QA Manager - Sterlity Assurance

Antaes Consulting; Lausanne; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

Antaes Consulting in Lausanne is seeking a senior Sterility Assurance Lead to oversee the program for Drug Substance and Drug Product and drive robust contamination control across manufacturing operations.

The role requires deep knowledge of cGMP, EU GMP Annex 1, Environmental Monitoring, and CCS; you will partner with Manufacturing, QA, Engineering and Validation to ensure compliant aseptic practices and risk management.

Qualifikationen

• Degree in Microbiology, Biotechnology, Pharmaceutical Sciences, Engineering or related scientific discipline.
• Minimum 8 years of experience in Sterility Assurance, Microbiology, Quality Assurance or aseptic manufacturing.
• Demonstrated experience in sterile manufacturing and contamination control programs.
• Thorough knowledge of cGMP requirements, EU GMP Annex 1 and Quality Risk methodologies.
• Strong expertise in environmental Monitoring programs, utilities Monitoring, aseptic Processing, APS/Media Fill programs, contamination Control Strategy (CCS), cleanroom qualification and personnel qualification
• Proven ability to lead cross-functional initiatives and influence stakeholders.
• Fluent in French and English, written and spoken.
• Strong communication, leadership, and decision-making skills.

Aufgaben

• Lead and oversee the Sterility Assurance program for Drug Substance and Drug Product.
• Maintain and improve the Contamination Control Strategy (CCS) per EU GMP Annex 1.
• Ensure quality oversight of aseptic manufacturing activities and promote compliant aseptic behaviors and contamination control practices.
• Provide quality oversight for Environmental Monitoring programs, including periodic trend reviews, risk assessments and adverse trends management.
• Ensure quality oversight of monitoring programs for GMP utilities, including WFI, PW, Clean Steam, gases and HVAC systems.
• Lead the governance of Aseptic Process Simulations, including strategy, approval, review of outcomes and associated investigations.
• Ensure effective implementation and maintenance of risk analysis and HACCPs within low bioburden and aseptic manufacturing processes.
• Review and approve deviations, investigations, CAPAs, change controls and risk assessments impacting sterility assurance.
• Partner with Manufacturing, Quality Control, Engineering, Validation, and Quality functions to proactively identify and mitigate contamination risks.
• Drive continuous improvement initiatives related to sterility assurance, contamination control, and microbiological quality systems
• Support inspection readiness activities and represent the Sterility Assurance function during Health Authority inspections.
• Foster a strong quality culture and promote right-first-time and compliant behaviors throughout the organization.

Kenntnisse

Cross-functional leadership

Communication skills

Decision making

French & English fluency

Ausbildung

Degree in Microbiology, Biotechnology, Pharmaceutical Sciences, Engineering or related scientific discipline

Jobbeschreibung

• Lead and oversee the site Sterility Assurance program supporting both Drug Substance and Drug Product manufacturing.
• Maintain and continuously improve the site Contamination Control Strategy (CCS) in accordance with EU GMP Annex 1 requirements.
• Ensure quality oversight of aseptic manufacturing activities and promote compliant aseptic behaviors and contamination control practices.
• Provide quality oversight for Environmental Monitoring (EM) programs, including periodic trend reviews, risk assessments and adverse trends management.
• Ensure quality oversight of monitoring programs for GMP utilities, including WFI, PW, Clean Steam, gases and HVAC systems.
• Lead the governance of Aseptic Process Simulations, including strategy, approval, review of outcomes and associated investigations.
• Ensure effective implementation and maintenance of risk analysis and HACCPs within low bioburden and aseptic manufacturing processes.
• Review and approve deviations, investigations, CAPAs, change controls and risk assessments impacting sterility assurance.
• Partner with Manufacturing, Quality Control, Engineering, Validation, and Quality functions to proactively identify and mitigate contamination risks.
• Drive continuous improvement initiatives related to sterility assurance, contamination control, and microbiological quality systems
• Support inspection readiness activities and represent the Sterility Assurance function during Health Authority inspections.
• Foster a strong quality culture and promote right-first-time and compliant behaviors throughout the organization.

REQUIREMENTS

• Degree in Microbiology, Biotechnology, Pharmaceutical Sciences, Engineering or related scientific discipline.
• Minimum 8 years of experience in Sterility Assurance, Microbiology, Quality Assurance or aseptic manufacturing within the pharmaceutical or biotechnology industry.
• Demonstrated experience in sterile manufacturing and contamination control programs.
• Thorough knowledge of cGMP requirements, EU GMP Annex 1 and Quality Risk methodologies.
• Strong expertise in environmental Monitoring programs, utilities Monitoring, aseptic Processing, APS/Media Fill programs, contamination Control Strategy (CCS), cleanroom qualification and personnel qualification
• Proven ability to lead cross-functional initiatives and influence stakeholders.
• Fluent in French and English, written and spoken.
• Strong communication, leadership, and decision-making skills.

Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 10 consulting companies in Switzerland. We have over 300 experienced engineers who share our passion.

Present in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas:

• Organizational and transformation consulting
• Information systems management

By joining our teams, you will discover:

• A dynamic team with a start-up mindset
• Personalized support and career development follow-up
• Opportunities to expand your network through exciting challenges
• A company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025

We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted.

Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.