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- Tasks: Lead R&D Quality activities and ensure compliance with global quality standards.
- Company: Join a multinational biotechnology company making waves in the life sciences sector.
- Benefits: Enjoy remote work flexibility and a competitive salary package.
- Why this job: Be part of a dynamic team driving quality improvements and regulatory readiness.
- Qualifications: Expertise in GCP, FDA, EMA regulations; 4-8 years of relevant experience required.
- Other info: Opportunity to collaborate globally and enhance operational efficiency.
The predicted salary is between 43200 - 72000 £ per year.
Associate Director, Quality Systems
Location: Remote, Europe
Salary: Negotiable
Type: Permanent
Cpl Life Sciences have partnered with a multinational biotechnology company to recruit for someone to oversee and manage R&D Quality activities, ensuring global quality policies, procedures, and regulatory requirements are consistently applied at regional and affiliate levels. Support affiliates in implementing fit-for-purpose QMS, driving harmonization across global, regional, and local operations.
Key Responsibilities:
- Implement Risk-Based Quality Management and Quality by Design principles.
- Act as a liaison between global HQ and local affiliates, providing guidance on QMS development and compliance.
- Identify process improvements and align quality systems with global and local regulations.
- Provide training, tools, and resources to enhance operational efficiency and compliance.
- Monitor and analyze quality metrics, identify risks, and drive data-driven improvements.
- Collaborate with stakeholders to prioritize quality efforts and ensure regulatory readiness.
- Support affiliates in inspection and audit preparedness.
Essential Experience:
- Expert knowledge of GCP, FDA, EMA, MHRA, and ICH regulations.
- Bachelor’s (8+ yrs), Master’s (6+ yrs), or PhD/MD/PharmD (4+ yrs) in R&D quality assurance.
- Proven leadership, process improvement, and strategic problem-solving skills.
- Strong project management, mentoring, and compliance expertise.
If you are interested and want to know more about this role, reach out to me at
#J-18808-Ljbffr
Associate Director, Quality Systems employer: Cpl Healthcare
Contact Detail:
Cpl Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Quality Systems
✨Tip Number 1
Familiarize yourself with the latest GCP, FDA, EMA, MHRA, and ICH regulations. Being well-versed in these guidelines will not only boost your confidence during interviews but also demonstrate your commitment to quality systems.
✨Tip Number 2
Highlight your experience in implementing Risk-Based Quality Management and Quality by Design principles. Be prepared to discuss specific examples where you've successfully applied these concepts in previous roles.
✨Tip Number 3
Showcase your leadership and mentoring skills. Think of instances where you've guided teams or individuals in quality assurance processes, as this aligns perfectly with the responsibilities of the Associate Director role.
✨Tip Number 4
Network with professionals in the biotechnology field, especially those involved in R&D quality assurance. Engaging with industry peers can provide valuable insights and potentially lead to referrals for the position.
We think you need these skills to ace Associate Director, Quality Systems
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description. Understand the key responsibilities and essential experience required for the Associate Director, Quality Systems position. Tailor your application to highlight how your background aligns with these requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasize your expertise in GCP, FDA, EMA, MHRA, and ICH regulations. Provide specific examples of your leadership and process improvement experiences that demonstrate your ability to manage R&D Quality activities effectively.
Showcase Your Skills: Make sure to showcase your project management, mentoring, and compliance skills. Use quantifiable achievements to illustrate your strategic problem-solving capabilities and how you have driven data-driven improvements in previous roles.
Craft a Compelling Cover Letter: Write a personalized cover letter that connects your professional journey to the role. Discuss your passion for quality systems and how you can contribute to the company's mission of ensuring global quality policies and regulatory compliance.
How to prepare for a job interview at Cpl Healthcare
✨Showcase Your Regulatory Knowledge
Make sure to highlight your expertise in GCP, FDA, EMA, MHRA, and ICH regulations during the interview. Prepare specific examples of how you've applied these regulations in past roles to demonstrate your deep understanding.
✨Emphasize Leadership and Collaboration
Since the role involves acting as a liaison between global HQ and local affiliates, be ready to discuss your leadership experiences. Share instances where you successfully led teams or collaborated with stakeholders to drive quality improvements.
✨Discuss Process Improvements
Prepare to talk about specific process improvements you've implemented in previous positions. Focus on how these changes aligned with global and local regulations and enhanced operational efficiency.
✨Be Data-Driven
The role requires monitoring and analyzing quality metrics. Be prepared to discuss how you've used data to identify risks and drive improvements in quality systems. Bring examples of metrics you've tracked and the outcomes of your initiatives.
