Manager, Quality Assurance (m/f/d)
- Plans and manages the work of the BI Fremont Quality Assurance group; contributes to department mission statements; and provides technical leadership to ensure all necessary quality checks are completed on time, and according to SOPs.
- Identifies deviations from SOPs in manufacturing operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolution.
- Optimizes allocated department resources.
- Prepares for, manages and coordinates internal and customer audits
- Prepares for, manages and coordinates regulatory audits
- Reviews and approves of site Standard Operating Procedures to ensure compliance with cGMP requirements.
- Proposes and executes process and procedural changes to improve QA process performance, robustness, and efficiency. This may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition).
- Collaborates functionally and cross-functionally to meet organization objectives and initiatives.
- Requires a Bachelor's or higher degree from an accredited institution preferably in sciences.
- Requires a minimum of five (5) years of experience working in the Quality related aspects of a life sciences or closely related industry.
- Requires one to three (1-3) years of project management and other relevant leadership experience, including experience managing within complex matrix organizations and projects.
Boehringer Ingelheim Pharma GmbH & Co. KG
Fremont, California [USA]