Associate Director, Quality Systems

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 [email protected]