- 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
- 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
- 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
- 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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …agencies. + Function as the CMC QA subject matter expert during regulation inspections . + Participate in the site inspection readiness program. + Support ... real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC, you will be responsible for providing operational… more
- Organon & Co. (Plymouth Meeting, PA)
- …technical advice, counseling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for External Quality Assurance ... Behaviors and provides a leadership example for the team. + Assures compliance with established policies/procedures of the Division and Corporation and complies with… more
- Gilead Sciences, Inc. (Frederick, MD)
- …+ Support and participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections . + Follow ... highly motivated individual to join us as an Associate Director , to lead Quality Control Analytical Tech Services group,...Well versed and experienced in bioanalytical methods working under GMP conditions. + Deep experience in applying GMP… 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
- BeiGene (San Mateo, CA)
- …controlled way that is in accordance with regulatory expectations and applicable GMP /GDP quality standards. The role has global responsibility and accountability for ... CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed. +...commercial supply eg timely batch release + Support GCP inspections in IMP manufacturing perspective + Execute product recalls… 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
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …on the IOPS CMC intelligence program + Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities ... The Director of CMC Industry and Regulatory Intelligence is...for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead **Location** : ... Cruiserath / Devens The Associate Director of Analytical Strategy & Lifecycle will lead a.../ Method Validation/ analytical comparability/reference standard strategy) and associated GMP 's. + Proven track record in independently authoring complex… more