A Quality Associate Director is required for a Global GMP facility based in Cork.
This is an exciting opportunity for a QA leader to join at a time of growth with the view to becoming a global SME for the Pharmaceutical arm of the business. This role reports to the sites Quality Director and will oversee a function of 25 people.
This role offers significant strategic level exposure and will be instrumental in upcoming projects for the site.
This role will provide 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.
Key Responsibilities
- Recruit, coach, and develop organizational talent. 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, and drive process optimization initiatives. Provide direction and guidance to the wider team, fostering a culture of excellence, collaboration, and continuous improvement.
- Act as Pharmaceutical Head of Quality. Applies and leverages a comprehensive knowledge of pharmaceutical quality systems that ensure the highest quality products and compliance with GMP Guidance and regulatory requirements. Review 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. Sets best practices and influences compliance with policies and procedures
- Ensure that all necessary preparations are made for both internal and external audits and regulatory inspections. Lead audit teams, collaborate with cross-functional teams to address and resolve any observations or deficiencies, ensuring continuous compliance with applicable regulations and quality standards. Responsible for the leadership of the Quality Operations team supporting chemistry based products.
- Leads complex analysis of data and decisions regarding quality-related crises in the their 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.
- This role will support the site QP and will ideally serve as a backup QP to ensure that pharmaceutical products are properly reviewed, and their release is compliant with regulatory standards.
Education & Experience
- Level 8 in a relevant degree
- 10+ years of experience in pharmaceutical/biotech manufacturing
- 5+ years in a leadership role.
- Strong understanding of cGMP, ICH guidelines, EU GMP Annexes, and FDA/HPRA expectations.
- Experience with regulatory inspections (e.g., HPRA, FDA).
- Experience as QP preferable.
