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Compliance Manager

  • Job
    Full-time
    Senior Level

AI generated summary

  • You must have a bachelor's degree, 8+ years in quality assurance, strong GxP knowledge, audit experience, excellent communication skills, problem-solving abilities, and Veeva experience is a plus.
  • You will consult on regulations, support regulatory inspections, investigate misconduct, assess quality issues, and mentor junior auditors in clinical research programs.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • 8+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
  • Detailed knowledge of GxP and appropriate regional research regulations and guidelines
  • Proficiency in a conducting GxP audits
  • Excellent oral and written communication skills
  • Strong problem solving, critical thinking, risk assessment and impact analysis abilities
  • Confirmed experience in root cause analysis
  • Flexible and able to multi-task and prioritize complex demands/workload
  • Veeva experience a plus

Responsibilities

  • Provides consultation on regulations, ICH-GCP and internal procedures to project teams and clients
  • Provides support for regulatory inspections of sponsors and investigator sites
  • Leads/coordinates investigation of suspected scientific misconduct cases including conduct of directed audits
  • Represents quality assurance during assessment of potential serious breach cases
  • Identifies issues impacting the quality and/or integrity of clinical research programs, investigates root cause of non-conformance and develops strategies to address issues
  • Provides mentorship and guidance to junior auditors

FAQs

Do we support remote work?

Yes, we do support remote work but in a hybrid format.

What is the work schedule for this position?

The work schedule for this position is standard from Monday to Friday.

What are the environmental conditions for this role?

The environmental conditions for this role are office-based.

Where is this position located?

This position is located in the EMEA region, and all EMEA applications are welcome.

What are the main responsibilities of the Compliance Manager?

The main responsibilities include providing consultation on regulations, supporting regulatory inspections, leading investigations of scientific misconduct cases, assessing potential serious breaches, identifying quality issues, and mentoring junior auditors.

What education is required for this position?

A bachelor's degree or equivalent and relevant formal academic or vocational qualification is required.

How many years of experience are needed for this role?

At least 8 years of quality assurance experience is required, or an equivalent combination of education, training, and experience.

What knowledge and skills are important for this position?

Important knowledge and skills include detailed knowledge of GxP and regional research regulations, proficiency in conducting GxP audits, excellent communication skills, strong problem-solving abilities, experience in root cause analysis, and flexibility in managing complex workloads. Experience with Veeva is a plus.

What values does Thermo Fisher Scientific promote?

Thermo Fisher Scientific promotes four core values: Integrity, Intensity, Innovation, and Involvement.

How can I apply for this position?

You can apply for this position by visiting http://jobs.thermofisher.com.

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.