- 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 (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
- Lilly (Durham, NC)
- …external regulatory inspections . + Review and / or redline to GMP documents ensure quality attributes are met. (ie, deviations / observations, procedures, ... and Quality System from the ground up. The Sr Manager for QA Visual Inspections Operations is responsible for providing leadership and daily support and oversight to… 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
- 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
- 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
- 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
- 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
- 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
- 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, PV/MA ... to patient's rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic way and through… 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
- Merck (West Point, PA)
- …of regulatory trends, and implement action plans to proactively address potential GMP compliance impact **Minimum Education Required and Experience:** + ... **Job Description** The Director , QMS Topic Owner role is critical in...Management System (QMS) Chapter 3 - Quality Systems & Compliance , as well as local SOP's and related documents… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive...ASMFs, etc. and ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may… 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
- 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
- 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
- Hovione (Tina, MO)
- …contribute to and support the Corporate HSE Leadership team mandate. - Ensure compliance with GMP and HSE guidelines, internal and external requirements as ... training and communication and monitoring implementation through audit and inspection . Conducts and supports incident investigations and risk assessments. Develops… more