Position Summary
Secondment opportunity for 12 months
The Quality Lead is responsible for leading and coordinating quality activities across the organization, ensuring compliance with internal, external, and Regulatory requirements.
This role encompasses oversight of Quality Management Systems (QMS), supplier quality, training, documentation control, and project initiatives.
The Quality Lead drives continuous improvement, regulatory compliance, and a strong quality culture, working closely with cross-functional teams to achieve site objectives.
The Quality Lead will be responsible for Management of defined Quality Systems under their remit.
Responsibilities
Assume a lead role in the oversight, maintenance, and continuous improvement of site QMS to ensure ICH Q10 and cGMP compliance.
Lead Quality teams to ensure systems remain in a compliant and audit-ready state.
Lead change control, issue management, non-conformance events, and CAPA programs.
Prepare for and participate in internal, external, and regulatory audits, including vendor audits.
Monitor, report, and present quality metrics and trends at site and global levels.
Lead supplier quality management, including vendor assessments, auditing, qualification, and quality agreements.
Ensure effective vendor change notification management and maintain strong supplier relationships.
Lead training and documentation control activities to ensure compliance and audit readiness.
Oversee documentation control and archival processes for the site.
Develop and deliver training on quality topics and metrics.
Lead quality projects to optimize systems, processes, and methods, introducing lean measures and eliminating bottlenecks.
Support facility modification and expansion projects as the quality lead.
Participate in OpEX initiatives and value stream mapping to drive efficiency.
Interface with Engineering, Laboratories, Operations, Warehouse, GMT, and Supply Chain to ensure quality objectives are met.
Execute an engaged Quality relationship across the site, fostering a strong quality culture.
Lead and coordinate Site Quality Council meetings.
Provide routine updates to senior leadership on compliance and quality issues.
Back-up for other Quality Leads as required.
Requirements
BSc or MSc in a relevant discipline (e.g., biochemistry, chemistry, process engineering).
At least 5-7 years of relevant experience in a Pharma/BioPharma manufacturing environment.
Strong experience in biotech/pharmaceutical QA, with deep knowledge of cGMP, EU/FDA regulations, QbD, and Risk Management.
Demonstrated success in leading QMS, supplier management, and compliance.
Proven track record with LEAN and Six Sigma principles; skilled in process mapping.
Ability to lead, motivate, and develop a team of QA professionals.
Experience managing multiple projects and prioritizing tasks.
Excellent interpersonal and communication skills, meticulous attention to detail.
Solution-oriented, capable of independently driving improvement initiatives.
Self-motivation and ability to work collaboratively with cross-functional teams.
Physical Position Requirements
Role will be based on site at Zoetis Tullamore Site
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals.
As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock.
We know our people drive our success.
Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support.
We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
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