- 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
- Bristol Myers Squibb (Devens, MA)
- …facilities, systems, and equipment are operated and maintained to ensure operational and inspection readiness. The Associate Director GMP Maintenance is ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director GMP Maintenance provides leadership and direction to the 24/7… more
- Novo Nordisk (Clayton, NC)
- …ensuring high quality raw materials for Novo Nordisk US. Relationships Reports to 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
- Bristol Myers Squibb (Summit, NJ)
- …and BMS corporate requirements. + Provides training programs for auditing and various GMP compliance topics. + Manages responses and leads efforts for all ... This individual will be responsible for leading the continuous inspection readiness efforts and the site's self- inspection ...or cell therapy commercial manufacturing facility. + Expertise in GMP compliance , Quality System and global … more
- Lilly (Durham, NC)
- …QA Floor Support team and reports to the QA Parenteral Associate Director . Responsibilities include performing AQL inspections , final classification of defects, ... sample management as well as providing QA oversight to GMP operations in the Parenteral visual inspection areas which includes automated visual inspection ,… more
- ThermoFisher Scientific (Waltham, MA)
- …ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections . + Must be an expert Quality compliance auditor. + Experience ... **Job Description** We are looking for a highly skilled pharma- GMP auditor and risk management leader. This leader will...**What will you do?** We identify systemic gaps in quality/ compliance by conducting internal audits of Thermo Fisher Pharma… more
- Amicus Therapeutics (Princeton, NJ)
- …temperature excursions, product complaints in compliance with the requirements of GMP . * Ensures Inspection Readiness and supports Amicus and our External ... Associate Director , External Quality Lead (Small Molecule) Location Princeton,...actively engaged in ensuring outsourced manufacturing is performed in compliance with Amicus procedures and standards, and applicable regulations… more
- Olympus Corporation of the Americas (San Jose, CA)
- …Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and ... inspections and audits and ensures successful outcomes through inspection readiness activities, inspection management and observations resolution. +… more
- University of Rochester (Rochester, NY)
- …GCPs, GLPs, and other regulatory agencies (eg OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211. + Responsible to ... of international regulatory standards as necessary to maintain internal and regulatory compliance . Participate in external and internal inspections from client… more
- Rhythm Pharmaceuticals (Boston, MA)
- …validated electronic system that houses all of Rhythm's GxP records. The Associate Director QA will lead the Quality and Compliance governance and ensures ... for continuous improvement and maintain a steadfast growth in Rhythm's quality culture and compliance stance. The Associate Director QA will report to the Head… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … inspection management activities by ensuring readiness, compliance , and inspection preparedness for the respective PV inspections in alignment with ... areas centered around rare diseases and immune disorders. **Summary** The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA,… more
- Astellas Pharma (Westborough, MA)
- ** Director , Manufacturing Operations** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... AIRM is headquartered in Massachusetts. Astellas is announcing a ** Director , Manufacturing Operations** opportunity at their **Astellas Institute for Regenerative… more
- Sanofi Group (Morristown, NJ)
- …environment. Consumer Healthcare or Pharma industry preferred + Strong knowledge in GMP Regulatory Compliance , including Regulatory audits + Certified Quality ... **Associate Director , Quality - US Consumer Healthcare (CHC)** +...quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable… more
- Lilly (Lebanon, IN)
- …enhances organizational capabilities and ensures personnel qualification. The Associate Director is responsible for enhancing employees' capabilities to meet site ... training meet corporate and site quality standards. Additionally, the Associate Director will oversee performance consulting for business partners to assess critical… more
- Lilly (Lebanon, IN)
- …GMP manufacturing operations._ **Position Brand Description:** The Associate Director Manufacturing Operations is directly responsible for managing the day-to-day ... and continuous improvement in pursuit of Operational Excellence. The Associate Director Manufacturing Operations provides leadership, acts as a key integrator, has… more
- J&J Family of Companies (Raritan, NJ)
- …Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves as SME for QA ... Director , Quality Assurance Operations - 2406190855W **Description** Janssen...of the Raritan CAR T manufacturing site, in full compliance with established cGMP, J&J and JSC requirements. Functions… more
- ThermoFisher Scientific (St. Louis, MO)
- …St. Louis site as a domain expert during external and internal regulatory compliance inspections . + Support the authoring, reviewing and approving of regulatory ... will you make an impact?** The Manufacturing Sciences and Technology (MSAT) Director is responsible for leading all facets of Process Validation, Technology Transfer… more
- Bristol Myers Squibb (Seattle, WA)
- …years of experience in a PQL role is preferred + Expertise in GMP compliance , global regulations and strong understanding of pharmaceutical product development ... Analytical Development, Site Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Senior Director , Purification Process Development - Pivotal & Commercial Biologics** The Senior ... Director of Purification Process Development for Pivotal and Commercial...transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on… more
- Transylvania Vocational Services (Brevard, NC)
- …and internal audits, sanitation, quality systems reviews, incoming ingredient inspection , food safety audits, consumer complaints, and standardized work ... and employees related to quality, sanitation, and food safety functions. + Ensure compliance with USDA, FDA, and other regulatory bodies; act as a liaison between… more