Sterility Assurance Associate Director

The Sterility Assurance Associate Director is responsible for leadership, management, and implementation of the Contamination Control Programs, including the Microbial Control strategy. The role will lead and engage in Quality Risk Management (QRM) initiatives designed to develop a robust microbial control strategy, support investigations related to contamination, and ensure robust knowledge deployment around microbial risks and controls, as well as providing training and coaching for personnel behaviors and aseptic techniques. Responsibilities Lead a team of experts and is responsible to establish and maintain microbial controls program ensuring that overall quality standards around microbial risks and controls are met. Lead, facilitate, write and/or approve 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 with 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 (e.g., rapid methods and automation) in alignment with GSK global strategy. Basic Qualifications B.A./B.S. degree in a science such as Science/Engineering/pharmaceutical quality. 12+ years of sterile pharma, biopharmaceutical, manufacturing or biologics industry-based experience with knowledge of Process Microbiology (risk assessment) and/or QC Microbiology, Contamination Control, Sterility Assurance systems or Operational Quality or MSAT. OR Ph.D. with 10+ years of sterile pharma, biopharmaceutical, manufacturing or biologics industry-based experience with knowledge of Process Microbiology (risk assessment) and/or QC Microbiology, Contamination Control, Sterility Assurance systems or Operational Quality or MSAT. Preferred Qualifications Must have excellent technical writing skills and high attention to detail. Knowledge in cGMP, CFR and other regulations to assure GMP compliance. Working knowledge of microbial risk assessments, FMEA is desirable. Demonstrated knowledge of Quality by Design and risk management approaches. Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities. Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization. Must be performance and delivery driven. Strong organizational skills, data analysis, and strong computer skills. Good verbal and written communication ability and team-oriented with strong interpersonal skills. Demonstrated successful team management and/or matrixial leadership with strong influencing skills across multiple stakeholders. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at View email address on click.appcast.io. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr