- 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
- Fujifilm (College Station, TX)
- **Position Overview** The Quality Assurance (QA) Manager of Audit & Inspection will be responsible for the hosting and managing client audits, regulatory ... inspections, internal audits, and supplier assurance. The Manager will handle all associated responsibilities in compliance with...managing and reporting all aspects of a fully functional GxP -QA audit program for clinical and commercial… more
- BeOne Medicines (Emeryville, CA)
- …insights, and support risk-based decision making. The Manager /Senior Manager will collaborate cross-functionally with BeOne's internal audit operations, ... **General Description** **:** The Manager , Regulatory Compliance Readiness will report to the...Affairs and Regulatory Operations. + Contribute to compliance governance, inspection management, and risk assessment activities, including audit… more
- AbbVie (Irvine, CA)
- … regulated environment is required. + Thorough, documented understanding/knowledge of GXP regulations. . Regulatory inspection experience preferably with direct ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Senior Manager is responsible for leading the sustainment, improvement, and globalization… more
- Astellas Pharma (Sanford, NC)
- **QA Manager , Quality Risk Management** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... our website at **www.astellas.com** . **The Role** The **QA Manager , Quality Risk Management** (QRM) will be responsible for...as well as specialized QRM facilitator training across all GxP functions. + Provide guidance and support to other… more
- Sanofi Group (Waltham, MA)
- **Job title:** Manager , Quality Operations - Vaccine **Location:** Waltham, MA **About the job** The Manager of Quality Operations ensures internal and external ... with the organization. This position is defined as a Manager level position reporting directly to the Head of...Change Control. + Supports and improve (as needed) the Inspection Readiness Program. + Support and improve (as needed)… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …inspections/ customer audits. + Provide, oversee, and revise written responses to audit or inspection findings. + Practices high level of facilitations ... filling, lyophilization, final packaging, and warehousing of plasma related products. The Manager Quality Compliance will host external audits and will support and… more