- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …effective communications within the GPT, by interacting with other GxP QA functions ( GMP / IMP QA , Audit Compliance, Quality Management System [QMS] QA ... approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry,… more
- Novo Nordisk Inc. (Durham, NC)
- …customer requirements Ensure processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance of the team ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- University of Rochester (Rochester, NY)
- …ensure compliance with project and regulatory standards + Administration of all internal Quality Assurance ( QA ) systems including investigational drug and ... and management programs, Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead QSR Manager, work closely… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** We are currently seeking an industry leader for a Director , Quality Assurance role, who will report to Executive ... Director , Supplier Quality Management and Audits, within the Global ...Extensive background in Biologics Operations (eg Supplier Management, Manufacturing, Quality Control, Quality Assurance ) +… more
- Chobani (MI)
- …contributes to La Colombe success by leading a transformation and executing all Quality Assurance , Sanitation and Food Safety programs at the Muskegon, MI ... to the SVP for Operations in Muskegon, MI. Responsibilities Lead the manufacturing quality assurance , analytical laboratories, and sanitation teams with a staff… more
- Sumitomo Pharma (Columbus, OH)
- **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of ... motivated, and experienced individual for the position of Associate Director of GMP Quality Control,...regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control… more
- ThermoFisher Scientific (Middleton, WI)
- …services. Integrates operational processes, business development, research & development and quality assurance functions for optimal performance within the labs. ... providing strategic direction, leadership, and management to the biopharma GMP business. The Executive Director will own...facilities management, writing SOPs and PDs. + Oversees the quality assurance and quality control… more
- University of Colorado (Aurora, CO)
- Quality Assurance Coordinator (Entry - Senior Level) - 33462 University Staff **Description** **University of Colorado Anschutz Medical Campus** **School of ... Immunology | ClinImmune Cell & Gene Therapy** **Job Title:** ** Quality Assurance Coordinator (Entry - Senior...SOP Reviews. + Review master batch records, coordinate medical director review of product files, and approve cell therapy… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill an Associate Director of Quality Auditing position. This position will be responsible for providing professional expertise, ... leadership, oversight and planning for the Regeneron Quality Auditing function, with primary emphasis on GMP...letters + Collaborating with Procurement, External Manufacturing, Drug Product Quality , QA & Operations and other team… more
- GE HealthCare (IN)
- …GDP, PV, and GLP related functions. This role reports directly to the Senior Director Global Compliance and Quality Systems Pharmaceutical Diagnostics. ... **Job Description Summary** The Global Compliance Quality Assurance R&D / GCP Leader...role: This role is responsible for providing Leadership and QA oversight to the PDx R&D & GCP activities… more
- Golden State Foods (Conyers, GA)
- …literacy a definite plus. Experience: 5 - 8 years in Quality Assurance or related Technical discipline (in a Senior Technician or management capacity) ... Overview JOB SUMMARY: Supervises the day-to-day activities of QA Technicians to ensure operations and compliance with...fill in and perform all the responsibilities of the Quality Assurance Manager in the absence of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …effective communications within the GPT, by interacting with other GxP QA functions ( GMP / IMP QA , Audit Compliance, Quality Management System [QMS] QA ... and strategic way and through collaboration with other GxP Quality representatives, act as QA point person...teams, as appropriate and as needed + Interact with senior Oncology Franchise leadership teams to ensure Quality… more
- Sumitomo Pharma (Morrisville, NC)
- … has multiple direct reports and reports to the Operational Vice President, Quality Assurance . **Job Duties and Responsibilities** + Provide Quality ... **Sr. Director , Cell Quality ** Sumitomo Pharma America...review, and partner meetings. + Develop, review and/or approve GMP documentation, including but not limited to Specifications, Standard… more
- Amicus Therapeutics (Princeton, NJ)
- …and standards. The EQL Associate Director will also provide the Quality Assurance oversight of Amicus's strategic initiatives, the development of biologics, ... Associate Director , External Quality Lead (Small Molecule)...team of quality professional(s), and for all Quality Assurance activities in support of Amicus's… more
- Catalent Pharma Solutions (Bloomington, IN)
- …and spends extensive time in the areas of improvement. + The Technical Services Senior Director will receive assignments in the form of annual (site specific) ... **Job Title: Sr. Director , Technical Services** **Location: Bloomington, IN** **Position Summary:**...information. + Work cross functionally with Process Development, Manufacturing, Quality Assurance , Quality Control, Supply… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry,… more
- ThermoFisher Scientific (St. Louis, MO)
- …enabling processes and systems. + Works multi-functional with process development, manufacturing, quality assurance , quality control, supply chain, and ... will you make an impact?** The Manufacturing Sciences and Technology (MSAT) Director is responsible for leading all facets of Process Validation, Technology Transfer… more
- Taiho Oncology (Pleasanton, CA)
- …except for Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic ... Sr. Director , Regulatory Affairs Strategy Pleasanton, CA, USA Req...to Clinical, Medical and Safety teams. + Together with Quality Assurance , manage regulatory compliance for sponsor… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Quality Engineering is responsible for leading the ... Quality Engineering function. This team provides quality oversight of qualification and validation activities for start-up and ongoing operations of the Devens… more
