Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 8+ years of GMP Quality experience in pharmaceuticals, particularly in late-stage drug product development and validation.
• Experience with sponsor-side CMO oversight, including clinical- and commercial-stage drug substance activities.
• Proficient in process validation (PPQ) and regulatory submissions for late-stage products.
• Preferred experience in inspection readiness, both domestically and internationally.

Responsibilities

• Lead quality oversight for CMOs in pre-clinical, clinical, and commercial manufacturing.
• Own and manage quality for commercial-stage drug substance activities and related processes.
• Act as QA subject matter expert on deviations, CAPAs, change controls, and documentation.
• Review and approve CMO documentation, batch records, and test data while managing product dispositions.
• Support quality reviews of regulatory submissions and participate in inspection readiness activities.
• Collaborate with CMC, Supply Chain, and Analytical Development as the QA representative.
• Maintain and update quality metrics and GMP standard operating procedures.

Benefits

• Opportunity for professional growth in a cutting-edge regulatory environment.
• Engagement across multiple functions within the organization, enhancing cross-departmental skills.
• Direct involvement in high-stakes drug development processes, impacting patient outcomes.