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- Tasks: Lead quality assurance initiatives and ensure compliance in clinical trials.
- Company: Join a global CRO dedicated to innovative solutions for persistent diseases.
- Benefits: Enjoy remote work flexibility and a supportive, inclusive culture.
- Why this job: Make a real impact on healthcare while working with passionate experts.
- Qualifications: M.S. or equivalent with 5+ years in GCP; strong regulatory knowledge required.
- Other info: Opportunity for travel and collaboration with international teams.
The predicted salary is between 43200 - 72000 £ per year.
Join Worldwide Clinical Trials as an Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote.
About Us: We are a global, midsize CRO committed to innovation and excellence in the pursuit of cures for persistent diseases. Our team of over 3,500 experts is dedicated to changing the way the world experiences CROs by taking pioneering and creative approaches.
Why Join Us: We value diversity, inclusion, and collaboration, fostering an environment where everyone can thrive and do their best work. Our culture emphasizes quality, passion, and purpose in improving lives.
Role Overview: The Quality Assurance department at Worldwide sets high standards for quality, exceeding sponsor, participant, and regulatory expectations. We empower staff to deliver high-quality products through training and a supportive environment.
Responsibilities:
- Champion the adoption of the Quality Management System (QMS).
- Provide consultancy and oversight for Quality Issues (QIs) and CAPA Plans.
- Maintain up-to-date electronic documentation for QI and CAPA activities.
- Act as GCP SME, offering consultancy to project teams within the assigned Therapeutic Area (TA).
- Perform TA and study data review and trending activities.
- Support risk assessment processes in collaboration with Risk-Based Quality Management.
- Provide support for Clinical Investigator Site inspections and audits.
- Review QMD deviations and provide GCP consultancy within the SME area.
- Review Quality Management Documents (QMDs) during revisions or regular cycles.
- Manage QA relationships with Sponsor QA counterparts, including quality agreements and metrics.
- Manage the operational relationship between QA and TA/operational leadership.
- Assist with Sponsor audits and regulatory inspections as needed.
Qualifications and Experience:
- M.S. or equivalent in a scientific or health-related field with 5+ years of relevant GCP, GcLP, GLP, GVP, and GPP experience.
- Bachelor’s degree or equivalent in biological, physical, health, pharmacy, or related sciences with 7+ years of relevant experience.
- Broad understanding of quality and regulatory compliance related to GxP activities, especially GCP.
- Excellent knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Directives, and UK Statutory Instruments relevant to GCP.
- Understanding of drug development processes.
- Experience supporting Regulatory Inspections is a plus.
- Willingness to travel domestically and internationally (up to 15%).
We are committed to creating an inclusive environment and are proud to be an equal opportunity employer.
Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote employer: Worldwide Clinical Trials
Contact Detail:
Worldwide Clinical Trials Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote
✨Tip Number 1
Familiarise yourself with the latest ICH Guidelines and FDA regulations, as these are crucial for the role. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in Quality Management Systems. Engaging in discussions or attending relevant webinars can provide insights that may set you apart during the interview process.
✨Tip Number 3
Prepare to discuss specific examples of how you've championed quality initiatives in previous roles. Highlighting your hands-on experience with CAPA plans and QIs will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Research Worldwide Clinical Trials' recent projects and their approach to quality assurance. Tailoring your conversation to reflect their values and demonstrating how your experience aligns with their mission can make a strong impression.
We think you need these skills to ace Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and regulatory compliance. Emphasise your knowledge of GCP, GcLP, GLP, and other related areas that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the role. Mention specific experiences that demonstrate your ability to champion Quality Management Systems and support regulatory inspections.
Highlight Relevant Qualifications: Clearly outline your educational background and any certifications that are pertinent to the role. Make sure to mention your M.S. or equivalent degree and any additional qualifications that relate to the therapeutic area.
Showcase Soft Skills: In your application, highlight soft skills such as collaboration, communication, and problem-solving. These are crucial for working effectively within a team and managing relationships with sponsors and operational leadership.
How to prepare for a job interview at Worldwide Clinical Trials
✨Understand the Quality Management System (QMS)
Familiarise yourself with the principles and practices of Quality Management Systems, especially as they relate to GCP. Be prepared to discuss how you have championed QMS in your previous roles and how you can apply that experience at Worldwide Clinical Trials.
✨Showcase Your Regulatory Knowledge
Highlight your understanding of ICH Guidelines, FDA regulations, and European Directives. Be ready to provide examples of how you've navigated regulatory compliance in past projects, as this will demonstrate your expertise in the field.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations, such as handling Quality Issues or CAPA Plans. Think of specific instances where you successfully managed similar challenges and be ready to share those stories.
✨Emphasise Collaboration and Communication Skills
Since the role involves managing relationships with various stakeholders, be sure to convey your ability to work collaboratively. Share examples of how you've effectively communicated with project teams and sponsors to ensure quality standards are met.
