Director of Quality Job at Mantell Associates (Massachusetts)

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

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Director of Quality

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