Associate Manager, Quality Assurance & Sterility Assurance

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The Associate Manager, Quality Assurance & Sterility Assurance is responsible for leading quality systems activities and ensuring compliance with regulatory requirements, industry standards, and company procedures.

This 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. The position plays a critical role in ensuring product quality, patient safety, regulatory compliance, and operational excellence.

Key Responsibilities Nonconformance Management

• Supervise the identification, documentation, investigation, and closure of nonconformance events.
• Ensure timely root cause analysis and implementation of corrective and preventive actions (CAPA).
• Review and approve investigation reports to ensure compliance with GMP and internal procedures.
• Monitor quality metrics and identify trends requiring escalation or improvement.

Production Quality Support

• Provide Quality Assurance oversight and support to manufacturing operations.
• Partner with Production, Engineering, Validation, and Supply Chain teams to resolve quality issues.
• Review batch records, deviations, and change controls to ensure product disposition decisions are made appropriately.
• Support process improvements while maintaining regulatory compliance.

Sterility Assurance

• Oversee sterility assurance programs for aseptic manufacturing processes.
• Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements.
• Review environmental monitoring data, media fills, and contamination control strategies.
• Collaborate with microbiology and manufacturing teams to investigate sterility-related events and implement corrective actions.

Leadership and Compliance

• Supervise and mentor QA personnel to ensure effective performance and professional development.
• Support internal audits, regulatory inspections, and customer audits.
• Promote a culture of quality and continuous improvement.
• Ensure adherence to quality policies, procedures, and documentation practices.

Qualifications

• 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.
• Strong experience leading nonconformance investigations, CAPA, change control, and risk management activities.
• Demonstrated 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.
• Strong leadership, problem-solving, and communication skills.
• Fluent in French and English.