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.
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