QA Compliance Manager - Clinical Trials

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

As a Compliance Manager within the Audits and Inspections team, you will be responsible for managing all aspects of GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients. The Compliance Manager leads and/or reviews complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Majority of the work is focused on the APAC region; however, inspection support in other regions is also in scope.

What you will do

• Provide consultation to project teams and clients on GxP audit and inspection readiness, preparation, management, and follow-up activities.
• Serve as the primary point of contact for audit and inspection-related discussions with clients.
• Support client audits and GxP regulatory authority inspections of the company, investigator sites, and sponsors, including risk assessment and mitigation strategies, training of involved staff and conducting mock interviews, internal preparation, pre-inspection / mock inspection activities, review of documentation requested by inspectors, audit/inspection hosting and facilitation, and post-inspection follow-up.
• Lead, review, and approve reports for a variety of client, internal, or GxP audits and regulatory inspections.
• Support project teams in investigating root causes of findings/non-conformances and in developing CAPAs to address identified issues; follow up on action implementation, effectiveness checks, and the collection and review of supporting evidence.
• Contribute to lessons learned discussions and participate in company-wide improvement initiatives.
• Develop and effectively share guidance and reference information, repositories, and communication channels including policies, procedures, guidance documents, or quality management systems training.
• Lead process improvement initiatives and collaborate with a variety of cross functional staff to ensure appropriate execution and completion and continuous improvement.
• Develop tools and other materials for tracking of compliance management activities and analyse trends.
• Mentor less experienced staff and serve as project lead for group projects.
• Identify and resolve issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develop strategies to address issues.
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings.

Education & Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Preferred Fields of Study: Biology, Pharmacy or related
• 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
• 1+ years of experience in management/leadership roles preferred

Knowledge, Skills, Abilities

• Extensive knowledge of GxP, with GCP required, along with a strong understanding of applicable regional clinical research regulations, requirements and guidelines, along with applicable global guidelines / requirements
• Proven expertise and experience in quality management systems and regulatory frameworks, conducting internal audits, supporting, hosting/management of client audits and GxP regulatory inspections across the region
• Proven experience in root cause analysis
• Strong problem solving, critical thinking, risk assessment and impact analysis abilities
• Detail oriented with ability to deal with multiple and changing priorities
• Exceptional communication (verbal and written) and presentation skills (including appropriate use of medical and scientific terminology)
• Strong negotiation and conflict management skills
• Ability to effectively mentor and provide direction to staff and to work independently or in a team environment
• Strong organizational and time management skills, flexibility and ability to multi-task and prioritize complex demands/workload
• Advanced proficiency in Microsoft Office Suite and compliance-related software. Veeva QMS experience is a plus

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.