Quality Assurance Project Manager
vor 2 Wochen
The Quality Assurance Project Manager is responsible for ensuring the quality and compliance of biopharmaceutical products throughout their entire life cycle. This includes specifying quality requirements for technology transfers and manufacturing processes, and ensuring that manufactured products comply with national and international requirements and cGMP standards.
Key Responsibilities
- Owns all quality-related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply.
- Represents QA in project/tech transfer organizations for new biotech manufacturing processes.
- Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Performs assessments for all product-related changes, assesses relevance to regulatory filings, and decides to implement and provide change controls for approval to customers where required.
- Ensures all deviations are appropriately investigated and recorded, directs the investigations of customer product complaints, and assures the completion of the appropriate documentation.
- Identifies emerging QA relevant topics, communicates to the IBEX QA organization, and works actively on their development into new or already established Quality and Compliance strategies and/or standards.
- Trains and mentors junior Lonza employees to better accomplish and perform their duties as quality professionals.
- Supports cGMP training programs to ensure staff is being trained.
- Acts as point of contact with the Customer regarding quality-related topics and effectively engages internal cross-functional teams to address the request.
Qualification and Skills Required
- Bachelor, Master's degree or PhD in chemistry, biotechnology, life science, or related field.
- 5 years of experience in the GMP-regulated pharmaceutical industry; preferably in a QA role.
- General knowledge of biopharmaceutical manufacturing processes and analytical methods.
- Experienced in interaction with health authorities (Swissmedic, FDA etc.).
- Solution-oriented; Strong fact-based decision maker.
- Ability to oversee project execution to identify non-compliance with quality standards.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- Structured, focused, and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated, and dynamic drive.
- Strong team orientation with excellent verbal, written, and interpersonal communication skills.
About Lonza
At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world.
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