Quality Excellence Leader
The Quality Excellence Leader is a pivotal role that requires strategic vision and technical expertise to drive quality excellence across the organization.
About the Role
This position entails leading the Quality function, ensuring the implementation, maintenance, and effectiveness of ICH Q10-compliant Quality Management Systems. The incumbent will oversee permanent inspection readiness by planning, implementing, and controlling site Quality Systems, providing QA oversight for plant capital projects, and qualifying manufacturing and laboratory equipment, QA IT tools, utilities, and facilities.
This leader fosters a culture of partnership and inclusion across departments, driving excellence in compliance, supply, strategy, and cost. They hold ultimate responsibility for API batch release, ensuring all batches meet current EU and FDA GMP directives and relevant marketing authorizations.
Key Objectives:
* Assess product introductions and major capital projects for Quality and validation considerations, collaborating with site and global functions to ensure compliant, on-time projects and commercial supply of product to the network.
* Establish and maintain an effective Quality organization managing Quality Systems, Method Validation, Analytical Testing, Registration, and Batch Release.
* Lead the development of compliant, robust, and lean Quality Management Systems aligned with ICH Q1, Q7, Q10, and regulatory requirements.
* Recruit, train, and appraise Quality management staff, ensuring ongoing development and succession planning.
* Implement governance systems to monitor process performance and product quality, ensuring continued capability and suitability.
* Lead continuous improvement initiatives to enhance compliance, quality systems, and product lifecycle performance.
* Monitor and communicate new GMP compliance standards to the site.
* Act as the lead representative for the site during external GMP audits and regulatory inspections.
* Partner with site leadership to integrate Quality with other operational areas effectively.
* Ensure all API production complies with cGMP and applicable quality regulations.
* Make final decisions on non-routine batch dispositions.
* Liaise with Quality, supply organizations, and customers on significant product supply issues.
* Develop and manage the annual Quality department operating plan and budget.
* Represent the site in corporate and industry Quality forums.
* Serve as a role model to promote a strong quality and compliance culture across the site.
* Lead Safety Compliance within Quality and Laboratory functions, ensuring risk assessments, training, and safety measures are in place and effective.
Requirements
This role requires an individual with a strong background in pharmaceutical or veterinary manufacturing, including significant management roles. A recognized Lean Six Sigma Qualification (Yellow Belt, Green Belt, or Black Belt) is also essential. The ideal candidate will have comprehensive knowledge of GMP regulations and expectations governing facilities, equipment, and procedures for API manufacturing as per ICH Q7.
A proven track record of making quality and compliance decisions, including product release decisions, applying scientific and regulatory judgment, is necessary. Experience leading continuous improvement projects (e.g., RFT, Operational Excellence/Lean) and developing and maintaining Quality Systems in accordance with ICH Q10 principles is also required.
Desirable Skills:
* Strong leadership, communication, motivation, and people management skills.
* Ability to work effectively in cross-functional teams at site and strategic levels.
* Flexible, adaptable, and open to new ideas.
* Commitment to Zoetis Core Values and fostering a culture of GMP compliance and continuous improvement.
* Strong problem-solving abilities and good judgment.
* Excellent written and oral communication skills.
* Results-driven with a passion to win.
Location
This is a site-based position in Rathdrum, Ireland. The role requires fluent use of teleconferencing tools and Sharepoint technologies to share and manage information with Global Quality Centre Organization and other internal API manufacturing network.