, training and developing personal growth opportunities through IDPs.Accountable to...SuggestedFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$94.6k - $141.8k
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Job Description General/Position Summary The Senior Director, CGT Quality Systems, Personalized Medicine provides strategic Quality leadership for personalized... ...the end to end patient CGT treatment journey assuring GMP requests are assessed, governed, documented,...SuggestedSummer workRemote workFlexible hours2 days per week$172k - $202k
...establishing a new class of medicines that engage... ...resourceful, and enthusiastic quality control lead excited... ...also support CDMO on GMP commercial manufacturing... ...and developing associated limits/specifications.... ...otherwise process, your Personal Information. Please reference...Work at officeLocal areaRemote work1 day per week$160k - $180k
...your career, and for what’s beyond About the Role As the Associate Director, GMP Quality , reporting to the Head of GMP Quality , you will be responsible... ..., review of Certificate of Analysis, Batch Disposition, Person in Plant oversight, and supporting Supplier compliance....Work experience placementWork at officeFlexible hours$180k - $195k
Associate Director, Quality Assurance - CMC Seaport Therapeutics is a clinical-stage... ...of novel neuropsychiatric medicines in areas of high unmet... ...Quality Assurance CMC to manage GMP quality assurance... ...Motivated by patient focus and personal commitment to high performance...$160k - $180k
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The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital... ...requires strong expertise in GMP laboratory automation,... ...infrastructure to reimagine how medicines are created and delivered,... ...have always believed an in-person culture is critical to our...Permanent employmentFull timeWork at officeWork from home$185k - $225k
...integrated platform for precision genetic medicines. To achieve this vision, Beam has... ...diseases.Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts... ..., scientifically sound, and timely GMP testing while maintaining a continuous...Full time- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or...
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...Job Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences Charlestown,... ...Biosciences is a precision genetic medicine company focused on advancing a... ...transfer of processes and analytics, CDMO GMP manufacture, CTL testing, and...Temporary workRemote workFlexible hoursSolid Biosciences
Charlestown, MA8 days ago- Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality in Boston to oversee team activities and ensure quality deliverables within department purview. The role requires comprehensive knowledge of quality assurance and compliance principles. You...
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...may ultimately limit the number of new medicines that can reach patients, Formation Bio... .... About the Position The Digital Quality Associate Director/Director is a critical member of the Quality... ...(e.g., ALCOA+) and applicable GMP, GCP, and/or GLP regulations as they pertain...Work at officeLocal area3 days per week$160.6k - $240.8k
Job DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical... ...employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age,...Full timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$145.6k - $218.4k
...General Summary: As the Associate Director of Strategic... ...and Gene Therapy (CGT) Raw Materials, you... ...regulations, quality expectations, capacity... ...Manufacturing Practices (GMP) and ISO standards... ...regard to a person's race, color, sex... ...transformative medicines for people with serious...Long term contractContract workSummer workWork at officeRemote workFlexible hours2 days per week$160k - $200k
Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible for providing hands-on-Quality Operations oversight for GMP manufacturing activities supporting clinical programs. This...Work at officeRemote work$148k - $222k
## Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)Applylocations: Boston, MAtime type... ...management program items associated with CGT. Identify and implement continuous... ...*** Broad and deep expertise in global GMP regulations, guidances, and Quality Management...Summer workLocal areaRemote workFlexible hours2 days per week$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be... ...preferred.At least 10 years of GMP and Quality experience,... ...+ 3 paid days off for Personal Significance 80 hours of sick... ...to deliver life-changing medicines, with every role playing a...Full timeTemporary workLocal area- Xenon Pharmaceuticals invites an experienced Associate Director to lead Quality Control activities across DS/DP programs in line with ICH and cGMP. The role requires managing analytical testing, stability programs, investigations, and collaboration with QA and external...Remote work
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Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and...Temporary workLocal areaRelocation package- A leading global pharmaceutical company is seeking an Associate Director for Clinical & Quality Process Compliance. This role involves ensuring high-quality standards across processes and compliance with regulatory requirements. The ideal candidate will have significant...
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...establishing a new class of medicines that engage... ...formulation, development, and GMP manufacturing. If you... ....The OpportunityThe Associate Director, Drug Product Development... ...execution, ensure quality, and deliver timely technical... ...contributions each person brings. We believe...Work at office2 days per week3 days per week$71.25k - $161.7k
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