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Quedan 3 Días : Interim Quality Director...

Mantell AssociatesBucaramanga, CO

Hace 11 horas

Descripción del trabajo

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 Italianregulatory 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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Quedan Director • Bucaramanga, CO