QA Analytics Leader, Cell & Gene Compliance (On-Site)
Jobleads-US
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 and CAPA processes to ensure FDA/EMA compliance.
The role emphasizes digital quality systems, data analytics, and collaboration with internal labs and external contract testing labs to maintain robust quality oversight throughout
#J-18808-Ljbffr Jobleads-US$156.6k - $234.8k
...(AD) Quality Assurance (QA for QC) is an advanced technical... ...of quality assurance and compliance. This role is responsible... ...of Quality Control and analytical development activities of Cell & Gene programs. Activities in... ...more.Flex Designation:On-Site DesignatedFlex...WebsiteFull timeContract workSummer workFlexible hours$212k - $318k
...for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx... ..."Strong practical, quantitative and analytical skills combined with a sound... ...Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this...WebsiteFull timeSummer workRemote workFlexible hours2 days per week- ...Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee... ...inspection readiness and regulatory compliance across shifts while partnering... ...experience with quality systems and data analytics to drive continuous improvement...WebsiteShift work
- ...serves as a strategic leader responsible for... ...and executing the Cell & Genetic... ...internal manufacturing sites and external partner... ...programs to meet quality compliance requirements.... ...for process and analytical technical transfers... ...life cycle in Cell & Gene therapy and/or...WebsiteFull timeSummer workFlexible hours
- Vertex Pharmaceuticals is seeking an Associate Director of Quality Systems for Cell & Gene Therapies (VCGT) in Boston. This role partners with cross-functional teams to harmonize QMS strategy, processes and procedures, driving quality improvements across CGT programs. The...Suggested
$240k - $360k
...Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia... ...solving mindset backed by strong analytical skills. The candidate must... ...the next generation of leaders.They will also manage two... ...Designation: Hybrid-Eligible Or On-Site Eligible #LI-Hybrid Flex...WebsiteRemote workWorldwideFlexible hours2 days per week$268.2k - $402.2k
...Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington... ...will serve as a seasoned regulatory leader with expert technical and tactical regulatory... ...Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In...WebsiteSummer workLocal areaRemote workFlexible hours2 days per week$198k - $297k
...platforms across LC1/2, Vertex's Cell & Gene Therapy (CGT) site. It is also the single... ..., quality, and DTE leaders, acting as a strategic partner... ...environments, partnering with DTE Compliance, Cyber Security, Internal... ...expertise.Excellent analytical, problem-solving,...WebsiteFull timeSummer workLocal areaRemote workFlexible hours2 days per week$212k - $333.19k
...Senior Director, Global Program Leader - Oncology, Solid Tumors in... ...VisionStrong Analytical CredibilityExecution SkillsStakeholder... ...or novel modalities such as Cell Therapy or Gene Therapy, large scale programs... ...various meetings or client sites, including overnight trips....WebsiteMinimum wageTemporary workWork at officeLocal areaRemote workNight shift$156.6k - $234.8k
...quality oversight for cell and gene therapy programs across... ...management, ensuring compliance with GxP regulations,... ...medicine requirements.Lead QA review and approval of... ...platforms, data analytics, automation technologies... ...Hybrid-Eligible Or On-Site EligibleFlex Eligibility...WebsiteFull timeContract workSummer workRemote workFlexible hours2 days per week- ...Associate Director of Quality Assurance & Food Safety to lead daily QA operations in a USDA FSIS-regulated RTE environment. You will... ...with Operations, R&D, Sanitation and Regulatory teams to ensure compliance and drive continuous improvement. The role reports to the...Website
$38 - $45 per hour
Job Description: The cell and gene analytical technologies team within Vertex cell and genetic therapies... ...and flexible to travel between sites within 2.0 mile distance. Be a strong... ...interpretation. Assist with lab organization and compliance with lab safety protocols. This...WebsiteContract workWork at officeFlexible hoursShift workDay shiftAfternoon shift- ...as tumor suppressor gene loss and their contribution... ...ability of cancer cells to evade immune cell... ...We are seeking a Site Management Leader (SML) to oversee all... ...management to ensure compliance with contractual obligations... ...skills Strong analytical thinking and decision...Website
$93.9k - $153.3k
...We are seeking a Scientist, RCM Analytical Development to join our Regeneron Cell Medicines (RCM) team. In this role... ...standard business hours Location: On-site laboratory setting Flexibility... ...biology, design, process, and gene delivery mechanisms Thrive today...WebsiteFull timeWorldwideRelocation packageShift work$75 - $110 per hour
...one of our client’s needs a Cell Therapy Analytics Specialist. This is a contract... ...analytical and quality leaders. Key Responsibilities Analytical... ...expectations for cell and gene therapy products. Experience... ...to a wide variety of job sites. All qualified applicants will...WebsiteHourly payContract workFor contractorsLocal area$42 - $50 per hour
Job Description: The cell and gene analytical technologies team within Vertex cell and genetic therapies (VCGT) is seeking an individual for 6-... ...several assays as required and flexible to travel between sites within 2.0 mile distance. Be a strong team player contributing...WebsiteContract workTemporary workWork at officeMonday to FridayFlexible hoursShift workAfternoon shift- ...(MLS TS). Under supervision, you will oversee POC testing, instrument validation, IQCP review, QC/QA, training, and regulatory activities at inpatient and outpatient sites. The role requires CLIA-based testing, a Bachelor's degree in MLS or related field, ASCP certification...Website
- JPMorganChase is seeking a Performance, Analytics and Transformation Vice President within the IIS Operations Team to optimize performance... ..., product technology, and product management across global sites. The role emphasizes delivering expedient, organized implementations...Website
- ...performance-driven network of 100+ sites across the US, Europe, India,... ...Finance Manager is a senior leader at the intersection of... ...Procurement teams to support contract compliance and operational efficiency.... ...legal stakeholders. Strong analytical, negotiation, and...WebsiteContract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
$148k - $222k
## Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)Applylocations: Boston, MAtime type:... ...VCGT Data Integrity (DI) program*** Define DI compliance operational strategies to be deployed at the local site level and monitored for effectiveness, including...WebsiteSummer workLocal areaRemote workFlexible hours2 days per week$180.8k - $271.2k
...medicine and advanced cell therapies across... ...oversight, governance, compliance, and continuous... ...expertise across CGT QA to resolve critical... ...journey. Analytics, Data Integrity & Continuous... ...for cell and gene therapy, biologics,... ...Hybrid-Eligible Or On-Site Eligible Flex Eligibility...WebsiteSummer workRemote workFlexible hours2 days per week- ...Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel and collaboration across cross-functional teams...Website
- ...production line to the latest breakthroughs in cell therapy, this is work that transforms the... ...unit within Bristol Myers Squibb’s Trial Analytics, Insights, and Planning (TAIP)... ...trial science and applied analytics across site feasibility, enrollment modeling, scenario...WebsiteHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
$122.25k - $176.58k
...mission of the Demand & Supply Leader is to integrate Project... ...products delivery to packaging sites and oversee associated Material... ...Microbiology, Immuno-inflammation, Gene Therapy, Rare Diseases,... ...regulations)Knowledge of data analytics and forecastingProject Management...WebsiteFull time$226.1k - $339.1k
...Summary:The Senior Director, Analytical Development is a senior leadership role within the Cell and Gene Therapy Analytical Development... ...automation capabilities. This leader will oversee teams focused on... ...much more.Flex Designation:On-Site DesignatedFlex Eligibility Status...WebsiteFull timeSummer workFlexible hours$137.8k - $206.8k
...ensure they are conducted in compliance with Good Clinical Practice (... ...CROs, vendors, and investigator sites, to support quality outcomes... ...brings direct, hands-on GCP QA experience supporting... ...devices, combination products, or cell and gene therapy clinical trials.Experience...WebsiteFull timeSummer workRemote workFlexible hours2 days per week$153.9k - $230.9k
...quality assurance and compliance. The Associate Director... ...across assigned shifts for cell therapy manufacturing.... ...requirements, site quality systems, and regulatory... ...shift-based QA oversight for aseptic manufacturing... ...tools, and advanced analytics to perform Quality oversight...WebsiteFull timeSummer workFlexible hoursShift work$119k - $141k
Lead Analyst, Site AnalyticsLocation: Cambridge, MA / Hybrid (This role requires working in-office 3 days per week: Tuesday, Wednesday... ...work too, this is the role for you.As the Lead Analyst, Site Analytics, you will own conversion rate optimization and site analytics...WebsiteFull timeWork at office3 days per week- Novartis seeks a Director-level leader to drive portfolio analytics across enterprise and therapeutic areas, shaping methodologies, communicating insights, and influencing senior decision-makers. This role partners with executives to frame value, trade-offs, and investment...
- ...environments that support research, manufacturing, and compliance in a rapidly evolving industry. The Life Science Sector Leader is responsible for driving the strategic... ...operations.Stay ahead of emerging trends in cell and gene therapy, biologics manufacturing, and...
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