Global QA Lead, Drug Product & Compliance
Daiichi Sankyo US
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 ideal candidate will have over 10 years of experience in Quality Assurance within a global pharmaceutical organization, strong leadership capabilities, and a Bachelor’s Degree in a science-related field. A commitment to continuous improvement and risk management is essential. #J-18808-Ljbffr Daiichi Sankyo US
$226.28k - $377.13k
...vision to "be an innovative global healthcare company... ...of Quality Assurance, Drug Product is accountable for the... ...Organizations (CDMO).The role leads the site's independent... ...to assure supply and compliance while promoting a... ...leading an independent QA function, with authority...SuggestedContract workLocal area- ...manufacturing organizations, ensuring compliance with FDA regulations and internal... ...pharmaceutical experience and knowledge in drug manufacturing and QA compliance. This position is poised... ...environment, supporting global operations with potential travel requirements...SuggestedContract work
$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 ideal... ...years of pharmaceutical Quality Assurance experience, lead technology transfer projects, and manage compliance audits...Suggested$120k - $150k
Overview The QA Product Manager (Sterile Products) plays... ...safety, and regulatory compliance of sterile pharmaceutical... ...-functionally with global internal teams and external... .... Responsibilities Lead and coordinate end-to-end... ...transfer projects for drug substance and/or drug product...SuggestedFull timeWork at officeLocal area- Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves... ...quality leaders, and supporting validation efforts for drug products. Ideal candidates will have over 7 years in the...SuggestedContract work
- 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...
$120k - $150k
Shionogi Inc. is seeking a QA Product Manager for Sterile Products in Florham Park, NJ. This... ...role ensures the quality, safety, and compliance of sterile pharmaceutical products with... ...including overseeing validation activities, leading technology transfer projects, and...$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...$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- Daiichi Sankyo, Inc. seeks a Director, PV QA DSI to lead the planning and implementation of the Quality Assurance... ...involvement and ensures quality oversight of products with REMS, collaborating with Global Audits, Compliance, Development and Medical QA. The incumbent will...
$45 - $59 per hour
...Job Title: QA Product Manager (Sterile Products) Location:... ...resolve quality issues, monitor compliance, and ensure product release... ...quality and supply continuity. Lead large-scale technology... ...of QA experience in sterile drug product manufacturing/oversight...Hourly payOngoing contractContract workFor contractorsZero hours contractLocal areaRemote work$153.6k - $230.4k
...vision to "be an innovative global healthcare company... ...strategic and proactive QA Leadership and support... ...with adequate quality and compliance guidance in close... ...PV inspections/Audits. Lead in a proactive and strategic... ...Reviews of respective product profile to ensure...Local areaWorldwide$61.45k - $80.66k
...Legend Biotech is seeking QA Investigations Lead I as part of the Quality team... ...events that occur in the production of a personalized cell therapy... ...audits as needed. Support compliance activities for site Quality... ...Legend Biotech maintains a drug-free workplace. Voluntary...Temporary workFor contractorsWork experience placementFlexible hours- Legend Biotech seeks a QA Investigations Lead I to oversee quality investigations in Raritan, NJ. This role involves ensuring robust investigations in a GMP environment, supporting regulatory compliance, and collaborating with various teams. The ideal candidate holds a...
$127.28k - $190.92k
...by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable... ..., Global Vendor Quality (Global R&D & PV QA) supports the development, implementation... ...vendor qualification, oversight, and compliance activities are performed in accordance...$99k - $232k
...Execution Leader within our Software and Product Innovation practice, you will play a pivotal... ...client expectations. You are expected to lead with integrity and authenticity,... ...insights for system improvements- Confirming compliance with quality assurance best practices and...Full timeH1b$95k - $145k
...Drive validation and compliance activities for complex... ...will be responsible for… Lead end-to-end validation... ...and quality of work productAbility to build and sustain professional... ...for Food and Drug Administration or... ...your inquiries to the Global Call Center (GCC) at USTalentCICInbox...Remote workVisa sponsorship- ...We are seeking an experienced QA Lead to join our team in supporting the development of a centralized data management hub that powers... ...keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Required Skills &...
- ...Position: QA Lead Location: Morristown, NJ/Austin, TX/Memphis, TN (Hybrid-2 Days Onsite) Duration: 12 Months (Contract... ...of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and...Contract workFlexible hours
- ...QA Lead Location: Berkeley Heights, NJ (Onsite) Type: Contract (Automation, Selenium, Mobile, Web Testing) Analyze Business Requirements... ...test teams in planning and executing the end to end QA and product testing Coordinate in fixing the reported issues found in...Contract work
$100k - $130k
...control and collaborative workflows ~ QA fundamentals test design techniques, methodologies... ..., reporting, and reusable utilities. Lead test planning, test case design, and... .... Collaborate closely with product, design, and engineering to embed quality...Shift work$99k - $232k
...Transformation - Testing Strategy & Planning Lead - Manager, you will drive the development... ..., you will be part of our Software and Product Innovation group, focusing on testing and... ...documentation testing to confirm compliance with specified requirements- Facilitating...Full timeH1b$176.4k - $327.6k
...for you. Role Purpose:Lead/manage and/or provide quality... ...and procedures, product release and handover, or... ...projects in order to ensure compliance with health authorities... ...provide strong QA leadership to the business... ...activitiesLead and manage a global QA organization and/or...Full timeLocal areaRelocation package- 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...
$102k - $177.1k
...currently recruiting for a Manager, Clinical QA Program Lead-Two Openings! This position can be... ...stakeholders to resolve and address compliance related matters and identify opportunities... ...of audit processes ensuring global alignment and harmonisation across domains...Full timeLocal areaImmediate start3 days per week$158.14k - $194.47k
...at contract labs for drug substance, drug product, and stability programs... ...Operations, QA, and CMC Regulatory Affairs... ...validations, ensuring compliance with regulatory standards... ...objectives.Build and lead high-performing team.... ...managing FDA and global regulatory inspections...Full timeContract workTemporary workLocal areaFlexible hours- The Cigna Group in Morris Plains, NJ invites a QA Testing Lead Analyst to lead testing across QA and production environments in a hybrid role. You will design test plans, write test scripts, and drive automation using Playwright and other tools within an Agile CI/CD framework...
$90k - $210k
...manufacturing of cellular therapy products. This individual will lead a group of QC analysts... ...accuracy and regulatory compliance Create/Review and... ...manufacturing the living drugs of the 21st century. The... ...demand for cell therapies at global scale. Partnering with...Contract workFor contractorsFlexible hours$124k
...person who joins in. As a global biopharmaceutical... ...you'll independently lead and oversee all QC... ...inhalation and small molecule drug substance, drug products, including raw... ...Regulatory Affairs, QA, and Supply Chain to... ...completeness, accuracy, and compliance with internal and...Full timeContract workWork at officeLocal areaFlexible hours$173k - $216k
...Are TevaWe’re Teva, a leading innovative biopharmaceutical... ...US Quality Systems of product distribution,... ...associated resources, compliance activities including complaints... ...regulatory event reporting, drug shortage reporting,... ...Meetings with Global Quality units and Quality...Local areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global QA Lead, Drug Product & Compliance. Be the first to apply!
- director quality assurance regulatory affairs Basking Ridge, NJ
- quality assurance Basking Ridge, NJ
- qa Basking Ridge, NJ
- director quality assurance Basking Ridge, NJ
- quality assurance representative Basking Ridge, NJ
- quality assurance team leader Basking Ridge, NJ
- work from home qa testing Basking Ridge, NJ
- lead qa Basking Ridge, NJ
- compliance lead Basking Ridge, NJ
- medical compliance Basking Ridge, NJ

