Sterility Assurance Associate Director

About the role

The Sterility Assurance Associate Director is responsible for leading and managing the Contamination Control Programs, including Microbial Control strategy. This role involves leading and engaging in Quality Risk Management (QRM) initiatives, supporting contamination investigations, ensuring robust knowledge deployment around microbial risks and controls, and providing training and coaching for personnel behaviors and aseptic techniques.

Responsibilities

• Lead a team of experts to establish and maintain microbial controls program ensuring overall quality standards around microbial risks and controls are met.
• Lead, facilitate, write and/or approve on risk assessments for microbial controls and contamination investigations.
• Write the Contamination Control Strategy for the facilities in partnership with MSAT and ensure periodic review.
• Provide coaching and mentoring to contamination investigation teams and ensure well-written contamination investigation reports.
• Partner with training team and / or relevant SMEs to develop and deliver training solutions and build capabilities at site associated to microbial risk and controls, as well as clean room behaviors and aseptic techniques.
• Participate in Quality Council and holistically assess and report, with cross-functional team, microbial trends from the various quality systems.
• Critically analyze data to recommend opportunities for robustness improvements through authoring EM/Utilities trend reports with QC Micro.
• Support with team the implementation of projects to drive to desired future state (where applicable use of quality system workflows change control, CAPA, Quality Improvement Plan may be employed).
• Support new product/new process/new equipment design for microbial control and review/approve microbial risk assessments for new products and processes.
• Support Quality Control team as needed to develop capabilities for EM program and testing.
• Support Operations to develop Cleaning and Disinfection program supported by disinfectant studies.
• Ensure disinfectants used at site are robustly qualified.
• Supports Operations as needed to develop Gowning and Qualification program including aseptic techniques.
• Front during inspection for all CCS strategies.
• Drive strategy, qualification and implementation for new QC microbiology method modernization (eg. rapid methods and automation) in alignment with GSK global strategy.

Qualifications

• B.A./B.S. degree in a science such as Science/Engineering/Pharmaceutical Quality, or Ph.D. with 10+ years of sterile pharma, biopharmaceutical, Manufacturing or biologics industry-based experience with gained knowledge of Process Microbiology (risk assessment) and/or QC Microbiology, Contamination Control, Sterility Assurance systems or Operational Quality or MSAT.