Quality R&D Operations Drug Substance Director

Role 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.

Qualifications

• Required: Bachelor’s degree in a scientific or engineering discipline.
• Required: 10 or more years of experience in Quality roles in a highly regulated environment (EMA/FDA/MHRA).
• Required: 5 years or more of experience in quality management roles for manufacturing operations.
• Required: 8 or more years of experience in pharmaceutical quality, R&D quality, or related roles.
• Required: Experience with cGMP and US regulatory requirements (FDA) in a development or manufacturing environment.
• Required: Prior experience in inspection readiness and regulatory inspections.
• Required: 5 or more years leading direct reports, including coaching and performance management.
• Required: 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.
• Preferred: Experience with drug substance development processes such as fermentation, chemical synthesis, or biologics upstream and downstream processes.
• Preferred: Strong track record in quality systems implementation and process improvement.
• Preferred: Experience supporting clinical supply release and stability programs.
• Preferred: Demonstrated ability to use data to guide decisions and present to senior stakeholders.
• Preferred: Experience working in matrix organizations and partnering across R&D, regulatory, and supply teams.