Director, Quality Control

Role Overview

The Director, Quality Control – Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. This role will ensure timely, compliant, and scientifically sound oversight of release, stability, characterization, in-process, and method lifecycle activities performed at CMOs and contract testing laboratories.

This role is responsible for ensuring that all QC systems, analytical methods, and testing programs are inspection-ready and aligned with global regulatory expectations for commercial biologics. The Director will partner cross-functionally and externally to enable successful PPQ execution, analytical method validation, regulatory approval, and commercial launch readiness.

Key Responsibilities

QC Strategy, Clinical Execution & Commercial Readiness

• Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
• Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
• Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
• Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
• Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.

Analytical Methods, Validation & Lifecycle Management

• Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
• Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
• Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
• Drive continuous improvement of analytical control strategies and testing programs through data trends and risk-based approaches.