Quality R&D Operations Drug Substance Director

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.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- 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.

Why you?

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

- 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.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

- 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.

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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 - usrecruitment.adjustments@gsk.com

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.

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