Job Overview
A Quality Associate Director is required for a Global GMP facility based in Cork. This exciting opportunity provides a QA leader the chance to join a company at a time of growth with the view to becoming a global SME for the Pharmaceutical arm of the business.
Main Responsibilities
* Recruit, coach and develop organizational talent, fostering a diverse workplace that enables all participants to contribute to their full potential.
* Lead the Pharmaceutical Quality team, ensuring team members have the necessary training, skills and knowledge to effectively meet the quality requirements as detailed in regulatory standards, and drive process optimization initiatives.
* Act as Pharmaceutical Head of Quality, applying and leveraging a comprehensive knowledge of pharmaceutical quality systems that ensure the highest quality products and compliance with GMP Guidance and regulatory requirements.
* Evaluate and analyze the effectiveness of the quality system and recommend changes as needed.
* Ensure efficient compliance with all applicable regulations through a robust quality system and communication with regulatory authorities.
* Prepare for both internal and external audits and regulatory inspections, leading audit teams and collaborating with cross-functional teams to address and resolve any observations or deficiencies.
* Lead complex analysis of data and decisions regarding quality-related crises in the area of responsibility.
* Foster an entrepreneurial environment where individuals identify and bring forward process, policy and system improvements to the Pharmaceutical Quality System (PQS).
Requirements
* A relevant Level 8 degree.
* 10+ years of experience in pharmaceutical/biotech manufacturing.
* 5+ years in a leadership role.
* A strong understanding of cGMP, ICH guidelines, EU GMP Annexes, and FDA/HPRA expectations.
* Experience with regulatory inspections (e.g., HPRA, FDA).