Quality R&D Operations Drug Substance Director

GSK•Upper Merion Township, PA

25d

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. Position Summary As the Quality R&D Operations Drug Substance Director you will lead quality oversight for drug substance activities in R&D operations at the Upper Merion R&D Pilot Plant. You will work closely with R&D scientists, manufacturing partners, regulatory colleagues and external suppliers. Your team will value clear thinking, practical problem solving, and a focus on patient safety. This role offers growth through cross-functional leadership and the chance to shape processes that accelerate safe, compliant development. You will help unite science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in a scientific or engineering discipline.
10 or more years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA).
5 years or more of experience in quality management roles for manufacturing operations.
8 or more years of experience in pharmaceutical quality, R&D quality, or related roles.
Experience with cGMP and US regulatory requirements (FDA) in a development or manufacturing environment.
Prior experience in inspection readiness and regulatory inspections.
5 or more years leading direct reports, including coaching and performance management.
Experience working with third-party suppliers or contract manufacturing organizations.

Nice To Haves

Advanced degree (MS, PhD) in chemistry, chemical engineering, pharmaceutical sciences, or a related field.
Experience with drug substance development processes such as fermentation, chemical synthesis, or biologics upstream and downstream processes.
Strong track record in quality systems implementation and process improvement.
Experience supporting clinical supply release and stability programs.
Demonstrated ability to use data to guide decisions and present to senior stakeholders.
Experience working in matrix organizations and partnering across R&D, regulatory, and supply teams.

Responsibilities

Lead quality oversight for drug substance development activities, ensuring compliance with current Good Manufacturing Practices and regulatory expectations.
Own inspection readiness and respond to regulatory questions and observations with timely, clear technical responses.
Manage a team of quality and compliance professionals. Set objectives, coach, and develop people to build capability and resilience.
Drive quality systems and processes for R&D drug substance workstreams, including change control, deviation management, CAPA, and risk assessments.
Support supplier and contract manufacturing oversight, audits, and qualification for drug substance-related activities.
Partner with cross-functional teams to enable product development milestones and timely release of clinical materials.