Director of Quality

Mantell Associates is partnered exclusively with a globally operating CDMO to recruit a Director of Quality for their large-scale manufacturing site on the East Coast. With a broad portfolio spanning biologics/mAbs and small molecules, and an international network of manufacturing facilities, our client is a trusted partner to some of the world’s leading pharmaceutical and biotechnology companies.

Reporting directly into the VP of Quality, this is a senior site-level leadership role within an established and high-performing quality organisation – ideal for an experienced quality professional ready to take ownership of quality operations at a complex, large-scale CDMO site.

As Director of Quality, you will be the most senior quality leader on site, responsible for the full breadth of quality operations across a 500+ employee manufacturing facility. You will drive GMP compliance, oversee QC operations, lead regulatory interactions and serve as the primary quality partner to clients – all whilst developing and maintaining a strong quality culture across the site.

Director of Quality – Responsibilities:

Quality Management & Compliance

• Own and drive the site QMS, ensuring all systems, processes and documentation are robust, inspection-ready and aligned with global quality standards
• Lead site GMP compliance across biologics/mAb and small molecule manufacturing operations, ensuring adherence to FDA regulations and ICH guidelines
• Oversee the site CAPA programme, deviation management and change control processes, ensuring issues are investigated thoroughly and resolved effectively
• Drive a proactive, right-first-time quality culture across all site functions, from manufacturing and QC through to supply chain and engineering

QC Oversight

• Provide strategic and operational oversight of the site QC function, ensuring analytical testing, raw data review and results reporting meet the highest standards of accuracy and compliance
• Partner with QC leadership to ensure laboratory operations are fully compliant, inspection-ready and continuously improving
• Oversee out-of-specification (OOS) and out-of-trend (OOT) investigations, ensuring robust root cause analysis and appropriate corrective actions

Regulatory & Submissions

• Serve as the site quality authority for all regulatory matters, leading preparation for and management of FDA inspections and any other relevant agency interactions
• Provide quality oversight and input into regulatory submissions, ensuring site-level documentation and data packages meet agency expectations
• Monitor the evolving regulatory landscape and proactively update site quality systems and practices to maintain compliance

Client Partnership & Audits

• Act as the senior quality representative for client relationships at site level, building strong partnerships and instilling confidence in the site’s quality capabilities
• Lead and manage client audits and internal audit programmes, ensuring the site is consistently audit-ready
• Collaborate with clients to understand and embed their quality requirements into site operations, serving as a key quality contact throughout the manufacturing lifecycle
• Support business development activities by representing the quality function during client due diligence visits and proposals

Leadership & Team Development

• Lead, mentor and develop a large, multidisciplinary quality team across QA and QC functions
• Partner closely with site leadership and the VP of Quality to align site quality strategy with broader organisational goals
• Foster a culture of accountability, continuous improvement and professional development across the quality organisation

Director of Quality – Requirements:

• Significant quality leadership experience within a CDMO, pharmaceutical or biotechnology manufacturing environment – CDMO experience strongly preferred
• Proven experience leading site-level quality operations at scale, ideally within a large, complex GMP manufacturing facility
• Hands-on experience across both biologics/mAb and small molecule modalities
• Deep knowledge of FDA GMP regulations (21 CFR Parts 210/211/600) and relevant ICH guidelines
• Demonstrated experience managing FDA inspections with a strong track record of successful outcomes
• Proven QC oversight experience, with a solid understanding of analytical operations and laboratory compliance
• Strong client-facing skills with the ability to build credibility and trust at a senior level
• Exceptional leadership and people management skills, with experience developing large, diverse quality teams
• Strategic thinker with the operational presence to engage credibly at all levels of a large manufacturing site
• Bachelor’s degree or above in a relevant life sciences discipline; advanced degree advantageous
• Based or willing to relocate to the East Coast of the United States

This is an outstanding opportunity to take on a high-impact Director of Quality role at a globally recognised CDMO, with the backing of an established team, a world-class VP of Quality and the resources of a large, growing organisation. You will have genuine ownership of quality at site level whilst being part of a broader global quality leadership community – a rare combination of autonomy and support.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.