Senior Compliance Specialist

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Oversee all facets of GxP regulatory authority inspections at CRG, investigator sites, and client locations.

• Offer guidance to project teams and clients regarding GxP inspection readiness, preparation, management, and follow-up processes.

• Act as the main liaison for client-related discussions on inspections.

• Assist in inspections through risk assessment and mitigation strategies, staff training, mock interviews, internal preparation, pre-inspection activities, documentation evaluation, hosting, facilitation, and post-inspection follow-up.

• Aid in investigating root causes of non-conformance and the development of Corrective and Preventive Actions (CAPAs).

• Monitor the implementation of actions, conduct effectiveness checks, and gather and review supporting evidence.

• Participate in lessons-learned discussions and contribute to company-wide improvement initiatives.

• Provide mentorship and direction to junior team members.

• Primarily focus on EMEA while also supporting inspections in other regions.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Over 5 years of experience in quality assurance, or a comparable mix of education, training, and experience.

• In-depth knowledge of GxP, with a requirement for Good Clinical Practice (GCP) expertise.

• Strong grasp of relevant regional research regulations and guidelines.

• Proven experience in managing GxP inspections, with mandatory GCP inspection experience.

• Exceptional verbal and written communication skills.

• Strong capabilities in problem-solving, critical thinking, risk assessment, and impact analysis.

• Demonstrated experience in root cause analysis.

• Ability to juggle multiple tasks, prioritize complex workloads, and maintain flexibility.

• Experience with Veeva QMS and auditing is a plus.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Meaningful work that contributes to scientific excellence and global health, cleanliness, and safety.

• A passionate and innovative workplace.