Head of Quality Assurance, Drug Product, GMP QA
Daiichi Sankyo, Inc.
Job Requisition ID: 1674 Posting Start Date: 6/22/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable
$226.28k - $377.13k
...families, and society.Job SummaryThe Head of Quality Assurance, Drug Product is accountable for the quality oversight... ...for leading an independent QA function, with authority for final batch... ...from production per Daiichi Sankyo’s GMP Quality Manuals Resolve issues in internal...SuggestedContract workLocal area- Daiichi Sankyo US is seeking a Head of Quality Assurance for Drug Product in Basking Ridge, New Jersey. This role involves ensuring quality oversight of internal sites and CDMOs, and leading an independent QA function to maintain compliance with industry regulations. The...Suggested
- System One is seeking a QA Product Manager to oversee quality assurance for sterile products. Based in Florham Park, New Jersey, this role involves reviewing batch records, managing CAPAs, and coordinating investigations. Candidates should have a minimum of 4 years of QA...Suggested
$120k - $150k
Overview The QA Product Manager (Sterile Products) plays... ...critical role in ensuring the quality, safety, and regulatory... ..., support sterility assurance and contamination... ...transfer projects for drug substance and/or drug product... ...of global GMP and regulatory requirements...SuggestedFull timeWork at officeLocal area- Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring... ...operations. The role involves oversight of Quality Management Systems, partnering with... ..., and supporting validation efforts for drug products. Ideal candidates will have over 7 years...SuggestedContract work
$149.16k - $223.74k
...StructureReports To: Sr Director Quality CMO - RDDirect Reports: 2 reports in EuropeAreas Managed: QA operations oversighting... ...Organization (ESO)OverviewThe QA Director GMP ESO Biotechnologies is... ...industrial technology transfer of the product (MSAT Projects) as applicable,...Temporary workWork at officeLocal areaNight shiftWeekend work3 days per week$45 - $59 per hour
...Job Title: QA Product Manager (Sterile Products) Location: Florham... ...contract manufacturers to resolve quality issues, monitor compliance,... ...of QA experience in sterile drug product manufacturing/... ...CAPA management, and sterility assurance. Direct experience with third...Hourly payOngoing contractContract workTemporary workFor contractorsZero hours contractLocal areaRemote work- Merck & Co. seeks a Quality Assurance professional to oversee contract manufacturing organizations, ensuring compliance with FDA regulations... ...extensive pharmaceutical experience and knowledge in drug manufacturing and QA compliance. This position is poised for impact in a...Contract work
$61.45k - $80.66k
...Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan... ...that occur in the production of a personalized... ...product in a sterile GMP environment. The... ...preferably in quality assurance, manufacturing... ...Biotech maintains a drug-free workplace. Voluntary...Temporary workFor contractorsWork experience placementFlexible hours$120k - $150k
Shionogi Inc. (U.S.) in Florham Park, NJ, is seeking a QA Product Manager to ensure quality and compliance of sterile pharmaceutical products. The... ...will have at least five years of pharmaceutical Quality Assurance experience, lead technology transfer projects, and manage...$153.6k - $230.4k
Daiichi Sankyo US is seeking a Quality Assurance Lead to oversee Contract Manufacturing compliance in Basking Ridge, New Jersey. The successful candidate will be responsible for ensuring that all contracted organizations comply with FDA regulations and internal quality...Contract work$120k - $150k
Shionogi Inc. is seeking a QA Product Manager for Sterile Products in Florham Park, NJ. This critical role ensures the quality, safety, and compliance of sterile pharmaceutical products... ...five years in pharmaceutical Quality Assurance, and experience with sterile products....$176.4k - $327.6k
...Purpose:Lead/manage and/or provide quality oversight in development and... ...systems and procedures, product release and handover, or projects... ...which may include GCP, PV, GLP, GMP (including medical device), IP... ....Proactively provide strong QA leadership to the business by...Full timeLocal areaRelocation package$158.14k - $194.47k
...enemy: disease. As Director, Quality Control you will be... ...testing at contract labs for drug substance, drug product, and stability programs across... ...Development, Technical Operations, QA, and CMC Regulatory Affairs... ...audits, and management of GMP-related exceptions (e.g., deviations...Full timeContract workTemporary workLocal areaFlexible hours$153.6k - $230.4k
...the implementation of the quality strategy closely aligned... ...strategic and proactive QA Leadership and support... ...close alignment with the Head of Global PV QA Americas... ...Reviews of respective product profile to ensure appropriate... ...functions (R&D Quality, GMP/ IMP QA, Audit, Quality...Local areaWorldwide- Daiichi Sankyo, Inc. seeks a Director, PV QA DSI to lead the planning and implementation of the Quality Assurance strategy within CSPV in the US. This role provides operational... ...involvement and ensures quality oversight of products with REMS, collaborating with Global Audits,...
- ...QA Lead Location: Berkeley Heights, NJ (Onsite) Type: Contract (Automation, Selenium... ...Utilities. Develop and write high quality coding that meets customer requirements... ...planning and executing the end to end QA and product testing Coordinate in fixing the reported...Contract work
$139.55k
..., while providing flexibility to support productivity and work‑life balance. This approach combines... ...and Billing Claims Adjudication Quality Center JIRA Salary range: $139,545.12 – $... ...Management Exempt. Job Family: IFT IT Test/QA & Release Mgmt. Elevance Health is an Equal...Work at officeLocal areaMonday to Friday3 days per week- Job Title: QA Director Job ID: 2024-13197 Job Location: Omaha, NE, Berkeley Heights,... ...reports and 36 indirect reports. Drive Quality Practices and Standards across the Organization... ...all quality metrics at team, process and production operating levels Make data-driven...Permanent employmentLocal areaRelocation
$95k - $145k
...verbal communication skillsMeticulous attention to detail and quality of work productAbility to build and sustain professional relationshipsAbility to... ...and supporting inspection readiness for Food and Drug Administration or European Medicines Agency auditsExperience...Remote workVisa sponsorship- Legend Biotech seeks a QA Investigations Lead I to oversee quality investigations in Raritan, NJ. This role involves... ...robust investigations in a GMP environment, supporting regulatory... ...experience, preferably in quality assurance or clinical quality within aseptic...
$61.45k - $80.66k
A leading biotechnology company in Raritan, NJ seeks a QA Investigations Lead I. Responsibilities include overseeing quality investigations and ensuring compliance within a GMP environment. Ideal candidates should possess a Bachelor’s Degree and 2-4 years of relevant experience...$90k - $210k
...Manager Of Quality Control We are seeking an innovative and highly... ...of Quality Control at our GMP manufacturing facility located... ...manufacturing of cellular therapy products. This individual will lead... ...mass manufacturing the living drugs of the 21st century. The company...Contract workFor contractorsFlexible hours$124k
...Role: We're looking for a Manager, Quality Control (QC) on the Quality Control team... ...for inhalation and small molecule drug substance, drug products, including raw materials, in-process,... ...Analytical Development, Regulatory Affairs, QA, and Supply Chain to support product...Full timeContract workWork at officeLocal areaFlexible hours$173k - $216k
...immunology or delivering high-quality medicine worldwide, we’... ...US Quality Systems of product distribution,... ...regulatory event reporting, drug shortage reporting,... ...System in compliance with GMP&GDP and Teva Corporate... ...Pharmaceutical Quality Assurance, US FDA and Regulatory...Local areaWorldwideFlexible hours$184.24k - $276.36k
Initial Therapeutics, Inc. is seeking a Director, PV QA DSI to lead the Quality Assurance strategy within Clinical Safety and Pharmacovigilance (CSPV). This role will oversee PV QA activities, ensuring compliance with regulatory requirements while leading a high-performing...- ...criteria. Coordinate with business users, BAs, development, and QA teams. Manage test execution, defect tracking, triage,... ...functional requirements. Coordinate business sign-off and production readiness. Strong communication and stakeholder-management...
- Daiichi Sankyo US is looking for a Director, PV QA DSI to lead quality assurance strategies within Clinical Safety and Pharmacovigilance. The role involves ensuring compliance with regulatory requirements and actively engaging with internal and external stakeholders to...
- ...one of the largest and most productive asphalt plants in the United... ...We are seeking an experienced Quality Control Manager with proven leadership... ...to verify adherence to QA/QC Management Plan. Develop... ...to attain the NETTCP Quality Assurance Technologist and USACE...Full timeContract workTemporary workPart timeFor subcontractor
$120k - $145k
...Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s... ...the Vice President, Quality Assurance and will manage or support:... ...SOP and Training systems, QA/QC Testing /Audit program,...Contract workFlexible hours
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