Compliance Manager

ThermoFisher Scientific; Waltham (MA); Remoto; GBP 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Clinical Compliance Manager to oversee audits, assess QA processes, and report findings. You will act as a subject matter authority on audits and support QA across the clinical development portfolio.

Responsibilities include conducting complex internal/external audits, root-cause analysis, issuing management reports, and mentoring staff. Strong knowledge of GxP, ICH guidelines, and clinical quality systems is essential.

Competenze

• Thorough knowledge of applicable GxP and regional regulations.
• Extensive knowledge of the clinical trial process.
• Excellent oral and written communication skills using medical terminology.
• Training/mentoring experience.
• Strong attention to detail.

Mansioni

• Conduct internal and external audits to ensure compliance with QA processes, standards, regulatory guidelines, and client obligations.
• Identify issues impacting quality and integrity of clinical research programs; determine root causes and develop corrective actions.
• Perform technical document reviews and GxP activities for clinical development programs as needed.
• Provide audit reports to management and stakeholders.
• Plan and deliver quality services for audits; lead process/quality improvement initiatives.
• Develop tools for tracking compliance activities and analyze trends.
• Mentor junior staff and serve as project lead for group projects.

Conoscenze

GxP knowledge

Clinical trials

Communication skills

Leadership

Problem solving

Formazione

Bachelor's degree in life sciences

Strumenti

Veeva Vault

TrackWise

Descrizione del lavoro

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.