Director, Quality Control

Position Responsibilities:
- Provide strategic leadership and oversight of all QC activities supporting DS and DP manufacturing, including release testing, stability programs, and in-process testing.
- Partner with AS&T to ensure robustness and lifecycle management of the analytical control strategy, including method qualification, validation, transfer, and performance monitoring.
- Oversee analytical, microbiological, and environmental monitoring programs to ensure GMP compliance and alignment with the site contamination control strategy.
- Ensure data integrity, accuracy, and reliability of all QC data in accordance with regulatory expectations.
- Establish and maintain inspection readiness, including hosting regulatory inspections and responding to health authority inquiries.
- Drive timely and thorough investigations of OOS, OOT, and atypical results, including root cause identification and effective CAPA implementation.
- Ensure appropriate specifications, test methods, and acceptance criteria are established and maintained throughout the product lifecycle.
- Oversee QC laboratory operations, including resource planning, capacity management, and organizational capability development.
- Partner cross-functionally with Manufacturing, QA, MSAT, AS&T, and Regulatory Affairs to support batch release, process improvements, and regulatory submissions.
- Lead continuous improvement initiatives to enhance laboratory efficiency, compliance, and right-first-time performance.
- Develop and monitor QC performance metrics, identify trends, and drive actions to improve performance and compliance.
- Build and develop a high-performing QC organization, fostering quality culture and technical excellence.
- Serve as a Subject Matter Expert (SME) on business sub-teams to address analytical/microbiological issues and timeliness.

Education and Experience:
- Bachelor’s degree in chemistry, Biology, or a related scientific discipline (advanced degree preferred).
- Minimum 12 years of pharmaceutical/biotechnology QC experience, including 8 years in leadership roles.
- Strong leadership experience building and leading high-performing technical teams.
- Experience managing environmental monitoring and contamination control strategies in GMP manufacturing environments.
- Experience supporting DS and DP manufacturing in GMP environments.
- Proven regulatory inspection success and audit management track record.
- Proven experience with laboratory method lifecycle management.
- Experience implementing or optimizing laboratory systems and processes (preferred).

Technical Skills / Core Competencies:
- Deep expertise in GMP regulations applicable to QC laboratories supporting ATMPs.
- Strong knowledge of analytical techniques (e.g., q/rt/ddPCR, flow cytometry, ELISA, cell-based assays, microbiological methods) for DS/DP testing.
- Strong understanding of data integrity principles and regulatory expectations (ALCOA+).
- Ability to operate effectively in a matrixed, cross-functional environment.
- Strong risk-based, science-driven problem-solving skills.
- Excellent communication skills; ability to influence at site and executive levels.
- Strong project management skills.