- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection...we are performing with in compliance . The Director will also provide support during regulatory inspections… more
- Lilly (Indianapolis, IN)
- …quality oversight of Indianapolis Parenteral Manufacturing's central quality processes. The Associate Director for Site Quality & Compliance is responsible for ... for complaint investigation management and oversight of the IPM GMP Library within the Site Quality & Compliance...quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readiness + Actively participate… more
- Novo Nordisk (Clayton, NC)
- …interest in ensuring high quality raw materials for Novo Nordisk US. Relationships Director , US Sourcing Hub. Essential Functions + Responsible for raw materials & ... based on the use at Novo Nordisk to ensure compliance & patient safety + Participation in approval of...organizations + Prepare proper documentation of activities to ensure inspection readiness + Other accountabilities, as may be assigned… more
- Actalent (Cincinnati, OH)
- …and controls are in conformance with the regulations. + Assessing Vendors for Compliance and monitoring studies performed at the vendors + Providing audit reports ... responsible. + Periodically submit to management and the study director written status reports on each study, noting any...the final study report which shall specify the dates inspections were made and findings reported to management and… more
- Takeda Pharmaceuticals (Boston, MA)
- …operational and compliance metrics and storyboards, identify quality and compliance inspection risks, and provide tactical directions in the mitigation. ... to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, MA **About the role:**… more
- Amicus Therapeutics (Marlow, OK)
- …and Quality Control activities within Amicus and External Partners. . Facilitate or host GMP inspections by regulatory authorities and maintain a state of ... for leading Amicus' Quality Operations Team, ensuring a robust GMP Quality System and compliance of our...PMDA, and other global regulatory agencies. Ensure readiness for inspections of both internal and external GMP … more
- Lilly (Pleasant Prairie, WI)
- …place and maintained. He/she leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, ... to increase the value of Lilly products. The Senior Director , Quality Assurance, is primarily responsible for overseeing the...and lead the Quality Lead Team. + Ensure overall compliance with GMP regulations, Lilly Corporate Quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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 Quality Systems & Compliance department. The role is highly visible, offer tremendous growth potential, and requires… more
- Merck (West Point, PA)
- …The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, ... **Job Description** **Position Description:** **Associate Director , Quality Systems & Compliance ** Our...forums. + Prior experience at a health authority performing GMP inspections . + Demonstrated ability to establish… more
- Charles River Laboratories (CA)
- …that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance ** to join our **Insourcing ... San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance ** ,...up, of internal and external site visits, audits, and inspections eg, client audits, the IACUC, outside regulatory and… more