Head of Quality Control, Gene Therapy (On-Site)
Beam Therapeutics
Beam Therapeutics is seeking an Associate Director, Quality Control to lead the Massachusetts QC team and ensure compliant GMP testing for clinical and late-stage programs. This on-site role oversees release, stability, method qualification/validation, and transfers, while maintaining inspection readiness across methods, equipment, data systems, and documentation. The candidate will guide deviations, investigations, CAPAs, and effectiveness checks, partnering with QA, Manufacturing, and #J-18808-Ljbffr Beam Therapeutics
$275k - $315k
...potential first‑in‑class oral therapy, VE303, in a Phase 3 trial for... ...is looking for an experienced Head of Quality to lead the Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance... ...directly supporting on‑site production, including responsibility...WebsiteContract workTemporary work- ...defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating model, and... ...capabilities across internal manufacturing sites and external partner networks. The position... ...experience across GXP life cycle in Cell & Gene therapy and/or Biologics.Broad and deep...WebsiteFull timeSummer workFlexible hours
$148k - $222k
## Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)Applylocations: Boston, MAtime type: Full... ...strategies to be deployed at the local site level and monitored for... ..., and improvement including change control, events, CAPA, escalation, and risk...WebsiteSummer workLocal areaRemote workFlexible hours2 days per week- ...the high-velocity, high-quality, data-driven... ...required to get life-saving therapies to patients faster. Dash... ...technically forward-thinking Head of Quality to serve as... ...for quality across all site operations, laboratory... ...the laboratory: Document control, CAPA, deviation...WebsiteFull time
- Ultragenyx Pharmaceutical in Bedford, MA seeks a Quality Assurance Drug Substance (DS) Specialist to oversee QA activities for a gene therapy manufacturing site. You will review batch records, perform deviations management, and collaborate across Manufacturing, Engineering...Website
- Vertex is seeking a Gene Therapy Account Manager (GTAM) to lead primary account management for Activated Treatment Centers supporting SCD... ..., and operational readiness to enable Casgevy across assigned sites. The candidate will collaborate with cross-functional teams, maintain...Website
- Ultragenyx Gene Therapy in Bedford, MA is seeking a Senior Specialist, Quality Assurance Operations to oversee QA activities for drug substance manufacturing at a new... ...ensure GMP compliance and timely investigations. On-site, four 10-hour days with a 7:00-8:30 start. #J-18...Website
$190k - $230k
...Director/Director, Technical Quality – Solid Biosciences Charlestown... ...on advancing a portfolio of gene therapy candidates targeting rare... ...documentation (batch records, change controls, deviations, etc.) to assess... ...tech transfer from one site to another including...WebsiteTemporary workRemote workFlexible hours$115k - $125k
...company that’s pursuing curative gene therapies to give patients and their... ...The Associate Manager, Quality Assurance Operations will provide... ...Manufacturing, MS&T, Quality Control, and Patient Supply) and CMOs... ...Massachusetts headquarters, with on-site presence expected (three)...WebsiteFull timeWork at officeFlexible hours3 days per week- ...medicines for people with serious diseases. We are currently seeking a Gene Therapy Account Manager (GTAM) to support our Sickle Cell Disease (SCD)... ...readiness across patient services, reimbursement pathways, and site operations both during and after activation.Coordinate Vertex...WebsiteFull timeSummer work
$205k - $327.6k
Job TitleHead of Quality, Ambulatory Monitoring & DiagnosticsJob DescriptionHead of Quality... ..., Ambulatory Monitoring & DiagnosticsThe Head of Quality, Ambulatory Monitoring &... ...the AM&D business, teams, and associated sites. This leader serves as a driving force in...WebsiteFull timeWork at officeImmediate startWork visa3 days per week$212k - $318k
...multiple breakthrough medicines for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx, a... ...401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role,...WebsiteFull timeSummer workRemote workFlexible hours2 days per week$198k - $297k
...laboratory technology platforms across LC1/2, Vertex's Cell & Gene Therapy (CGT) site. It is also the single accountable Research Site Partner... ...sustain strong, trust-based relationships with senior business, quality, and DTE leaders, acting as a strategic partner with...WebsiteFull timeSummer workLocal areaRemote workFlexible hours2 days per week$210k - $300k
..., Analytical Development and Quality Control, you will provide strategic and... ...& GMP OversightAct as Head of Quality Control for analytical... ...across internal and external sites.Establish and manage budgets,... ...patients and developing novel therapies for other rare neuroendocrine...WebsiteContract workWork at office$90.4k - $135.6k
...lethality to discover and develop therapies that take aim at critical... ...such as tumor suppressor gene loss and their contribution to... ...internally and at external clinical sites, contract laboratories, and... ...(CROs).Oversee compilation, quality control, and integration of...WebsiteContract work$180.8k - $271.2k
...The Senior Director, CGT Quality Systems, Personalized... ...medicine and advanced cell therapies across the patient... ...investigations, change controls, risk assessments, CAPA... ...lifecycle for cell and gene therapy, biologics, and... ...Hybrid-Eligible Or On-Site Eligible Flex Eligibility...WebsiteSummer workRemote workFlexible hours2 days per week$153.9k - $230.9k
...SummaryThe Associate Director - Shift Quality Operationsis an advanced... ...assigned shifts for cell therapy manufacturing. This role is responsible... ...processing requirements, site quality systems, and... ...Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation...WebsiteFull timeSummer workFlexible hoursShift work- ...Vertex Pharmaceuticals seeks an Associate Director, Analytical Quality Assurance to oversee QC and analytical development activities across Cell & Gene programs. You will drive QA oversight of method validations, transfers, and stability programs, while leading audits...WebsiteContract work
$148k - $222k
...design and tactical execution of quality systems, risk management, and... ...across Vertex Cell and Gene Therapy (VCGT); partners with cross-functional... ...strategies (local site deployment and governance), collaborate... ...and improvement (change control, events, CAPA, escalation,...WebsiteLocal area$226.1k - $339.1k
...leadership role within the Cell and Gene Therapy Analytical Development... ...operations such as reagent and assay control management.The role will work... ...Development, Regulatory, Quality, CMC, and external partners... ...more.Flex Designation:On-Site DesignatedFlex Eligibility Status...WebsiteFull timeSummer workFlexible hours$137.8k - $206.8k
...Summary:The Senior Manager, Clinical Study Quality Lead provides study-level quality... ...including CROs, vendors, and investigator sites, to support quality outcomes across Vertex... ...devices, combination products, or cell and gene therapy clinical trials.Experience supporting...WebsiteFull timeSummer workRemote workFlexible hours2 days per week$171.2k - $256.8k
...lethality to discover and develop therapies that take aim at critical... ...areas such as tumor suppressor gene loss and their contribution to... ...reporting to the Executive Director, Quality, is responsible for leading... ...GCP audit strategy (CROs, sites, vendors, systems, and processes...WebsiteContract work$58k - $123.2k
...organization, with a primary focus on CNS gene therapy biodistribution and molecular... ...scientific standards, timelines, and data‑quality expectations. Data Analysis, Visualization... ...Lilly location, and requires daily, on‑site presence and lab work. About Eli Lilly’...WebsiteFull timeFixed term contractH1bVisa sponsorshipWork visaFlexible hours$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is... ...Conducts directed or for cause audits and site inspection preparation visits as... ...transition to clinical studies or Cell and Gene Therapy is advantageous.Professional clinical trial...WebsiteFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$145k - $196k
...you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are... ...Assembly Row, Massachusetts office. The Sr. Manager, Quality Assurance for Quality Control manages contract testing organizations (CTOs) for all...Full timeContract workWork at officeFlexible hours3 days per week- Vertex Pharmaceuticals, a leader in cell & gene therapy, seeks a Senior Manager QA for QC to oversee analytical quality across development and transfer activities. You will... ...for OOS/OOT, review containment and change controls, and promote a data-driven, AI-enabled quality...
- ...focused on developing transformative gene-based medicines for serious human... ...]), the world’s first CRISPR-based therapy, approved for eligible patients with... ...for updating, maintaining and quality control of the eTMF, SharePoint site and shared drive Responsible for...WebsiteRemote workFlexible hours
$206k - $257.5k
...diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're... ...manner Familiarity with external control arms, real-world evidence, or... ...hybrid, you will be expected to work on site at one of Sarepta's facilities in the...WebsiteFor contractors$185k - $225k
...assembled a platform with integrated gene editing, delivery and... ...seeking an Associate Director, Quality Control to lead the Beam... ...inspection readiness. This on-site role will provide site-based... ...Control within biologics, cell therapy, gene therapy, mRNA, or other...WebsiteFull time$156.6k - $234.8k
...Manufacturing Process & Technical Quality Associate Director provides... ...oversight for cell and gene therapy programs across clinical development... ..., deviations, change controls, risk assessments, and compliance... ...Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility...WebsiteFull timeContract workSummer workRemote workFlexible hours2 days per week
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