QA Project Manager IBEX

Jobinhalt

• 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