Compliance Manager, Quality Investigation and Support (EMEA)

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

EMEA

As a Compliance Manager within the Quality Investigation and Support team, you will be involved in multiple aspects of quality assurance including management of regulatory authority inspections, misconduct investigations, assessment of serious breaches and GCP consultancy.

• Provides consultation on regulations, ICH-GCP and internal procedures to project teams and clients
• Provides support for regulatory inspections of sponsors and investigator sites
• Leads/coordinates investigation of suspected scientific misconduct cases including conduct of directed audits
• Represents quality assurance during assessment of potential serious breach cases
• Identifies issues impacting the quality and/or integrity of clinical research programs, investigates root cause of non-conformance and develops strategies to address issues
• Provides mentorship and guidance to junior auditors

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification

• 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

• Detailed knowledge of GxP and appropriate regional research regulations and guidelines
• Proficiency in a conducting GxP audits
• Excellent oral and written communication skills
• Strong problem solving, critical thinking, risk assessment and impact analysis abilities
• Confirmed experience in root cause analysis
• Flexible and able to multi-task and prioritize complex demands/workload
• Veeva experience a plus

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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