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Compliance Manager

  • Job
    Full-time
    Senior Level
  • Milan

AI generated summary

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

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

What is the work schedule for the Compliance Manager position?

The work schedule is standard, Monday to Friday.

Is this position available for remote work?

Yes, the position is available in remote, office, or hybrid formats.

What qualifications are required for this role?

A Bachelor's degree or equivalent relevant formal academic/vocational qualification is required.

How many years of experience are necessary for this position?

A minimum of 8 years of quality assurance experience is required.

What kind of knowledge is essential for this role?

A detailed knowledge of GxP and appropriate regional research regulations and guidelines is essential.

Will I be required to mentor junior auditors in this role?

Yes, providing mentorship and guidance to junior auditors is part of the role.

Is experience with Veeva necessary for this position?

Experience with Veeva is a plus, but not required.

What are the key responsibilities of the Compliance Manager?

Key responsibilities include providing consultation on regulations, supporting regulatory inspections, leading investigations of suspected misconduct, and identifying issues impacting the quality of clinical research programs.

What are the company's core values?

The company's core values are Integrity, Intensity, Innovation, and Involvement.

Where is this position located?

The position is based in the EMEA (Europe, Middle East, and Africa) region.

How can candidates apply for this position?

Candidates can apply by visiting the Thermo Fisher Scientific careers website at 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.