Quality Director

Job Description

A pharmaceutical manufacturing facility in North Dublin is looking for a Quality Director to join their Site Leadership Team.

This is a key leadership role which will have the Quality oversight for all Manufacturing, DP and product release activities across the site.

As a member of the SLT, you will be instrumental in strategic planning and the delivery of site goals. This role will promote operational excellence and cross functional working. In this role you will be the primary interface between Global Product Quality stakeholders and the site, ensuring effective communication on global functional requirements and site constraints. You will oversee the overall Quality function with a team of professionals across QC, QA and QP. In doing so you will be actively encouraging a risk-based Quality culture onsite.

Responsibilities:

• Ensure appropriate Quality standards are applied to the products and to the site's Manufacturing and Development Operations in accordance with regulatory requirements and group standards.
• Lead the Quality Function: Quality Assurance, Quality Control, Validation, Regulatory Affairs and Drug Product Test and Release.
• Build, develop, and mentor a high performing team, actively promoting cross functional teamwork.
• Ensure the development and efficient operation of the site's quality systems, particularly concerning Unplanned Events, Internal and External Audit, Change Control, Complaints, Documentation, Validation, Testing, and the Stability programme
• Develop & maintain relationships with regulatory authorities and lead the inspection process to ensure site conformity with regulatory authorities
• Contribute to the development of Global Quality policy and strategy, and to the installation of best practices worldwide, as part of the Global Quality functional team.

Requirements:

• BSc in a relevant degree. A PhD in a relevant field would be highly desirable.
• Proven experience managing large Quality groups in a GMP environment.
• Strong analytical and scientific mindset, bringing exceptional leadership and decision-making capability.
• 10+ years experience in a leadership role

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.