Site Quality Leader

POSITION SUMMARY

The Site Quality Leader is responsible for leading the Quality function at the Rathdrum site. This role encompasses ownership of Quality Systems and Laboratory Control Systems, ensuring that ICH Q10-compliant Quality Management Systems are implemented, maintained, and operating effectively.

The Site Quality Leader drives permanent inspection readiness by overseeing the planning, implementation, and control of site Quality Systems and providing QA oversight for plant capital projects, including qualification of manufacturing and laboratory equipment, QA IT tools, utilities, and facilities.

As a member of the Site Leadership Team, this role fosters a culture of partnership and inclusion across departments, driving excellence in compliance, supply, strategy, and cost.

The Site Quality Leader holds ultimate responsibility for API batch release, ensuring all batches meet current EU and FDA GMP directives and relevant marketing authorizations.

POSITION RESPONSIBILITIES

Key objectives of this position include:

Assess product introductions and major capital projects for Quality and validation considerations. Collaborate with site and global functions to ensure compliant, on-time on-time projects (where applicable) and commercial suppl 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, Zoetis and regulatory requirements. Recruit, train, and appraise Quality management staff, ensuring ongoing development and succession planning is in place and is active. Implement governance systems to monitor process performance and product quality, assuring 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.

Investigate incidents and implement preventative actions as required.

Developing and managing the annual Operating Plan for department and Site Quality Annual Plan . Overseeing Site capital investment to drive quality and compliance Developing QA/QC budget and resources planning for the Site Lead Site Quality Management Review, Site Quality Council and Recall Committees Representing the site in corporate and industry Quality forums.

ORGANIZATIONAL RELATIONSHIPS

 Lead direct reports within the Quality team and collaborate broadly across the site including capital projects teams and site leadership.

 Work closely with the Site Lead, extended leadership, and Global Quality to achieve quality goals and strategic objectives.

EDUCATION AND EXPERIENCE

• Undergraduate degree in pharmaceutical, biological or chemical sciences.
• Relevant advanced degree preferred.
• Training & Experience at application of Change Execution Methodology
• Recognised Lean Six Sigma Qualification (Yellow Belt, Green Belt or Black Belt).
• 10 years’ experience, including significant management roles, in a pharmaceutical/veterinary manufacturing environment.
• Comprehensive knowledge of world-wide GMP regulations and expectations governing facilities, equipment and procedures for the manufacture and control of API’s as per ICHQ7.
• Proven track record of making quality and compliance decisions (including Product release decisions) applying sound scientific & regulatory judgment and who take a holistic approach understanding business impact of their decisions and drive towards permanent Inspection Readiness (PIR).
• Demonstrated experience of leading and driving results in continuous improvement projects (e.g. Right First Time (RFT), Operational Excellence/Lean Projects.
• In-depth knowledge of GMP validation standards and systems (process, cleaning, equipment, computer, water, analytical).
• Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.
• Familiarity with analytical testing methods, instruments and laboratory resource structures.
• Familiarity with API technology transfer and new product introductions.

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

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.

PHYSICAL POSITION REQUIREMENTS

This is a site-based position at Rathdrum, Ireland. This position will require fluent use of teleconferencing tools, as well as Sharepoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.

Legal statement as below

This job advert indicates the general nature and level of work expected.  It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.  Incumbent may be asked to perform other duties as required.  Additional position specific requirements/responsibilities are contained in approved training curricula. 

Visa status re must be eligible to work and live in Ireland as below

Colleague must be legally eligible to live and work in Ireland.

Summary of our Benefits

In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays,  a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.