Director of Quality & Regulatory Excellence

Fraser Dove International; Scotland; On-site; GBP 120,000 - 180,000; Full time

Job summary

Fraser Dove International is partnered with an established pharmaceutical manufacturer in Scotland, seeking a Director of Quality to lead Quality Operations and strengthen regulatory compliance. The role focuses on GMP stewardship, quality systems, inspections, and cross-functional leadership to support patient safety and business goals.

The ideal candidate will bring senior QA/QC management experience, a deep understanding of GMP and ICH Q10, and the ability to align quality strategy with

Qualifications

• Senior management experience in QA/QC within a regulated pharmaceutical manufacturing environment.
• Experience hosting MHRA/FDA inspections and customer audits.
• Deep knowledge of GMP and ICH Q10 requirements.
• Ability to link quality strategy with business goals and drive compliance.
• Strong leadership and stakeholder management skills.
• Degree in a relevant scientific or technical discipline.
• QP eligibility per EU/UK regulation preferred but not essential.

Responsibilities

• Set and review GMP-compliant standards across Quality Operations.
• Manage QA and QC functions in line with regulatory and business needs.
• Host regulatory inspections and customer audits.
• Identify and remediate compliance issues that could trigger major audit observations.
• Manage the Quality Management Review process and action plans.
• Improve processes within the PQS in line with ICH Q10.
• Collaborate with site leadership to make compliance a shared responsibility.

Skills

Senior management

Quality Assurance

Quality Control

GMP compliance

ICH Q10

Stakeholder management

Regulatory leadership

Education

Degree in science/engineering

QP eligibility (preferred)

Job description

Fraser Dove International is partnered with an established pharmaceutical manufacturer in Scotland, seeking a Director of Quality to lead Quality Operations and strengthen regulatory compliance. The role focuses on GMP stewardship, quality systems, inspections, and cross-functional leadership to support patient safety and business goals.

The ideal candidate will bring senior QA/QC management experience, a deep understanding of GMP and ICH Q10, and the ability to align quality strategy with