Head of Quality / Quality Director

JR United Kingdom; Bedford; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading company in the Life Sciences sector is seeking a Head of Quality / Quality Director to drive their Quality Strategy and ensure compliance with GXP standards. The role involves leading the Quality Assurance department, developing quality policies, and maintaining relationships with regulatory authorities. The ideal candidate will have a Bachelor's degree in a scientific field and over 10 years of experience in Quality management.

Qualifications

• 10+ years of Quality management experience in Life Sciences.
• Experience with regulatory inspections and staff preparation.
• Extensive knowledge of FDA, EMEA, ICH regulations.

Responsibilities

• Define and implement a quality strategy for products.
• Lead development of GXP quality and compliance systems.
• Ensure inspection readiness and manage QA/QC teams.

Skills

Quality management

Regulatory compliance

Continuous improvement

Pharmaceutical manufacturing

Leadership

Education

Bachelor’s degree in a scientific field

Job description

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Head of Quality / Quality Director, Bedford

Client: Central Pharma

Location: Bedford, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views:

2

Posted:

23.05.2025

Expiry Date:

07.07.2025

Job Description:

Primary Objective

To drive the company’s Quality Strategy assuring compliance of GXP standards.

Responsible for translating the company’s quality strategy into tactical policies, processes, and procedures to ensure ongoing compliance with global regulatory standards.

Role Responsibilities

• Define and implement a quality strategy for licensed and non-licensed products
• Lead the development, implementation, and management of GXP quality and compliance systems and policies
• Lead the Quality Assurance department in all GXP functional areas
• Devise, recommend, and implement methods for continuous improvement of product quality and manufacturing standards within the Quality Management System
• Develop and oversee policies related to GXP compliance, including quality standards and SOPs
• Maintain relationships with regulatory authorities and trade associations, influencing future laws and standards
• Oversee the direction and evaluation of QA, QC, RA, and Validation departments
• Ensure the company is inspection-ready at all times
• Coordinate PAI readiness for new and existing customers
• Ensure products meet specifications before release
• Develop relationships with senior Quality representatives from various stakeholders
• Manage the Quality operation budget and monitor expenses
• Stay updated on industry and regulatory standards for GXP requirements
• Advise the Executive Team on Quality issues and strategic decisions
• Host audits and inspections by regulatory and client representatives
• Lead corrective actions following assessments

Additional duties may be undertaken as necessary.

Minimum Qualifications

• Bachelor’s degree in a scientific field (preferably life sciences)
• At least 10 years of substantial Quality management experience in the Life Sciences industry
• Experience in regulatory inspections and staff preparation
• Ability to present information effectively to management and boards
• Proven success in setting quality strategies and leading quality functions
• Extensive knowledge of pharmaceutical manufacturing, equipment, and testing
• Knowledge of FDA, EMEA, ICH regulations

Relationships:

Reports directly to the Board of Directors, managing the QA and QC teams, with a direct relationship with senior management.

Success Criteria:

Leading best practices, delivering quality products, excellent service, and enhancing Central Pharma’s profile in service excellence.