Compliance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• Join Us as a Clinical Compliance Manager - Make an Impact at the Forefront of Innovation
• The Clinical Compliance Manager is responsible for the assessment, management, and reporting of different kinds of audits. The ideal candidate will serve as a subject matter authority on audits handling and support other activities related to QA across the clinical development portfolio.

What You'll Do:

• •Conduct complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and/or client contractual obligations.
• •Identification of issues impacting the quality and/or integrity of clinical research programs, determination of root cause of non- conformance and development of strategies to address issues.
• •Upon request performance of technical document review and other GxP practice activities in support of clinical development programs.
• •Provision of audit reports to management.
• •Planning and delivery of quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Leads process/quality improvement initiatives.
• •Develops tools and other materials for tracking compliance management activities and analyzes trends.
• •Mentors less experienced staff and serves as project lead for group projects. Creates formal networks with key contacts across the department

• Education & Experience Requirements:
• •Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• •5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.
• •Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations.
• •Proven experience in CAPA, root cause analysis, and deviation management.
• •Demonstrated ability to communicate complex compliance issues clearly and effectively.
• •Comfortable working in a matrix organization and managing cross-functional customers.
• •Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is a plus.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Knowledge, Skills, Abilities:
• •Thorough knowledge of applicable GxP and appropriate regional regulations
• •Extensive knowledge of the clinical trial process
• •Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• •Training/mentoring experience
• •Strong attention to detail
• •Effectively works independently or in a team environment
• •Highly developed problem solving skills, risk assessment and impact analysis abilities
• •Strong leadership skills
• •Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
• •Strong digital literacy; ability to learn and become proficient with appropriate software
• •Proven flexibility and adaptability
• •Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• •Veeva QMS experience 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.