QC Director

Director, Quality Control (QC)

Lancaster, PA

Overview
A global biopharmaceutical organization is seeking a senior Director of Quality Control to lead a significant site transformation initiative. This role will oversee the evolution of a QC laboratory from a primarily low-complexity, business-as-usual testing environment into a fully capable, high-throughput analytical function supporting both commercial products and new product introductions.

Key Responsibilities

• Lead the strategic and operational transformation of the QC laboratory to support expanding manufacturing capabilities across multiple facilities
• Establish and scale new testing programs, including incoming raw materials and in-house stability testing
• Oversee method transfers for release and stability testing, ensuring robustness and successful implementation
• Direct laboratory expansion, including implementation of new technologies (e.g., UPLC, plate readers) and future-ready lab design
• Develop and execute resourcing strategies (internal hiring vs. external partners) to support increasing testing demand
• Build and lead a growing QC organization, with direct oversight across analytical, microbiology, immunology, and lab support functions
• Drive continuous improvement initiatives, including digitalization and process optimization
• Ensure compliance with GMP and regulatory requirements for commercial product testing
• Lead performance management and foster a high-accountability, growth-oriented culture during a period of significant change

Qualifications & Leadership Profile

• Proven QC leadership experience in biopharma, vaccines, or large-molecule testing environments
• Strong foundation in GMP release and stability testing, with experience supporting method transfers and assessing method robustness
• Demonstrated ability to lead and scale teams in complex, evolving environments
• Strategic yet hands-on leader who can balance planning with execution in a fast-paced setting
• Experience with lab systems (e.g., LIMS, chromatography data systems) and modern analytical technologies
• Forward-thinking, with a focus on innovation, lab design, and continuous improvement
• Strong project management and organizational skills, with the ability to drive timelines and make data-driven decisions
• High integrity, sound judgment, and a commitment to quality and patient safety
• Effective people leader who can develop talent, manage performance, and navigate organizational change

Opportunity This role offers a unique opportunity to lead a highly visible transformation and position the QC function for future growth. Success in this role can create pathways into broader site leadership or global quality roles within a complex, international organization.