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
daniel.bailey@cpl.com
#J-18808-Ljbffr
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
daniel.bailey@cpl.com
#J-18808-Ljbffr
