Director Global Product Quality

Director, Global Product Quality | Windsor | Hybrid – 1 day per week

A senior Quality leadership opportunity for an experienced pharmaceutical professional to lead delegated Global Product Quality activities , ensuring robust GMP/GDP compliance, effective Quality Systems and reliable supply of high-quality products across international markets.

Reporting to the Senior Director, you will provide operational leadership across a broad range of Quality activities, working closely with global teams, affiliates, suppliers and external partners. You will also act as deputy to the Senior Director when required.

Key responsibilities include:

• Lead GMP/GDP Quality Assurance, Quality Systems, document management, vendor management and affiliate support activities
• Ensure products meet relevant quality, safety, efficacy and Marketing Authorisation requirements
• Oversee CAPAs, change controls, non-conformances, complaints, validation activities and Quality documentation
• Support supplier audits, internal audits, regulatory inspections and inspection readiness
• Provide Quality oversight of contract manufacturers, supporting continuity and security of supply
• Oversee batch release, product complaints, recalls and distribution activities across European affiliates
• Support QC, analytical testing, stability and certification requirements
• Drive Quality improvement initiatives and contribute to wider Global Quality projects and goals
• Provide guidance on regulatory and legislative changes and support relationships with Regulatory Authorities
• Fulfil Responsible Person (RP) for Wholesale and/or Responsible Person for Import (RPi) responsibilities where appointed

Requirements :

• QP-level training with 20+ years’ pharmaceutical Quality experience
• Strong QA, QC and Production experience with extensive GMP/GDP knowledge
• Experience working with contract manufacturers, suppliers and external partners
• Strong understanding of UK and European pharmaceutical regulations
• Experience relevant to RP Wholesale and/or RPi responsibilities
• Commercial mindset with excellent communication and stakeholder management skills
• Hands-on, collaborative approach with strong ownership and the ability to drive Quality initiatives

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