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.
This is a remote, full-time contract role starting mid-October, focused on managing teams, ensuring GMP compliance, and working with contractors and vendors.
Interim Quality Director - 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
Interim Quality Director - 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)20 3854 7700.