Senior Quality Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day, enabling our customers to make the world healthier, cleaner and safer.

DESCRIPTION

Within our Clinical Trials Division (CTD), we partner with pharmaceutical and biotechnology companies to accelerate clinical development through contract packaging, storage and distribution services. Our Horsham site specialises in the packaging, storage and distribution of clinical trial supplies under ambient, refrigerated, frozen and ultra-low-temperature conditions, together with commercial autoinjector assembly.

Operating within a highly regulated, inspection-ready environment, we maintain the highest standards of quality, regulatory compliance and product integrity to support our customers throughout the clinical supply chain and into commercial production.

As our business and regulatory landscape continues to evolve, we are seeking a Quality Compliance Specialist to provide technical leadership across key compliance programmes, ensuring our Horsham site continues to meet the requirements of EU GMP (EudraLex Volume 4), FDA 21 CFR Parts 210 & 211 (cGMP), ISO 13485 and other applicable regulatory requirements.

Position Summary:

This is an exciting opportunity for an experienced quality professional to lead specialist compliance programmes within a growing Clinical Trials business. As the site's technical Subject Matter Expert for Data Integrity, ISO 13485 and Controlled Drug compliance, you will provide technical leadership across multiple functions, helping to ensure our quality systems remain compliant, effective and inspection ready. Working collaboratively with Quality, Manufacturing, Engineering, Validation and Supply Chain teams, you will influence how regulatory requirements are interpreted and embedded into site processes while driving continual improvement across key compliance programmes. This position reports to the Senior Quality Assurance Manager.

Working Arrangements:

This is a hybrid position based at our Horsham site. Due to the collaborative and operational nature of the role, the successful candidate will normally be expected to work on site a minimum of four days per week, with flexibility to work remotely for up to one day per week, subject to business requirements.

Key Responsibilities:

Regulatory Compliance & Governance:

• Provide technical leadership to ensure the Horsham site maintains compliance with applicable regulatory requirements and remains inspection ready
• Lead specialist compliance programmes supporting EU GMP (EudraLex Volume 4), FDA 21 CFR Parts 210 & 211 (cGMP), ISO 13485 and other applicable regulations
• Monitor changes in legislation and regulatory guidance, assessing business impact and leading implementation of appropriate improvements
• Act as the site's Subject Matter Expert during regulatory inspections, customer audits and compliance initiatives
• Partner with process owners across the business to strengthen regulatory compliance and governance

Data Integrity:

• Lead the site's Data Integrity Programme, ensuring the integrity, reliability and governance of GxP data throughout its lifecycle
• Develop and continuously improve the site's Data Integrity framework and governance
• Lead Data Integrity risk assessments and provide technical guidance to support validation, change management and investigations
• Drive improvements that embed Data Integrity principles into systems, processes and behaviours

Management of Compliance Projects:

• Coordinate the implementation and ongoing maintenance of compliance projects (e.g. ISO 13485, controlled drug)
• Develop procedures and provide specialist guidance to support these compliance programmes and maintain audit readiness

REQUIREMENTS

What We're Looking For:

We're looking for someone who combines strong regulatory knowledge with the ability to influence, collaborate and drive improvement across the business.

You'll bring:

• Experience within a GMP-regulated pharmaceutical, biotechnology or medical device environment
• A good understanding of EU GMP, FDA cGMP and/or ISO 13485 requirements
• Experience interpreting regulations and translating them into practical business solutions
• Strong communication and stakeholder management skills, with the ability to influence across multiple functions
• A proactive, analytical approach with a passion for continuous improvement

It would be advantageous if you also have:

• Experience with Data Integrity principles and governance
• Experience of Controlled Drug compliance and Home Office licensing
• Experience supporting regulatory inspections or customer audits

Core Competencies:

• Technical leadership
• Regulatory interpretation
• Stakeholder engagement
• Programme ownership
• Continuous improvement
• Risk management
• Analytical thinking
• Influencing without authority

How will you get here?

• Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values.
• Takes ownership, accepts responsibility for your actions and always make sound decisions with solid communication skills.
• Curious and in a learning stance. You will research, compile, summarize, and analyse information to formulate correspondence and respond to various inquiries from internal and external customers.
• Demonstrates an adaptive and flexible work style shown to be effective working across varied types of clients, senior level leaders and front-line team members.
• Connect with peers in UK and Global Sites to create a robust network.
• Ensure compliance with cGMP, Quality Systems and training requirements are met in line with
  business need.
• Appreciation and respect for diversity, cultures, and professional workplace standards.