GCP Global Quality & Compliance Manager
Location- Remote- with attendance in the office once a month based in Hertfordshire
Role- Permanent, Full-Time
Company Overview
Our client is a rapidly growing international consultancy specialising in product development, regulatory affairs, quality assurance, and compliance services for the pharmaceutical, biotechnology, and healthcare sectors. The organisation partners with a diverse range of clients, from emerging biotech companies to established global pharmaceutical organisations, providing strategic and operational expertise across the product development lifecycle.
With an established international presence spanning multiple regions, the company has built a strong reputation for delivering high-quality scientific, regulatory, and compliance solutions that support innovation and accelerate the development of healthcare products worldwide.
The Opportunity
We are seeking an experienced and highly motivated GCP Quality professional to join a growing global consulting organisation as a GCP Global Quality & Compliance Manager. This is a permanent, full-time position offering the opportunity to play a key role in delivering quality and compliance services across a diverse international client portfolio.
This position is ideal for an ambitious individual with a strong GCP auditing background who is looking to take on increased responsibility, contribute to strategic quality initiatives, and support the continued growth of a global quality and compliance function.
Key Responsibilities
* Lead the delivery, oversight, and management of GCP Quality and Compliance services across multiple client programmes.
* Plan and conduct GCP audits, including vendor qualification audits, project audits, system audits, live process monitoring, and inspection readiness assessments.
* Support clients in identifying, investigating, and resolving quality and compliance issues arising from audit findings.
* Perform Quality Management System (QMS) gap assessments and develop quality documentation including Standard Operating Procedures (SOPs), policies, work instructions, and quality plans.
* Provide sponsor oversight services for clinical trials, ensuring effective management of CROs, vendors, and investigational sites while maintaining compliance with applicable regulations and sponsor expectations.
* Develop and deliver GCP training programmes tailored to client requirements.
* Support the implementation and continuous improvement of quality systems and compliance frameworks.
* Drive quality improvement initiatives and promote operational excellence across client engagements.
* Lead CAPA development, issue management, root cause investigations, and quality risk assessments.
* Act as a subject matter expert and escalation point for quality and compliance matters.
* Manage project deliverables while maintaining a strong focus on quality, timelines, and client satisfaction.
* Contribute to business growth through consultancy support, technical review activities, and quality leadership.
Essential Qualifications & Experience
* Bachelor's degree in a Life Sciences discipline or related scientific field.
* Advanced degree (MSc or PhD) in a biomedical, pharmaceutical, or scientific discipline preferred.
* Minimum of 5 years' experience conducting GCP audits within clinical research, pharmaceutical, biotechnology, CRO, or consultancy environments.
* GCP Certification
Demonstrated experience performing:
* Clinical trial audits
* CRO audits
* Vendor qualification audits
* System audits
* Inspection readiness audits
* GCP training and compliance activities
* Strong experience authoring and reviewing SOPs and quality documentation.
* Comprehensive knowledge of ICH-GCP guidelines and applicable global regulatory requirements.
Skills & Competencies
* Excellent organisational, planning, and project management skills.
* Strong analytical, problem-solving, and decision-making abilities.
* Proven ability to manage multiple priorities and deliver high-quality work within tight timelines.
* Effective stakeholder management and client-facing communication skills.
* Experience mentoring, coaching, and supporting the development of colleagues.
* Ability to work independently while collaborating effectively within global teams.
* Strong written and verbal communication skills.
* Proficiency with Microsoft Office applications and quality management systems.
Additional Requirements
* Willingness to travel within the UK, Europe, and internationally when required.
* Flexible and adaptable approach within a fast-paced consultancy environment.
* Strong commitment to quality, compliance, and continuous improvement.
Why Join?
This opportunity offers the chance to work within a rapidly growing international consultancy environment where quality and compliance are central to business success. The successful candidate will have significant exposure to a wide variety of clinical development programmes, regulatory environments, and client organisations while contributing directly to strategic quality initiatives and business growth.
This role provides an excellent platform for career progression, leadership development, and increased responsibility within a dynamic and expanding global organisation.