Quality Systems & Data Associate Director

GSK•King of Prussia, 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 Associate Dircetor, Quality Systems & Data provides leadership to a team of Quality professionals critical in overseeing Data Integrity and Governance, Training & Training compliance, Quality Management System (QMS) deployment, and providing quality oversight to the Digital Strategy (SMART Manufacturing). The role also includes responsibility for defining and driving the site Quality Improvement Plan and the Quality Culture and support the site Quality Leadership Team for driving Data Analytics & GPS. The Associate Director, Quality Systems & Data reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT). This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide leadership and strategy for site data integrity & governance program working closely with central and site teams. Responsible for creating and driving the Quality digital strategy (SMART manufacturing) in collaboration with site and central functions. Manages updates to site quality systems including VQMS, MERP through appropriate change management procedures. Lead the GSK Quality Management System deployment through effective execution. Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes. Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs. Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives and drive initiatives for Quality Culture at site Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals. Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems. Provide leadership and direction to a team of 5-15 quality professionals, fostering a culture of quality and compliance. Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.

Requirements

B.A. / B.S. degree in a science such as Science/ Engineering / pharmaceutical quality.
10+ years of industrial experience in a commercial pharmaceutical manufacturing facility.

Nice To Haves

In-depth experience in quality systems, including validation, compliance, and running a high volume, rapid turnaround operation.
Strong technical understanding of industry and science practices related to the business.
Prior experience with leading significant improvement programs.
Fully versed in GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements for validation and operations, and analytical and stability functions.
Strong interpersonal and leadership skills.
Solid team player able to function within team-based organization.
Strong verbal and written communication skills.
Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, finance and EHS.
Able to priorities and decide appropriate course of actions.
Effective at implementing decisions

Responsibilities

Provide leadership and strategy for site data integrity & governance program working closely with central and site teams.
Responsible for creating and driving the Quality digital strategy (SMART manufacturing) in collaboration with site and central functions.
Manages updates to site quality systems including VQMS, MERP through appropriate change management procedures.
Lead the GSK Quality Management System deployment through effective execution.
Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes.
Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.
Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives and drive initiatives for Quality Culture at site
Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals.
Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.
Provide leadership and direction to a team of 5-15 quality professionals, fostering a culture of quality and compliance.
Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.