Quality R&D Operations Drug Substance Director
GlaxoSmithKline, King Of Prussia, PA, United States
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
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 Benefits Summary Learn more about the comprehensive benefits program GSK offers U.S. employees.
Accommodations 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.
Equal Opportunity Employer 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.
Important Notice to Employment Businesses / Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/ agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Transparency Requirements for U.S. Licensed Healthcare Professionals Please note that if you are a U.S. Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state U.S. Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.
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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
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 Benefits Summary Learn more about the comprehensive benefits program GSK offers U.S. employees.
Accommodations 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.
Equal Opportunity Employer 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.
Important Notice to Employment Businesses / Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/ agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Transparency Requirements for U.S. Licensed Healthcare Professionals Please note that if you are a U.S. Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state U.S. Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.
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