Director, CMC Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic quality leadership as the Quality representative on multidisciplinary teams, collaborating with Process and Analytical Development, MSAT, Regulatory Affairs, Supply Chain, and external partners.

• Ensure that quality decisions throughout the lifecycle of cell therapy products are scientifically sound and risk-based, covering development, technology transfer, characterization, validation, and continued process verification (CPV).

• Review and authorize CMC regulatory submissions, development and validation documentation, technical reports, comparability assessments, and regulatory responses.

• Assist with health authority inspections and interactions, along with other due diligence activities.

• Propel continuous improvement of CMC Quality systems, processes, and organizational capabilities.

• Lead the development and lifecycle management of product quality and risk-based control strategies consistent with QbD, QRM, ICH, and global regulatory expectations.

• Offer Quality oversight of CQAs, CPPs, CMAs, in-process controls, release strategies, and continued process verification.

• Evaluate the quality impact of changes in manufacturing, analytical processes, facilities, suppliers, and other processes.

• Supervise product, raw material, in-process, release, and stability specifications, along with analytical acceptance criteria.

• Provide strategic Quality oversight for internal Analytical Development laboratories and outsourced QC operations, encompassing testing, analytical method lifecycle management, investigations, deviations, OOS/OOT events, CAPAs, and quality/compliance metrics.

• Oversee GMP sample lifecycle, retain programs, reference standards, and product traceability.

• Lead Quality oversight of sterility assurance programs, contamination control, aseptic processing, environmental monitoring, cleanroom qualification, microbiological controls, and compliance with Annex 1.

• Provide Quality oversight for CTLs, CDMOs, and other external partners through vendor qualification, audits, governance, quality agreements, technology transfer, manufacturing support, investigations, and change management.

⛳️ Requirements

• A Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Microbiology, Biochemistry, or a related scientific field; an advanced degree is preferred.

• Over 10 years of progressive Quality experience in biotechnology, biologics, or advanced therapies, including a minimum of 5 years in support of cell therapy or ATMP products.

• Proven expertise in supporting autologous and/or allogeneic cell therapy manufacturing, analytical testing, and lifecycle management.

• Strong background in CMC Quality, including QbD, QRM, control strategy development, QC oversight, analytical method lifecycle management, specifications, stability, sterility assurance, contamination control, process development, technology transfer, and process validation.

• Extensive knowledge of GMP, GCP, ICH guidelines, FDA, EMA, and global regulatory requirements applicable to cell and gene therapies.

• Experience in supporting regulatory inspections, Health Authority interactions, and maintaining inspection readiness.

• Exceptional leadership, communication, and cross-functional collaboration skills, with a proven ability to influence both internal and external stakeholders.

• Demonstrated capability to manage competing priorities, lead complex technical quality initiatives, and make informed, risk-based decisions in a fast-paced, evolving environment.

• Experience in implementing contamination control strategies in line with EU GMP Annex 1.

• Experience in supporting regulatory submissions, including INDs, BLAs, MAAs, and post-approval lifecycle changes.

🏝️ Benefits

• Approximately 30–40% travel to CDMOs, Contract Testing Laboratories, suppliers, company locations, and regulatory or business meetings.