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For Companies At a Glance
- Tasks: Lead global QA strategy and ensure compliance in clinical services.
- Company: Fortrea, a leader in clinical research with a focus on quality and regulatory compliance.
- Benefits: Remote work options, competitive salary, and opportunities for professional growth.
- Why this job: Drive continuous improvement and make a significant impact in global clinical research.
- Qualifications: Advanced degree preferred; 15+ years in clinical QA and leadership experience required.
- Other info: Collaborative environment with a strong culture of quality and operational excellence.
The predicted salary is between 72000 - 108000 £ per year.
Global Head Clinical Services Regulatory Compliance & QA
4 days ago Be among the first 25 applicants
Job Overview
This leader will report into the Chief Quality, Regulatory, and Sustainability Officer along with the leaders of the Clinical Pharmacology Services QA team, the Head of the Global Quality Office, and the ESG Leader. Collectively, this leadership team is responsible for creating and driving the Quality System at Fortrea. This leader will bring deep expertise in the conduct of global clinical research, a strategic mindset, and collaborative leadership style to drive continuous improvement and operational excellence.
Remote Work locations:
East Coast, US
UK
Western EU
Job Overview
This leader will report into the Chief Quality, Regulatory, and Sustainability Officer along with the leaders of the Clinical Pharmacology Services QA team, the Head of the Global Quality Office, and the ESG Leader. Collectively, this leadership team is responsible for creating and driving the Quality System at Fortrea. This leader will bring deep expertise in the conduct of global clinical research, a strategic mindset, and collaborative leadership style to drive continuous improvement and operational excellence.
The Global Head of the Clinical Services Regulatory Compliance & Quality Assurance (RCQA) unit is responsible to create the strategy, budgetary requirements, and alignment of resources to deliver compliance and quality solutions across Fortrea Clinical Services. This leader will serve as the business partner to the President of Fortrea Clinical Services to deliver a strong, overarching culture of quality and regulatory compliance to all applicable laws, standards, certifications, and contractual agreements.
Summary Of Responsibilities
Fortrea Quality System
- Define and execute the Quality System that regulates Fortrea Clinical Services
- Develop and implement a global QA strategy aligned with corporate goals and regulatory expectations
- Ensure adherence to global regulations through the creation and completion of a strong quality risk framework of annual audits. These annual audit plans will confirm compliance of the Fortrea processes, systems, and projects within Fortrea Clinical Services
- Ensure robust CAPA, deviation, audit, and inspection readiness programs are in place
- Represent Regulatory Compliance & Quality Assurance on all potential mergers/acquisitions, along with the subsequent integrations of the target entity.
Collaboration
- Serve as a key member of the extended leadership team, contributing to overall business strategy and risk management
- Partner with the business leaders to implement and oversee the quality system, ensuring a collaborative approach to driving a strong culture of quality. Work closely with leadership, clinical operations, legal, corporate compliance, and training to ensure alignment on quality objectives
- Develop proactive measures to mitigate quality-related risks and maintain compliance with global regulatory bodies with the Fortrea Clinical Services business leaders
Development and Continuous Improvement
- Identify and implement continuous improvement initiatives to enhance operational and QA efficiency and reduce risks
- Build, lead, and mentor a high-performing global QA team
- Oversee the QA team to serve as the primary contact in regulatory inspections and audits of Fortrea
Metrics, Measurements and Reporting
- Establish Key Quality Metrics/Indicators, analyze trends, and report findings to executive leadership for informed decision-making
- Represent Regulatory Compliance & Quality Assurance QMS data, actions, and risks in senior leadership meetings such as the Executive Committee, and in stage-up to the Board of Directors
- Direct the enhancements and functionality improvements of the Fortrea QMS Quality Vault for Clinical QA
Qualifications (Minimum Required)
- Advanced degree in Life Sciences preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
- Proven leadership experience in a global QA role
- In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory standards
- Experience directing global audits and regulatory inspections
- Experience leading global teams
Experience (Minimum Required)
- Minimum 15 years of experience in clinical QA within a CRO, pharmaceutical, or biotech environment
- 20 years of experience in the clinical research industry
Preferred Qualifications Include
- Experience with digital QA systems and eQMS platforms
- Familiarity with decentralized trials and digital health technologies
Learn more about our EEO & Accommodations request here.
Seniority level
- Executive
Employment type
- Full-time
Job function
- Legal
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Global Head Clinical Services Regulatory Compliance & QA employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Head Clinical Services Regulatory Compliance & QA
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or through professional groups. A personal connection can often get your foot in the door faster than a CV.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your experience in regulatory compliance and QA. This will help you stand out as a candidate who truly gets them.
✨Tip Number 3
Practice your pitch! Be ready to explain how your background in global clinical research and quality assurance makes you the perfect fit for the role. Confidence is key, so rehearse until it feels natural.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Global Head Clinical Services Regulatory Compliance & QA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Global Head Clinical Services Regulatory Compliance & QA role. Highlight your leadership experience and knowledge of global QA standards to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share your strategic mindset and collaborative leadership style, and don’t forget to mention your passion for quality and compliance.
Showcase Relevant Experience: When filling out your application, be sure to showcase your extensive experience in clinical QA and any relevant achievements. We love seeing how you've driven continuous improvement and operational excellence in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at Fortrea!
How to prepare for a job interview at Fortrea
✨Know Your Regulations
Make sure you brush up on ICH-GCP, FDA, and EMA regulations. Being able to discuss these in detail will show your deep expertise in regulatory compliance, which is crucial for the role.
✨Showcase Your Leadership Style
Prepare examples that highlight your collaborative leadership style. Think of situations where you successfully led a team through challenges or implemented quality improvements, as this aligns with the job's focus on driving a culture of quality.
✨Understand the Quality System
Familiarise yourself with Fortrea's Quality System and be ready to discuss how you would define and execute it. This shows that you're not just a fit for the role but also proactive about contributing to their goals.
✨Prepare for Strategic Discussions
Since this role involves partnering with business leaders, think about how you can contribute to overall business strategy and risk management. Be prepared to discuss your strategic mindset and how you've driven continuous improvement in past roles.
