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- Tasks: Lead GCP compliance and quality assurance across clinical development in EMEA.
- Company: Join a global pharmaceutical organisation dedicated to innovative healthcare solutions.
- Benefits: Enjoy flexible working options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety while collaborating with diverse teams.
- Qualifications: Requires a degree in life sciences and 7-10 years of relevant experience.
- Other info: Willingness to travel internationally (25-30%) is essential.
The predicted salary is between 43200 - 72000 £ per year.
Cpl Life Sciences is partnered with a global pharmaceutical organisation to source for an Associate Director, EMEA Clinical Quality Assurance (CQA). The candidate will lead as the GCP Subject Matter Expert (SME) on the development team, ensuring regulatory and quality compliance with GCP standards and other relevant regulatory requirements. This role involves both internal and external collaboration to uphold compliance across systems, processes, and outcomes in alignment with international and national standards.
Key Responsibilities:
- Act as GCP and EMEA regulation SME.
- Contribute to and support a risk-based, scientifically-driven quality system for supporting GCP compliance.
- Design, develop and implement a strategic audit plan, conduct audits of investigator sites, vendors, and internal systems, ensuring compliance with SOPs and regulations.
- Lead the assessment and approval of vendors for potential use, offering guidance and oversight to ensure alignment with company quality and compliance standards.
- Collaborate cross-functionally to address and mitigate GCP quality and compliance issues.
- Ensure adherence to the ICH E6 Guideline for Good Clinical Practice and mentor staff to enhance quality and auditing skills.
- Manage quality documentation in Veeva QMS and Vault.
- Represent the company in regulatory inspections.
Requirements:
- BS in Biology, Chemistry, or related life sciences degree with at least 7-10 years of experience, or advanced degree (MS, PhD, MBA) preferred with additional equivalent experience.
- Experience with managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation.
- Biologics experience preferred.
- Experience with SOP development relevant to clinical, regulatory and medical processes.
- Proficiency with GCP auditing, including external investigator sites, CROs, supporting laboratories, and responsibility for audit reporting, reviewing and tracking CAPAs.
- Proficient in GCP and EU clinical regulations, and risk-based quality systems aligned with ICH E6.
- Significant GCP audit experience, including audit reporting and CAPA tracking.
- Extensive knowledge of Phases I-IV (especially Phase III), with preference for regulatory approval, NDAs, and MAAs experience.
- Highly organized, collaborative, and adaptable, with an attention to detail and accuracy.
- Demonstrating values of respect, passion, integrity, collaboration, and accountability.
- Able to travel domestically and internationally (25-30%).
Associate Director EMEA of CQA employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director EMEA of CQA
✨Tip Number 1
Network with professionals in the clinical quality assurance field, especially those who have experience with GCP and EMEA regulations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the ICH E6 Guideline for Good Clinical Practice and other relevant regulations. Being well-versed in these standards will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with regulatory inspections and how you managed them. Highlight specific examples where you successfully collaborated with regulators and internal teams to ensure compliance, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Showcase your leadership abilities by discussing any mentoring or training experiences you've had. Emphasising your capacity to guide others in quality assurance practices will align well with the responsibilities of the Associate Director role.
We think you need these skills to ace Associate Director EMEA of CQA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in GCP compliance, auditing, and regulatory inspections. Use specific examples that demonstrate your expertise in the areas mentioned in the job description.
Craft a Compelling Cover Message: In your cover message, express your passion for quality assurance in clinical settings. Mention how your values align with those of the company, and provide a brief overview of your relevant experience and skills.
Highlight Key Achievements: When detailing your work history, focus on key achievements related to GCP and EMEA regulations. Quantify your successes where possible, such as the number of audits conducted or improvements made in compliance processes.
Showcase Collaboration Skills: Since the role involves cross-functional collaboration, include examples of how you've successfully worked with different teams or stakeholders to address compliance issues or improve quality systems.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your GCP Expertise
As the role requires you to be a GCP Subject Matter Expert, be prepared to discuss your extensive knowledge of Good Clinical Practice. Highlight specific examples from your past experiences where you ensured compliance and how you handled challenges related to GCP standards.
✨Demonstrate Regulatory Insight
Familiarise yourself with EMEA regulations and ICH E6 guidelines. During the interview, articulate how your understanding of these regulations has influenced your previous work, especially in managing regulatory inspections and preparing for them.
✨Prepare for Cross-Functional Collaboration
This position involves collaboration across various teams. Be ready to share instances where you successfully worked with different departments to address GCP quality issues. Emphasise your communication skills and ability to lead cross-functional initiatives.
✨Discuss Your Audit Experience
Given the importance of auditing in this role, prepare to talk about your audit experience in detail. Discuss the types of audits you've conducted, your approach to developing audit plans, and how you tracked CAPAs to ensure compliance.
