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Director of Quality

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Mantell Associates

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Location:
United States , Massachusetts

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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
  • 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

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

Additional Information:

Job Posted:
March 21, 2026

Work Type:
On-site work
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