- 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
- ThermoFisher Scientific (Morrisville, NC)
- …**Position Overview** Lead internal audits at Thermo Fisher Scientific as an Audit Manager . Ensure compliance with global regulations. **Key Responsibilities** ... & Oversight + Create and uphold an Annual Internal Audit Plan centered on risk management for GxP...Identification + Monitor regulatory agency updates, warning letters, and inspection trends to inform internal audit focus… more
- Otsuka America Pharmaceutical Inc. (Cheyenne, WY)
- …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 (New Brunswick, NJ)
- …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
- Medtronic (Juncos, PR)
- …meet regulatory, quality, and performance requirements under FDA, ISO 13485, and GxP frameworks. The role requires technical expertise in equipment qualification and ... review protocols, reports, and risk assessments for automated systems, vision inspection systems, robotics, and digital factory technologies. + Ensure validation… more
- Pfizer (Cambridge, MA)
- …and business success. + Ensure GxP solutions are continuously audit - and inspection -ready by maintaining compliance with regulatory requirements, proactively ... in global 24-by-7 environments + Must be a successful and engaging leader/ manager , with proven capabilities in using talent and succession planning processes to… more