Interim Quality Director

Mantell Associates; Italia; Remoto; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A well-established Pharmaceutical company is seeking an experienced Interim Quality Director to lead QA operations on a remote, full-time contract. This role involves managing in-house and external QA staff to ensure compliance with GMP standards. Candidates should have extensive experience in pharmaceutical quality assurance and demonstrate strong communication and leadership skills. The position starts mid-October and is committed for 18 months.

Competenze

• 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.

Mansioni

• Lead and oversee the Quality Assurance department, managing in-house QA staff and external vendors.
• Develop, review, and enforce quality systems, policies, and procedures.
• Conduct vendor qualification and oversight, assessing contractor performance.

Conoscenze

GMP compliance

Leadership

Quality Assurance

Vendor management

Communication skills

Descrizione del lavoro

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 [phone].

PDx MI External Manufacturing Manager - Europe