QA Validation Manager

Location: Visp

Start date: Immediately

End date: 31.12.2026

Key Accountabilities

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters, and global regulatory guidelines.
• Collaborate closely with MSAT, Manufacturing, and clients to ensure processes are supported by scientifically sound and documented evidence.
• Maintain oversight of validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitization processes.
• Oversee qualification requirements of related equipment and systems.
• Manage continuous process verification (CPV) and process validation activities.
• Act as a key QA point of contact for product transfer activities and related validation strategies.
• Prioritize and manage workload in alignment with line manager requirements and site goals.
• Perform change control and deviation impact assessments.
• Support investigations of non-conformities.
• Demonstrate understanding of cell and gene manufacturing processes, equipment, product control strategies, and low bioburden environmental assurance.
• Provide technical expertise in the review and approval of SOPs, protocols, reports, change controls, deviations, and other GMP records for QA closure.
• Participate in audits and inspections to demonstrate compliance with European and U.S. FDA regulations.
• Support continuous improvement initiatives.
• Serve as the subject matter expert (SME) for SOPs related to Process Validation and Cleaning Validation.
• Review and approve validation documentation, including Process Validation, Cleaning Validation, and Computer System Validation (CSV) documentation.
• Participate in risk assessments.
• Support the Data Integrity Program.
  

Qualifications

• Bachelor's degree in Science, Biotechnology, or a related field.
• 5-7 years of experience in the pharmaceutical industry within a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification.
• Experience with change controls, deviation management, and non-conformity investigations.
• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Proficiency in English; German is a plus.