Interim Quality Director

Overview

Mantell Associates is partnered with a well-established Pharmaceutical company, who is seeking an experienced Interim Quality Director to lead their QA operations over an 18-month project.

Responsibilities

• Lead and oversee the Quality Assurance department, managing in-house QA staff and external vendors / contractors to uphold GMP standards across manufacturing operations


• Develop, review, and enforce quality systems, policies, and procedures to ensure product quality, regulatory compliance, and continuous improvement


• Oversee deviation, non-conformance, CAPA, change control and quality assurance investigations; drive root cause analysis and ensure timely corrective and preventive actions


• Conduct vendor qualification and oversight: assess contractor performance, audit suppliers and ensure contracted quality obligations are met


• Manage audits and inspections readiness, including regulatory authority inspections, internal audits, and external audits, ensuring documentation is inspection-ready


• Collaborate with cross-functional teams (Manufacturing, Regulatory, Supply Chain, Technical / Engineering) to align quality expectations and resolve quality-related issues impacting operations


• Monitor quality metrics, performance KPIs, and report to senior leadership on QA status, risk areas, and compliance health

Requirements

• Extensive experience in pharmaceutical Quality Assurance within a GMP manufacturing environment


• Previous leadership experience managing QA teams and working closely with external vendors and contractors


• Proven track record of driving quality compliance and audit readiness in similar senior quality roles


• Strong knowledge of European GMP regulatory frameworks; experience with Italian regulatory expectations is an advantage


• Excellent communication, leadership, and stakeholder management skills; able to lead remotely and ensure high performance across geographies


• Available to start mid-October; committed full-time (5 days / week) for the full 18-month contract duration

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

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