Compliance Manager

Work Schedule

Environmental Conditions

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 Youll 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:
Bachelors 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.