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Vice President of Quality

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Mantell Associates

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Location:
United States

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Category:
Quality Control

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Contract Type:
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Salary:

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Job Description:

Mantell Associates is partnered exclusively with a fast-growing, globally operating CDMO to recruit a Vice President of Quality on a remote basis. With manufacturing sites across the United States and Europe, our client partners with some of the world’s leading pharmaceutical and biotechnology companies to deliver small molecules, biologics/mAbs and vaccines to patients globally. This is a senior leadership role stepping into an established, high-performing quality function – an opportunity for an experienced quality executive to make their mark on a truly global operation at a critical stage of the organisation’s growth. Reporting directly to the C-Suite, the VP of Quality will have full strategic and operational ownership of the quality function across all US and European manufacturing sites. You will be the ultimate quality authority for the organisation, responsible for maintaining the highest standards of GMP compliance, driving a culture of quality across a geographically distributed team, and serving as a trusted partner to clients and regulatory agencies alike. This is a remote position with regular travel to US and European manufacturing sites expected.

Job Responsibility:

  • Provide strategic direction and leadership of the global quality function across all manufacturing sites in the US and Europe
  • Own and continuously develop the Quality Management System (QMS), ensuring it is robust, scalable and fit for a multi-site, multi-modal CDMO environment
  • Drive a proactive, right-first-time quality culture across the organisation, championing quality at every level from the shop floor to the boardroom
  • Lead, mentor and develop a high-performing, geographically distributed quality team
  • Maintain GMP compliance across all manufacturing sites, covering small molecules, biologics/mAbs and vaccines
  • Oversee site quality operations, internal audit programmes and CAPA management, ensuring issues are identified, escalated and resolved effectively
  • Lead preparation for and management of regulatory inspections across all sites, acting as the primary quality representative with agencies including FDA, EMA and other relevant authorities
  • Ensure consistent application of quality standards and SOPs across all global sites
  • Provide quality oversight and input into regulatory submissions, ensuring documentation meets the expectations of FDA, EMA and other global regulatory bodies
  • Build and maintain strong, collaborative relationships with regulatory agencies, representing the organisation with authority and credibility
  • Stay ahead of the evolving regulatory landscape across all relevant modalities and geographies, proactively adapting the quality strategy accordingly
  • Act as the senior quality representative in client relationships, building trust and confidence in the organisation’s quality capabilities
  • Support business development activities by participating in client audits, due diligence processes and proposals, demonstrating the quality function as a genuine competitive differentiator
  • Partner with clients to understand their quality requirements and ensure these are embedded into manufacturing and documentation processes from the outset

Requirements:

  • Significant senior quality leadership experience within a CDMO, CRO or pharmaceutical/biotech manufacturing environment – CDMO experience strongly preferred
  • Proven track record leading quality functions across multiple sites, ideally spanning both the US and Europe
  • Broad modality experience across biologics/mAbs, small molecules and/or vaccines
  • Deep knowledge of GMP regulations and regulatory frameworks including FDA 21 CFR Parts 210/211/600, EMA GMP guidelines and ICH guidelines
  • Demonstrated experience managing regulatory agency inspections (FDA, EMA) with a strong track record of successful outcomes
  • Experience acting as a client-facing quality leader, with the gravitas and communication skills to instil confidence at senior levels
  • A strategic thinker with the operational credibility to engage meaningfully at site level
  • Proven ability to lead, develop and inspire geographically dispersed quality teams
  • Comfortable operating in a remote, fast-paced, growth-oriented environment with regular international travel
  • Bachelor’s degree or above in a relevant life sciences discipline
  • advanced degree advantageous

Additional Information:

Job Posted:
March 21, 2026

Work Type:
Remote work
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