QA Manager Sterility Assurance

About the job

On behalf of our client, a company in the biopharmaceutical industry, we are looking for a QA Manager Sterility Assurance to lead and improve the sterility assurance programme of a production site located in the north of the canton of Vaud.

As the site referent for contamination control and aseptic processes, you will be involved in the manufacturing activities of active substances and finished products. You ensure their compliance with cGMP requirements and Annex 1 of the European GMPs, in collaboration with operational and quality teams.

QA Manager Sterility Assurance

Your responsibilities

• Lead the site sterility assurance programme and ensure its continuous improvement.

• Maintain and develop the Contamination Control Strategy (CCS) in accordance with Annex 1 requirements.

• Ensure quality supervision of aseptic manufacturing operations and promote good contamination control practices.

• Supervise environmental monitoring (EM) programmes, including trend reviews, risk assessments and management of adverse trends.

• Ensure quality supervision of GMP utilities monitoring: water for injection (WFI), purified water, clean steam, gases and HVAC systems.

• Lead the governance of aseptic process simulations (APS / Media Fill): strategy, approval, review of results and associated investigations.

• Ensure implementation and maintenance of risk analyses and HACCP approaches applied to aseptic and low microbial load processes.

• Review and approve deviations, investigations, CAPA, change controls and risk assessments impacting sterility assurance.

• Collaborate with Production, Quality Control, Engineering, Validation and Quality Assurance to anticipate and reduce contamination risks.

• Contribute to inspection preparation and represent the Sterility Assurance function with health authorities.

• Promote a strong quality culture and lead initiatives to improve microbiological quality systems.

Your profile

• Higher education in microbiology, biotechnology, pharmaceutical sciences, engineering or a related scientific discipline.

• At least 8 years of experience in sterility assurance, microbiology, quality assurance or aseptic production in the pharmaceutical or biotechnological industry.

• Proven experience in sterile manufacturing and contamination control.

• Mastery of cGMP, Annex 1 of the European GMPs and quality risk management methodologies.

• Expertise in the following areas:

  • Environmental monitoring and utilities monitoring.

  • Aseptic processes and APS / Media Fill programmes.

  • Development and maintenance of a CCS.

  • Qualification of cleanrooms and personnel.

• Ability to lead cross-functional projects and unite stakeholders from different functions.

• Leadership, rigour and the ability to make decisions and communicate them clearly.

• Fluent French and English, both written and spoken.