Sterility Assurance Associate Director

GSK•Upper Merion Township, PA

About The Position

At GSK, we manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. The Sterility Assurance Associate Director is responsible for leadership, management, and implementation of the Contamination Control Programs, incl. Microbial Control strategy. The role will lead and engage in Quality Risk Management (QRM) initiatives designed to develop a robust microbial control strategy, support investigation related to such contaminations and ensure robust knowledge deployment around microbial risks and controls, as well as providing training and coaching for personnel behaviors and aseptic techniques. The leader has a team up to 2-3 SME (individual contributors) and will work closely with stakeholders in Operations, Quality Assurance, Quality Control, Engineering, Validation and Facilities. This role is also matrix leader role, part of the Quality Leadership Team and serve as an SME at UM Biopharm. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Requirements

B.A. / B.S. degree in a science such as Science/ Engineering / pharmaceutical quality.
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.
OR Ph.D. with 7+ 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.

Nice To Haves

Must have excellent technical writing skills and high attention to detail
Knowledge in cGMP, CFR and other regulations in order to assure GMP compliance.
Working knowledge of microbial risk assessments HACCP / 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.
Strong organizational skills, data analysis, and strong computer skills.
Good verbal and written communication ability and team oriented with strong interpersonal skills.
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.

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 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