Manager, Quality Systems and Risk Management
About the role
What You'll Do
The Quality Systems and Risk Management Manager reports to the Sr. Manager of Quality Systems Management and plays a key supporting role in the execution and continuous improvement of the organization's risk management program and Quality Management System (QMS). This individual contributes across two core areas: Owning and leading formal risk management through risk assessments, risk registers, and the application of ICH Q9 and FMEA frameworks, and Maintaining and improving the QMS. They also play a hands-on role in key quality processes such as Annual Product Quality Review (APQR) compilation and the generation of quality metrics for Quality Management Reviews (QMRs), working closely with the Sr. Manager to ensure compliance with GxP regulatory standards and company policies.
The ideal candidate is detail-oriented, highly organized, and eager to develop deep expertise across quality systems in a commercial-stage biopharmaceutical environment and bring a collaborative mindset and the ability to work effectively across functions to support quality deliverables and timelines.
Responsibilities
- Own and drive formal risk management activities across the organization by leading risk assessments, maintaining risk registers, and applying risk frameworks such as ICH Q9 and FMEA. Integrate risk-based thinking into day-to-day QMS activities and serve as the subject matter expert for risk management methodology.
- Support the maintenance and continuous improvement of the QMS. Participate in QMS improvement initiatives, including the onboarding and implementation of new Veeva Vault QMS modules, and serve as the procedural subject matter expert for assigned QMS processes, maintaining the associated documentation to reflect current practice and regulatory expectations.
- Manage the preparation and compilation of APQR reports. Play a hands-on role in the APQR process by supporting cross-functional data collection, compiling...