Associate Manager, Quality Assurance & Sterility Assurance

About the role

The Associate Manager, Quality Assurance & Sterility Assurance leads quality systems activities and ensures compliance with regulatory requirements, industry standards and company procedures. The role provides strategic and operational leadership for nonconformance investigations, CAPA, production quality oversight, sterilization validation, contamination control and sterility assurance programs supporting sterile medical device manufacturing.

Key responsibilities

• Supervise the identification, documentation, investigation and closure of nonconformance events, with timely root cause analysis and CAPA implementation; review and approve investigation reports against GMP and internal procedures.
• Monitor quality metrics and identify trends requiring escalation or improvement.
• Provide QA oversight and support to manufacturing, partnering with Production, Engineering, Validation and Supply Chain teams, and reviewing batch records, deviations and change controls.
• Oversee sterility assurance programs for aseptic manufacturing, ensuring compliance with cGMP, FDA, EMA and other regulations, and review environmental monitoring data, media fills and contamination control strategies.
• Collaborate with microbiology and manufacturing teams on sterility-related events and corrective actions.
• Supervise and mentor QA personnel, support internal, regulatory and customer audits, and promote a culture of quality and continuous improvement.

Required profile

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering or a related field.
• 5+ years of experience in Quality Assurance within the medical device, pharmaceutical or biotechnology industry.
• Experience leading nonconformance investigations, CAPA, change control and risk management.
• Expertise in sterility assurance for sterile medical devices, including sterilization validation, bioburden control, environmental monitoring, contamination control and microbiological risk assessment.
• Knowledge of sterilization technologies such as Ethylene Oxide (EO), Gamma Irradiation, Electron Beam and steam sterilization.
• Solid understanding of ISO 13485, ISO 11135, ISO 11137, ISO 11737, FDA Quality System Regulations and EU MDR requirements.
• Experience supporting regulatory inspections and audits.
• Fluent in French and English.