Quality R&D Operations Drug Substance Director
GlaxoSmithKline, King Of Prussia, PA, United States
Site Name:
USA - Pennsylvania - King of Prussia
Posted Date:
Mar 17 2026
At GSK, we manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance.
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.
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.
Basic Qualifications
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
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.
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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USA - Pennsylvania - King of Prussia
Posted Date:
Mar 17 2026
At GSK, we manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance.
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.
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.
Basic Qualifications
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
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.
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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