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Senior Auditor, QA Compliance Clinical Trials - home-based, EMEA

Employer
Fortrea
Location
France;Portugal;Poland;Norway;Belgium
Salary
Competitive
Start date
30 May 2023
Closing date
8 Jun 2023

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Job Details

As Senior Auditor QA Compliance, you will be responsible for meeting all internal and external audit needs, including but not limited to internal process audits and sponsor-contracted project audits in line with GCP regulations. This is an ideal role to step into for someone from a Clinical Operations background with strong interpersonal skills and a natural flair to work in a methodical, detail-orientated and organized manner.

This position is 100% home-based and can be based in any of the countries listed on this advertisement.

What else can you expect from us?
  • Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
  • Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, lunch vouchers, etc.
  • A genuine work life balance
  • Flexibility in working hours
  • A thorough onboarding with support from your personal mentor
  • A permanent employment contract
  • Excellent training and career development opportunities, as well as support with advancing your individual education
  • Strong support from your Line Manager and your team, as well as from more than 20,000 colleagues worldwide


Your responsibilities:
  • Conduct work as identified e.g. on the audit activity table.
  • Take the lead in the generation of global QA policies on both interpretation and application of regulations.
  • Provide subject matter expertise, lead and influence our QA organization by providing guidance, and support external stakeholders on specific niche regulatory topics.
  • Host external audits and inspections, e.g. regulatory inspections, strategic client meetings / audits, etc. Subsequently facilitate and review audit responses.
  • Lead the reporting of quality metrics, implement necessary corrective actions and/or process improvements via the appropriate forums (e.g. Monthly Reports, Site Quality Review, Liaison meetings).
  • Support the QA-to-QA relationship with our sponsors.
  • Deliver trainings in performance of audits (basic, intermediate, complex).
  • Participate in global quality initiatives aimed at improving compliance and/or efficiency of our QA organization.
  • Support the reporting of quality metrics and the implementation of necessary corrective actions and/or process improvements via appropriate forums (e.g. Monthly Reports, Site Quality Review, Liaison meetings).
  • Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed.
  • Act as a backup for the QA Manager and provide them with monthly activity reports


Your profile:
  • Degree in a relevant field such as pharmacology, (bio-)chemistry, biology, life sciences, health management, etc.
  • In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in drug development, acquired either at a CRO or a pharmaceutical / biotech company
  • Solid professional experience in a regulatory environment including experience in senior / lead GCP roles
  • In-depth experience with quality systems and standards in drug development
  • Excellent interpersonal and organizational skills, e.g. communication, decision making, negotiating, problem solving
  • Proven ability to apply appropriate regulatory knowledge to a variety of scenarios
  • Flexibility to travel internationally (primarily in EMEA) occasionally is a must
  • Business fluency in English (C1 and above) is a must, additional language skills are a plus


As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com .

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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