QA Project Manager IBEX
We are looking for a QA Project Manager for Lonza AG in Visp.
- Owns all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. This includes oversight of QC/logistic/supply chain related activities.
- Represents QA in project/tech transfer organizations for new biotech manufacturing processes.
- Coordinates QA interests during the different project phases.
- Has the authority to make quality decisions for the respective projects in internal and external meetings.
- Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required.
- Directs the investigations of customer product complaints and assures the completion of the appropriate documentation.
- Ensures an efficient cGMP compliant life cycle management of all products manufactured.
- 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.
- Authoring of SOPs
- Batch record review
- Involvement in generation of Annual Product Quality Reviews
- Participates to Quality Risk Assessments
- Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences
- Participates and supports regulatory inspections and customer audits
- Supports cGMP training programs
- Trains and mentors junior Lonza employees to better accomplish and perform in their duties as quality professionals
- Actively supports the Quality culture as a role model
- Bachelor's or master's degree in biotechnology, biology, chemistry, life science or related field
- More than 5 years of experience in the area of biopharmaceutical manufacturing, preferably in a QA function
- Strong background in cGMPs
- Broad knowledge biotechnological manufacturing processes, validation approaches and risk management
- Sound experience in representing Quality and Compliance in projects
- Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Ability to oversee project execution to identify non-compliance from quality standards.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- Excellent verbal, written and interpersonal communications skills
- Excellent organizational skills
- Excellent written and spoken English
- Knowledge of written and spoken German would be an advantage
- Strong team orientation
- Solution- oriented
Randstad (Schweiz) AG