- 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
- Curia (Albuquerque, NM)
- Director of Quality Systems and Compliance in Albuquerque, NM. Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Director of Quality Systems and Compliance is...GMP areas and responsibilities are maintained in permanent inspection -ready state. + Ensure registrations and agency submissions are… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Quality System Compliance Date: Apr 10, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 55102 **Who ... a difference, and new people to make a difference with. **The opportunity** The Director of Global Quality Systems Compliance plays a critical role in overseeing… more
- ThermoFisher Scientific (St. Louis, MO)
- **Job Description** **1.** **Pur** **p** **ose of the** **Job** The Director Site Compliance is responsible for the site senior leadership oversight of key ... leadership meetings and site strategic meetings. The Directo Site Compliance , role will report to the Sr. Director...operational or quality organizations + Strong experience working on GMP clinical and commercial operations as well a … more
- Sumitomo Pharma (Morrisville, NC)
- …a prepared state of inspection readiness through training, leadership and inspection management during Agency inspections . + Lead the Quality representation ... **Sr. Director , Cell Quality** Sumitomo Pharma America (SMPA) is...This role fosters a quality culture and mindset for inspection readiness and continuous improvement, while supporting manufacturing facility… 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
- Bristol Myers Squibb (Bothell, WA)
- …AD of QA Operations Shop Floor will be to provide quality oversight of GMP operations and ensure compliance with all relevant quality standards and regulations ... Bothell Manufacturing site. + Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections . + Assists in the design,… 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
- Compass Group, North America (Chesterfield, MO)
- ESFM Position Title: [[Assistant Director , Operations III]] Reports To: Salary: [[Experienced]] Pay Grade: [[13]] Other Forms of Compensation: [[none]] ESFM is the ... refer a friend to this position. Job Summary The GMP Manager manages a staff for the cleaning of...Environment Cleaning program. + Perform audits to monitor cleaning compliance . + Collaborate with clients to develop cleaning solutions… 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
- Catalent Pharma Solutions (Harmans, MD)
- **Position Summary** The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... CAPA tracking, change control, risk management, supplier quality, audits and inspections , raw materials release, and compiling, trending and reporting key quality… more
- Catalent Pharma Solutions (Bloomington, IN)
- **Position Summary** The Director of Quality Systems is responsible for managing pharmaceutical quality systems governance. Reporting to the VP of Quality, the ... Director of Quality Systems will manage all quality systems,...documentation, as well as other process improvement initiatives, in compliance with GxP regulations + Possess a strong background… 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)
- …into GMP manufacturing operations._ **Position Brand Description:** The Associate Director for Tank Farm and Solvent Recovery Operations is directly responsible ... and compliantly support the manufacturing of high-quality medicine. The Associate Director for Tank Farm and Solvent Recovery Operations provides leadership, acts… 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
- Adare Pharma Solutions (Philadelphia, PA)
- …and operate within Regulatory, Nationals laws and Health authority requirements. + Ensure compliance with GMP , internal and external requirements as well as ... Employee Recognition Programs We are seeking to hire a Director of Engineering to join our Operations team If...project delivery challenges + Lead Engineering and Maintenance FDA inspection readiness + Manage the roles and workflows of… more