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Senior Quality Assurance Manager

vor 2 Wochen


Visp Valais, Schweiz 49f0f97d-d5f8-4d44-97b3-a4b5969eb725 Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

We are seeking an Senior Sterility Assurance & Contamination Control Lead to lead the comprehensive contamination control strategy within a sterile manufacturing operations. The successful candidate will be a recognized expert in GMP-regulated sterile environments, playing a critical role in ensuring the highest standards of product quality and regulatory compliance.

Your responsibilities will include:

  • Proven experience in a GMP-regulated sterile manufacturing environment, including for example aseptic processing, terminal sterilization, or advanced therapy products
  • Demonstrated leadership in designing, implementing, and continuously improving a robust, site-wide Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and global regulatory expectations (FDA, EMA, MHRA, PIC/S)
  • Strong technical background in cleanroom design, qualification, and control, including state-of-the-art aseptic facility builds or major upgrades (HVAC zoning, material/personnel flows, RABS/isolator integration)
  • Experience with regulatory remediation in sterile manufacturing - leading or supporting the recovery of compliance status, requalification of clean areas, and system-based corrective actions under regulatory oversight
  • Demonstrated expertise in leading and resolving complex sterility assurance investigations: environmental or product contamination events, sterility test failures, media fill excursions, and utility-based contamination
  • Deep understanding of aseptic operator qualification programs, aseptic technique training, gowning qualification, and personnel monitoring in controlled environments
  • Familiar with quality oversight during tech transfer, facility startup, and process validation phases, ensuring sterility assurance is designed in from the outset
  • Strong experience in cross-functional risk assessments (e.g., FMEA, HACCP) to proactively identify and mitigate microbial risks throughout the product lifecycle
  • Experienced in preparing for and managing regulatory inspections and client audits with a focus on sterility assurance systems, contamination control, and aseptic practices