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 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, Zoetis, 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.Additional responsibilities include investigating incidents, developing and managing the annual Operating Plan, overseeing capital investments, and representing the site in external 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 GMP regulations and expectations governing facilities, equipment, and procedures for API manufacturing as per ICH Q7.Proven track record of making quality and compliance decisions, including Product release decisions, applying scientific & regulatory judgment.Experience leading continuous improvement projects (e.g., RFT, Operational Excellence/Lean).In-depth knowledge of GMP validation standards and systems.Experience developing and maintaining Quality Systems in accordance with ICH Q10 principles.Familiarity with analytical testing methods and laboratory resources.Experience 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.
The role requires fluent use of teleconferencing tools and Sharepoint technologies to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.
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