- Sanofi Group (Framingham, MA)
- **Job Title:** Audit and Inspection Manager **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... to get started? **Main Responsibilities:** + Developing and implementing an annual self- inspection plan + Reviewing the internal audit reports before submission… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- …this role is to support the Global Quality Management team with an emphasis on GxP audit coordination. In addition to these activities, the role would include ... Audit Related Activities** + Coordinate, support, and manage GxP Audit activities Organize audit ...+ Support the establishment and maintenance of the required Audit / Inspection Documentation + Identify process gaps and… more
- AbbVie (North Chicago, IL)
- … regulated environment is required. + Thorough, documented understanding/knowledge of GXP regulations. . Regulatory inspection experience preferably with direct ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager is responsible for leading the sustainment, improvement, and globalization… more
- Bristol Myers Squibb (Indianapolis, IN)
- …of CAPAs. + Maintain audit records and ensure timely communication of audit outcomes. + Support regulatory inspections and inspection readiness activities. + ... Provide guidance and training on audit processes and GxP compliance expectations. +...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- Merck (North Wales, PA)
- …to monitor trends from system audit findings and assist in response to audit and inspection findings of GCD and GRACS IT systems **Education:** + Bachelor's ... with regulatory requirements and follow our SDLC policy. Clinical Systems Quality Manager will be responsible to ensure our clinical systems are developed, validated… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …or more prioritized CoEs within the Global Quality Operations organization-such as Inspection Readiness, Audit Effectiveness, or other strategic focus areas. ... The Senior Manager , Centers of Excellence (CoEs) is responsible for...development and execution of one or more CoEs (eg, Inspection Readiness, Audit Effectiveness) aligned with global… more
- Bristol Myers Squibb (Devens, MA)
- …QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit . + Provides quality and ... KPIs , and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and… more
- Bristol Myers Squibb (Princeton, NJ)
- …clinical enablement, and the agility to pivot to GLP bioanalysis (PK/PD/ADA) under GxP principles when program needs require it. The incumbent will wire in quality ... across lab operations, data, and vendor ecosystems - so we are inspection -ready, compliant, and outcomes-driven for patients. The role partners closely with… more