- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill an Associate Director of Quality Auditing position. This position will be responsible for providing professional expertise, ... leadership, oversight and planning for the Regeneron Quality Auditing function, with primary emphasis on GMP , IT and Quality audits that may impact GMP … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... activities that will ensure a state of continuous GMP compliance in Regeneron and to build inspection readiness...and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and… more
- ThermoFisher Scientific (Boston, MA)
- …biopharmaceutical company, all while maintaining full-time benefits. Reporting to the Associate Director , CMC QC Stability, will be responsible for ... addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems,...supporting various GMP stability testing programs and Quality Systems, including handling stability Quality Events,… more
- Fujifilm (College Station, TX)
- …Biotechnologies Texas (FDBT) is seeking ** Quality Assurance (QA) Validation - Associate Director ** to oversee the review and approval of commissioning, ... providing strategic leadership to the validation team. **Job Title:** Quality Assurance (QA) Validation, Associate Director...with cross functional teams and management to instill a " Quality Culture" by coaching personnel on GMP … more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- …pharmacovigilance, post market surveillance, GMP Auditing and Supplier Management. The Associate Director , Quality Management and QA Site Leader ensures ... audits/inspections and provides leadership during regulatory authority visits. The Assoc. Director leads quality programs, continuous improvement efforts, and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- The Associate Director Quality System is responsible for monitoring the effectiveness of the GxP Quality Management Systems regarding CAPA, Deviations, ... support eQCMS (TrackWise or similar system) enhancements in collaboration with Global Quality Systems. Provide guidance and perform a risk assessment for global CAPA… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality ... other tasks as assigned (eg, final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations… more
- Catalent Pharma Solutions (Manassas, VA)
- ** Associate Director , Quality ** **Job Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... as a member of the Site Leadership Team the ** Associate Director , Quality ** is accountable...as needed. + Review and ensure compliance with plant GMP 's, HACCP, sanitation and pest control procedures and standards.… more
- BeiGene (Hopewell, NJ)
- **_General Description:_** Establish a stability program in Quality Control for clinical and commercial phase biologics products in accordance to FDA/EU regulations, ... and procedures. Oversee and manage stability studies to deliver scientifically sound GMP test data in accordance to predefined protocols. Oversee the Quality… more
- Lilly (Indianapolis, IN)
- …trial medicines, while also reducing costs and environmental impact. The Associate Director Engineering Facilities/Utilities provides leadership and direction to ... engineering team responsible for plant and environmental control utilities. The Associate Director Engineering Facilities ensures that engineering deliverables… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory/Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory/ quality risks and opportunities… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director (AD), Program Quality is responsible for building and sustaining the quality relationship with partners ... customer relationship management or alliance management * Experience in quality assurance in a GMP environment *...* Experience in quality assurance in a GMP environment * Experience in developing and implementing regulatory… more
- Lilly (Lebanon, IN)
- …to enable a successful startup into GMP manufacturing operations._ **Responsibilities** The Associate Director - Head of TS/MS Lab will lead a technically ... development. In this role you will work collaboratively with peers in the quality control laboratory, engineering, development and quality assurance. + Assisting… more
- Lilly (Indianapolis, IN)
- …The Director is responsible for managing the activities of Quality Assurance personnel supporting Indy Parenteral Operations, with respect to regulatory ... taking into consideration quality , compliance and business aspects, escalate critical quality issues + Review/Approve GMP documents (examples include but not… more
- Merck (Durham, NC)
- …related to tech transfer and process stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory ... **Job Description** The Associate Director - Purification Technology Lead...for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and… more
- Merck (Durham, NC)
- …the safest and most compliant operation around the network. EMSS has an Associate Director opening for the Vaccine Manufacturing Facility (VMF) maintenance team. ... provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world With our core principle of Safety… more
- Fujifilm (College Station, TX)
- **Position Overview** The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department, responsible for ... Quality Control processes are in full compliance with established quality systems and GMP regulations. + Collaborate with the Quality Assurance team to… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting ... of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …role:** At Takeda's Round Lake aseptic fill/finish and Packaging facility, the Associate Director , Process Engineering will lead a cross-functional team ... closely with Manufacturing, Maintenance, Automation, Reliability, Validation, Manufacturing Science, Quality , Business Excellence and Supply Chain to ensure operational… more
- Lilly (Lebanon, IN)
- …the development, review, approval, and delivery of training meet corporate and site quality standards. Additionally, the Associate Director will oversee ... medicines, while also reducing costs and environmental impact. The Associate Director - LRL L&D Strategic Site...knowledge of and/or experience in a regulated environment (ie, GMP , GxP) + Knowledge of LRL business and structure… more