Global R&D QA & Compliance Director
Tris Pharma
Tris Pharma, Inc. in New Jersey seeks an experienced R&D Quality Assurance leader to oversee a small QA/R&D unit. The role provides strategic guidance on GxP compliance for clinical and nonclinical programs, pharmacovigilance and medical affairs, with partnerships across R&D and Regulatory groups. The incumbent leads QA governance, inspection readiness and data integrity initiatives to ensure patient safety and regulatory compliance throughout development lifecycles. #J-18808-Ljbffr Tris Pharma
- Tris Pharma, Inc. is seeking an experienced Senior/Executive Director of R&D Quality Assurance to lead global QA/Compliance programs across R&D, Clinical, and Pharmacovigilance. The role demands strategic leadership, regulatory liaison with FDA/EMA, and building a robust...Suggested
- ...is seeking an experienced Senior or Executive Director of Research and Development Quality Assurance to lead our R&D QA programs in a hybrid NJ setting. This senior role... ...safety, and regulatory readiness across global development stages. You will drive risk-based quality...Suggested
$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...SuggestedPermanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
...Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support... ...relied on to articulate clear and compelling global regulatory strategies, highlighting... ...reviews current policies and practices in compliance with Federal and international regulatory...SuggestedPermanent employmentFull timeWork at officeWork from home$111k - $135.5k
...manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e.... ...of sterile and OSD manufacturing/packaging records from a Global Quality perspective.QA SME for manufacturing (Sterile & OSD), environmental monitoring...SuggestedFlexible hours$164k - $282.9k
...way. Learn more at We are searching for the best talent for the Director, Global Medical Affairs Strategy & Execution (Oncology) to be based in... ...interactions with GMAL, Medical Affairs directors, Janssen R&D clinical scientists, global and regional marketing directors,...Full timeLocal areaImmediate startWorldwide$160.88k - $241.32k
...serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued... ...on Genmabs 2030 vision, we are looking for an Associate Director for the R&D Strategic Initiatives. The R&D Strategic Initiatives (RDSI)...Full timeFixed term contractWork experience placement- ...opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.The Global Trade & Compliance Optimization Manager is an individual contributor responsible for driving compliant duty optimization and classification...Full time
$150k - $258.75k
...Description Johnson & Johnson Innovative Medicine's Global Commercial Strategy Organization is recruiting for a Director, Global Portfolio Strategy & New Business... ...Plan and selected GOC accelerators. Partner with R&D, Finance, Therapeutic Areas, Regions, and other enterprise...Local areaImmediate start- ...00The compensation range provided is in compliance with state specific laws. Factors that may... ...visit We Are:Guest Worldwide is a global collective of dynamic, industry-leading... ...world. Learn more by visiting The Senior Director of Global Procurement & Strategic Sourcing...Full timeLocal areaWorldwide
$137k - $235.75k
...IM) is recruiting for an Associate Director of AI Quality and Governance - R&D Data Science & Digital Health.This... ...with DSDH teams, Quality, Legal, Global Regulatory Affairs, and Johnson &... ...ethics, governance, or regulatory compliance.6 - 8+ years of experience working...Full timeLocal areaImmediate start- ...a Senior Manager, Regulatory Affairs Labeling Product Leader for a hybrid role based in New Jersey or Pennsylvania. You will drive global labeling strategy, lead target labeling development, and collaborate with cross-functional teams to align labeling with product strategy...
- Medasource is seeking a Regulatory Program Manager to lead global regulatory strategies and execution for oncology programs. The role requires coordinating cross-functional teams, managing submissions, and accelerating timelines. Expect a high-visibility, hybrid work arrangement...
- Johnson & Johnson is seeking a Director, R&D Business Operations, capable of leading multiple optimization projects across global R&D. The role emphasizes strategic thinking, stakeholder management, and strong project leadership in Innovative Medicine R&D. Located in Raritan...
$178k - $307.05k
...Synthes is recruiting for a Sr. Director, Regulatory Law, located in... ...legal leader supporting the global regulatory activities of DePuy... ...Regulatory Affairs, Quality, R&D, and Commercial teams, and... ...strategy to enable innovation, compliance, and sustainable growth. This...Full timeImmediate start- ...seeks an experienced Regulatory Affairs professional to support global medical diagnostic products. The role involves registering and... ...questions, improving processes with RPA, and ensuring regulatory compliance across US and international markets. You will participate in...
$77.52k - $101.75k
...loc. JOB SUMMARY: Support and assist the QA function to ensure manufacturing quality controls... ...multiple depts, including Lab Ops (MV/QC/R&D-QA), Product Dev, Tech Svcs, Eng,... ...and IT. Maintain quality documentation in compliance with company policies, SOPs, cGMPs, and records...$150k - $170k
...partners closely with cross-functional teams and global regulatory stakeholders to ensure timely submissions, regulatory compliance, and alignment with product development... ...collaboration across cross-functional teams, including R&D, clinical, quality, operations, legal, and...For contractorsWork at officeRemote workHome officeNight shift$189.7k - $237.1k
...Position Summary Director, Regulatory CMC. Role can be based in San... ...and ex-US). Coordinate with R&D, Pharmaceutical Development,... ...regulatory risks. Ensure CMC compliance with applicable regulatory requirements... ...role. Knowledge of global regulatory CMC requirements/guidelines...Work at officeWorldwide3 days per week$102k - $177.1k
...AuditingIndependently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of... ...adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits...Full timeWork experience placementLocal areaImmediate start- ...live better. This is Our Purpose.We are a global leader in medical imaging, offering an... ...FORGuerbet is looking for a qualified, dynamic QA Manager to enhance our quality management... ..., review, and revision, ensuring compliance with FDA regulations including CFR (Code...For contractorsLocal area
- ...products. We have an exciting opportunity for an Associate Director of Testing & Regulatory Compliance based at our Corporate Headquarters in Metuchen, NJ to... ...). This role serves as the subject matter expert for global product safety regulations, testing protocols,...
$137k - $235.75k
...submission.Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager,... ...responsible for the following:Drive the global labeling strategy, including... ...:Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry...Full timeWork experience placementLocal areaImmediate startWorldwide$127.31k - $167.1k
...Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered... ...development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards....Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$168.37k - $220.99k
...Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing... .... Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory... ...a lawful workforce and ensuring compliance with federal employment regulations, we...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...strengthening our U.S. -based quality management system and integrating global operations as we transition from development to... ...Management System (QMS): Lead remediation of U.S. QMS. Ensure compliance with FDA QSR and ISO 13485. Harmonize U.S. and China quality...Overseas
$189.7k - $237.1k
...Position Summary Join Acadia as the Director, Regulatory CMC and play a... ...you will develop and execute global regulatory CMC strategies... ...requirements Coordinates with R&D, Pharmaceutical Development,... ...Participates in ensuring compliance of CMC activities with applicable...Work at officeLocal areaRemote workWorldwideNight shift3 days per week$178k - $307.05k
Sr. Director, Regulatory Law Locations: New Brunswick, New Jersey;... ...Regulatory Law. You will support global regulatory activities in... ...Regulatory Affairs, Quality, R&D, and Commercial teams, and shape... ...to enable innovation, compliance, and sustainable growth. Key...Immediate start- ...Bristol-Myers Squibb is looking for a Director, Global Medical Affairs for Sjogren’s Disease in Princeton, NJ. This role involves leading the medical strategy and execution for Sjogren’s Disease across global markets, ensuring alignment of medical affairs with commercial...
- ...Johnson & Johnson seeks a Director, Global Medical Affairs Strategy & Execution in Raritan, NJ. You will partner with GMAL to own strategy, generate integrated evidence plans, and lead publications across designated therapeutic areas. This role requires significant...
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