- AbbVie (Waltham, MA)
- …agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by ... Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of… more
- Charles River Laboratories (Wayne, PA)
- …regulatory auditors prepare appropriate summaries and reports of such audits. ⦁ Review and endorse regulatory and client audit responses and corrective action ... applications, supplements, annual reports, and master files. ⦁ Participate in the review and development of quality agreements with clients and contract service… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …role is responsible for ensuring that medical affairs activities comply with pharmaceutical regulations and laws and providing expertise on drug safety and medical ... multiple myeloma on various activities: Field team resources, Medical Review Committee, External grant review / evaluation,...degree (ie, MD, PharmD, PhD) and 2+ years of biotech/ pharmaceutical industry experience OR + Master's Degree and 6+… more
- Chiesi (Cary, NC)
- …care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social ... many other enriching diversities. Chiesi USA Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent… more
- BeOne Medicines (San Mateo, CA)
- …pharmaceutical product(s), including participation in promotional and medical review processes, preferably in oncology and for accelerated approval product(s). ... **General Description:** We are seeking an experienced biotechnology/ pharmaceutical law attorney to provide legal support, counseling, and strategic guidance on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification ... write/draft discrepancy report; assist in performing non-conformance investigations for pharmaceutical manufacturing; Create/modify change control requests, project plans and… more
- Kelly Services (Sacramento, CA)
- …Manager** for **a Direct Hire opportunity** at an innovative and growing pharmaceutical manufacturing client in Sacramento, CA. If you're passionate about bringing ... issues as needed on call for nights and weekends. **Overview** Our client is a pharmaceutical company looking to grow their Quality Team and is looking to add people… more
- Cambrex High Point (Longmont, CO)
- …non-GMP and GMP batch records from process description using template, as needed. Review batch records written by other Manufacturing Chemists and review ... and EHS to address safety risks identified during process review . Helps drive safety culture in Manufacturing group. +...Experience + HS diploma with 17+ years of relevant pharmaceutical drug substance API manufacturing experience, OR + BS… more
- Sumitomo Pharma (Nashville, TN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse… more
- Catalent Pharma Solutions (San Diego, CA)
- …annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical ... activities, in addition to developing and managing business relationships for major pharmaceutical clients. The primary function of the Project Manager is to… more