Associate Director, Quality Systems
Remote, Europe
Negotiable salary
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