Senior Quality Compliance Specialist
Thermo Fisher Scientific · Horsham, UK
QualityFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks an experienced Quality Compliance Specialist for their Clinical Trials Division in Horsham. The role provides technical leadership on regulatory compliance programmes, data integrity, and controlled drug compliance across a GMP-regulated site serving pharmaceutical and biotech customers.
What they're looking for
- Experience in GMP-regulated pharmaceutical, biotechnology, or medical device environment
- Understanding of EU GMP, FDA cGMP, and/or ISO 13485 regulatory requirements
- Ability to interpret regulations and translate them into practical business solutions
- Strong communication and stakeholder management skills across multiple functions
- Proactive analytical approach with passion for continuous improvement
- Data Integrity principles and governance experience (advantageous)
- Controlled Drug compliance and Home Office licensing experience (advantageous)
What you'll be doing
- Lead specialist compliance programmes for EU GMP, FDA cGMP, ISO 13485 and other applicable regulations
- Manage the site's Data Integrity Programme, ensuring GxP data governance throughout its lifecycle
- Monitor regulatory changes and lead implementation of required business improvements
- Act as Subject Matter Expert during regulatory inspections and customer audits
- Coordinate compliance projects and develop procedures to maintain audit readiness
Privacy & handoff
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