Director of Quality

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

Do you have the senior quality leadership experience to set high standards within pharmaceutical manufacturing?

Can you build a culture where Good Manufacturing Practice (GMP) compliance and quality are shared responsibilities?

Are you ready to strengthen pharmaceutical quality systems while supporting wider business goals?

Fraser Dove International is partnering exclusively with an established pharmaceutical manufacturing organisation. Operating in Scotland, they are committed to maintaining high standards of quality, regulatory compliance and patient safety.

Our client is seeking an experienced leader to manage Quality Operations and strengthen regulatory compliance across the site.

Discover more about our Director of Quality opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Director of Quality, you will be measured against the following objectives:

• Maintain an effective Quality Operations function that meets Good Manufacturing Practice (GMP), regulatory and business requirements.
• Strengthen the Pharmaceutical Quality System in line with International Council for Harmonisation (ICH) Q10 requirements, using performance management and continuous improvement to raise quality standards.
• Build a strong culture of compliance through effective people leadership, inspection readiness and close collaboration with senior stakeholders.

What you will do:

As the Director of Quality, your duties and responsibilities will include:

• Set and review Good Manufacturing Practice (GMP) compliant standards across Quality Operations.
• Manage the Quality Assurance and Quality Control functions in line with regulatory and business requirements.
• Host regulatory inspections and strategic customer audits.
• Identify, remediate and elevate compliance issues that could result in critical or major audit observations.
• Manage the Quality Management Review process and associated action plans.
• Improve processes within the Pharmaceutical Quality System in line with International Council for Harmonisation (ICH) Q10 requirements.
• Collaborate with site leadership and department heads to make regulatory compliance and quality assurance a shared responsibility.

What you will bring:

These are the skills and experience you will need to succeed as the Director of Quality:

• Extensive senior management experience within Quality Assurance and Quality Control in a regulated pharmaceutical manufacturing environment.
• Experience hosting Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) inspections and customer audits.
• Deep knowledge of Good Manufacturing Practice (GMP), Pharmaceutical Quality Systems and International Council for Harmonisation (ICH) Q10 requirements.
• Proven ability to link quality strategy with business goals while improving compliance and quality performance.
• Strong people leadership, communication and stakeholder management skills.
• A degree in a relevant scientific or technical discipline.
• Eligibility to act as a Qualified Person (QP) under the Human Medicines Regulations or European Union Directive 2001/83/EC is preferred but not essential.

Got what it takes?