Director, Quality Control

POSITION SUMMARY

The Director, Quality Control provides strategic and operational leadership for all Quality Control (QC) activities supporting drug substance (DS) and dug product (DP) manufacturing at the site. This role is accountable for ensuing the generation of accurate, reliable, and compliant analytical data to support product release, stability, and lifecycle management in accordance with global GMP requirements.

The Director QC oversees all QC functions, including analytical, microbiological, and environmental monitoring programs, and ensures alignment with the overall control strategy. This role ensures inspection readiness data integrity, and continuous improvement of QC systems and processes. As a member of the site Quality Leadership Team, the Director partners cross-functionally with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence.

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 the robustness and lifecycle management of the analytical control strategy including method qualification, validation, transfer, and performance monitoring.

• Oversee analytical, microbiological, and environmental monitoring programs, ensuring compliance with GMP requirements and 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, ensuring appropriate 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, identifying trends and driving actions to improve performance and compliance.

• Build and develop a high performing QC organization, fostering a strong quality culture and technical excellence.

• Participates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issues

• Other responsibilities and duties as the company may from time-to-time assign

EDUCATION AND EXPERIENCE

• Bachelor’s degree in chemistry, Biology or related scientific discipline required, advanced degree preferred.
• Minimum 12 years of experience in pharmaceutical or biotechnology QC, with. 8 years in leadership roles.
• Strong leadership skills with experience building and leading high-performing technical teams.
• Experience managing environmental monitoring and contamination control strategies in GMP manufacturing environments.
• Experience supporting DS & DP manufacturing in GMP environments.
• Proven track record of regulatory inspection success and audit management.
• 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) and their application tin DS/DP testing.
• Strong understanding of data integrity principles and regulatory expectations (ALCOA+).
• Ability to operate effectively in a matrixed, cross-functional environment.
• Strong problem-solving skills with a risk-based and science-driven approach.
• Excellent communication skills with the ability to influence at site and executive levels.
• Strong project management skills.