Senior Quality Compliance Specialist

Work Schedule

Environmental Conditions

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 opportunity for a proactive Quality Compliance Specialist to provide practical technical leadership for ISO 13485 compliance and quality-system improvement at our Horsham site. The primary focus is ensuring ISO 13485 requirements are understood, applied and sustained in packaging, assembly and related manufacturing processes, supporting continued certification and inspection readiness. 

Working closely with Packaging Operations, Quality, Engineering, Validation and Supply Chain, you will be a visible presence in operational areas: observing processes, engaging technicians and team leaders, identifying compliance risks and helping implement effective, sustainable improvements. You will also support and develop the site Data Integrity programme and build expertise in other regulatory compliance areas, including Controlled Drugs, with appropriate training. 

The role requires the confidence to present technical matters to cross-functional groups, constructively challenge practices and work independently while building strong relationships across the site. 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: 

ISO 13485 Compliance  (essential)  

• Provide technical leadership for the site accreditation of ISO 13485 compliance programme, supporting continued certification, audit readiness and continual improvement of the Quality Management System. 

• Interpret and apply ISO 13485 requirements to packaging, assembly, manufacturing support and associated quality processes; work with process owners to establish effective controls and objective evidence of compliance. 

• Plan and support ISO 13485 internal accreditation, certification and surveillance audits; coordinate appropriate responses, remediation, effectiveness verification. 

 Quality Management Systems: (essential) 

•  Identify and implement improvements through direct engagement with operational colleagues, including process observation and practical coaching at the point of work. 

•  Monitor changes to relevant standards and guidance, assess site impact and coordinate implementation of necessary updates. 

•  Participate in and progressively lead risk assessments for equipment, computerised systems and processes, working with established subject matter experts as required.  

Data Integrity: (desirable)  

•  Support the ongoing governance and continual improvement of the site Data Integrity programme, applying ALCOA+ principles to GxP records, systems and operational practices. 

•  Support the identification, prioritisation and tracking of Data Integrity risks and remediation activities. 

•  Provide practical guidance and training to operational teams on data integrity. 

•  Contribute to Data Integrity metrics, trend analysis and improvement actions. 

Broader Regulatory Compliance and Projects:  (desirable)   

•  With appropriate training, to support the site Controlled Drug compliance programme, including relevant procedures, inspections and Home Office licensing activities; prior specialist experience is not required. 

•  Develop clear procedures, meaningful compliance measures and accessible training materials; present recommendations and progress to operational teams and site leadership. 

REQUIREMENTS 

What We're Looking For:  

We are looking for a hands-on, self-motivated quality professional with proven experience applying, supporting and implementing ISO 13485.  

Having the confidence to engage colleagues throughout operational areas and the ability to translate requirements into practical improvements requirements.  

We do not expect expertise in every specialist regulatory programme on joining but the knowledge and implementation of ISO 13485 is essential. 

Experience of pharmaceutical packaging, clinical trial supplies or combination-product/medical-device assembly. 

Core Competencies: 

•  ISO 13485 technical application and QMS improvement 

•  Operational quality engagement and risk-based judgement 

•  Data Integrity fundamentals and learning agility 

•  Independent ownership and prioritisation 

•  Clear presentation and cross-functional influence 

•  Teamwork, coaching and continuous improvement