Quality Assurance Leadership Opportunity
A Quality Associate Director is required to lead a team of 25 people in a Global GMP facility based in Cork. This role offers significant strategic level exposure and will be instrumental in upcoming projects for the site.
About the Role
This role provides quality and compliance expertise to ensure that all pharmaceutical products manufactured and distributed by the organization meet the highest standards of quality, safety, and regulatory compliance.
* Recruit, coach, and develop organizational talent to foster 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.
* Act as Pharmaceutical Head of Quality, applying and leveraging a comprehensive knowledge of pharmaceutical quality systems to ensure the highest quality products and compliance with GMP Guidance and regulatory requirements.
* Ensure efficient compliance with all applicable regulations through a robust quality system and communication with regulatory authorities.
* 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).
* Collaborate with the NPI team to ensure product designs, formulations, and processes comply with cGMP standards and regulatory expectations.
* Support the site QP and serve as a backup QP to ensure that pharmaceutical products are properly reviewed and released in compliance with regulatory standards.
Requirements
To be successful in this role, you will need:
* A Level 8 degree in a relevant field.
* 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).
* Experience as QP is preferable.
What We Offer
This role offers significant strategic level exposure and will be instrumental in upcoming projects for the site. The successful candidate will have the opportunity to make a real impact on the organization's success and growth.
Join our organization as a Quality Associate Director and take your career to the next level!