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- Tasks: Lead quality assurance efforts 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 relevant to GCP. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance in clinical trials.
✨Tip Number 2
Network with professionals in the CRO industry, especially those who have experience in Quality Assurance roles. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've championed quality management systems or handled quality issues in past roles. Real-life scenarios can showcase your expertise and problem-solving skills effectively.
✨Tip Number 4
Stay updated on current trends and challenges in the therapeutic areas relevant to the position. This will allow you to speak knowledgeably about the field and show your passion for improving lives through quality assurance.
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 GCP, GLP, and other quality assurance areas mentioned in the job description. Use specific examples that demonstrate your expertise in Quality Management Systems and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also reflects your passion for improving lives through quality assurance in clinical trials. Mention how your values align with Worldwide Clinical Trials' commitment to diversity and collaboration.
Highlight Relevant Experience: In your application, emphasise your experience with Quality Issues (QIs) and CAPA Plans. Provide concrete examples of how you've championed quality management systems or supported regulatory inspections in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at Worldwide Clinical Trials
✨Understand the Quality Management System (QMS)
Familiarise yourself with the Quality Management System that the company uses. Be prepared to discuss how you have championed QMS in your previous roles and how you can contribute to its adoption at Worldwide Clinical Trials.
✨Showcase Your GCP Expertise
As a GCP Subject Matter Expert, it's crucial to demonstrate your knowledge of Good Clinical Practice. Prepare examples of how you've provided consultancy on GCP issues in past projects, and be ready to discuss specific challenges you've faced.
✨Highlight Your Experience with Regulatory Inspections
If you have experience supporting regulatory inspections, make sure to highlight this during the interview. Discuss any specific instances where you played a key role in preparing for or managing inspections, as this will show your capability in handling high-pressure situations.
✨Emphasise Collaboration and Communication Skills
Given the emphasis on collaboration within the role, be prepared to share examples of how you've successfully worked with cross-functional teams. Highlight your ability to manage relationships with sponsors and operational leadership, as this is vital for the position.
