Senior QA Projects Lead – Biopharma, cGMP Compliance

Lonza; Oberwallis; Sur place; Vertraulich; Plein temps

Avantages offerts par ce poste

Agile career path

Inclusive workplace

Compensation programs that recognize高

Résumé du poste

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist to own quality responsibilities for biopharmaceutical manufacturing processes used in clinical and commercial supply. You will serve as QA in project teams, ensuring cGMP compliance and timely change controls.

You will review records, drive deviations investigations, and support regulatory filings while mentoring junior staff and advancing QA strategies. Fluency in English with German a plus.

Qualifications

• Academic degree in Chemistry/ Biotechnology/ Life Science or any related field.
• Solid experience in the GMP regulated pharmaceutical industry is required; preferably in a QA role.
• General knowledge of biopharmaceutical manufacturing processes and analytical methods.
• Experienced in the interaction with health authorities (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.
• 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.
• Business fluent English is required, good German skills - an advantage

Responsabilités

• Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
• Responsible for review and final release of records like SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Perform assessments for all product-related changes, assesses relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.
• Ensure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation.
• Identify emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards.
• Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals. Support cGMP training programs to ensure staff is being trained.

Connaissances

QA leadership

Regulatory liaison

Biopharma know-how

Team collaboration

Formation

Chemistry/Biotech/Life Science degree

Description du poste

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist to own quality responsibilities for biopharmaceutical manufacturing processes used in clinical and commercial supply. You will serve as QA in project teams, ensuring cGMP compliance and timely change controls.

You will review records, drive deviations investigations, and support regulatory filings while mentoring junior staff and advancing QA strategies. Fluency in English with German a plus.