Qa à France

Pay Competitive

Employment type Full-Time

Req#: 2337356

As our new Associate Director, Client Audit & Inspection Management, you will assure all Inspection Readiness (IR) relevant systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guideline, as well as fulfill our clients’ and our internal requirements. You will provide direction and support for our IR operational groups and study teams, assist with the leadership and management of global Regulatory Agency inspections and client audits, and manage a dedicated and highly skilled team of Fortrea QA professionals.

If you are looking for a position in which you can take on responsibility and leverage your QA expertise just as much as your managerial and interpersonal skills, this is an excellent opportunity!

Your work location can be 100% home-based anywhere in the UK – or, if you prefer, based out of one of our offices in Maidenhead or Leeds.

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, charity donations matching, public transport discounts etc.

• A genuine work life balance

• Flexibility in working hours

• A thorough onboarding with support from your personal mentor

• A permanent employment contract with Fortrea

• 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:

• Manage, train and develop staff in Inspection Readiness function; provide ongoing direction and support to Fortrea operation and study staff for inspection readiness and activities.

• Design and implement solutions and process improvements which enhance inspection readiness and management activities at Fortrea, including creation and revision of inspection readiness tools and Controlled Documents.

• Lead the development and conduct of internal and external (e.g., investigator sites, vendors) training relating to inspection readiness and management.

• Manage client and internal communications when inspection announcements are received.

• Direct inspection preparation activities for specific inspections to ensure study teams and operational staff are prepared appropriately; lead, manage and host regulatory inspections.

• Review and approve responses to inspection findings and provide guidance and support to ensure proper corrective and preventive measures are included. Ensure inspection responses are completed and returned to regulatory agencies, sponsors and other third parties in a timely manner.

• Analyze tracking and trending of issues related to regulatory inspections and provide feedback to management as well as the operational and study teams.

• Complete client RFI questionnaires relating to inspection management and provide guidance to junior staff in RFI responses.

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

• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process, including an expert understanding of ICH and GCP

• Excellent knowledge of the drug development process from the perspective of a CRO, including solid professional experience in Inspection Readiness, preparation and management of regulatory inspections

• Proven ability to lead, develop, mentor and coach diverse teams, preferably in a quality assurance setting

• Flexibility to travel internationally (primarily within EMEA) occasionally is a must

• Excellent interpersonal, analytical and managerial skills, a strong customer focus and a keen attention to detail

• Business fluency in English (C1 and above) is a must

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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