GSK · 1 week ago
Quality R&D Operations Drug Substance Director
King of Prussia, PA
Full-time
Onsite
Director/Executive
10+ years expGSK is a global biopharma company that manufactures and supplies high-quality medicines and vaccines. The Quality R&D Operations Drug Substance Director will lead quality oversight for drug substance activities in R&D operations, ensuring compliance and managing a team to drive quality systems and processes.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
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
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase