Director, QC

Responsibilities

• Provide strategic and operational leadership for the Quality Control Department within a fast-paced CDMO environment.
• Oversee QC Chemistry, Method Transfers, Stability, Raw Materials, and Logistics operations supporting GMP manufacturing and release testing.
• Drive laboratory excellence through robust quality systems, infrastructure management, and electronic platforms including LIMS, CDS, and SDMS.
• Lead the generation and review of batch release data, certificate of analysis issuance, and stability trending.
• Manage departmental budgets, headcount planning, capital projects, and resource allocation.
• Serve as a client-facing Subject Matter Expert (SME) for Analytical Technologies and QC matters during audits and regulatory discussions.
• Build and develop high-performing teams through coaching, mentoring, and succession planning.

Requirements

• Bachelor's degree in Life Sciences or a related discipline.
• Minimum of 12 years of progressive Quality Control experience within GMP-regulated pharmaceutical, biotech, or CDMO environments.
• Minimum of 6 years of proven leadership experience managing technical and operational teams.
• Strong working knowledge of cGMP regulations and quality systems.
• Demonstrated experience with laboratory electronic systems such as LIMS, CDS, and SDMS.
• Proven ability to lead complex QC operations and drive strategic initiatives in a highly regulated environment.

Preferred Qualifications

• Advanced degree (MS or PhD) in Life Sciences or Engineering.
• Multi-client, multi-product CDMO experience.
• Proficiency with JMP or other statistical analysis software.

Benefits

• Competitive base salary range of $151,360 - $170,280 plus annual performance bonus eligibility.
• Comprehensive health insurance coverage, including dental and vision.
• Paid time off and flexible spending accounts.
• 401(k) retirement plan.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and patients. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.