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Quality and Regulatory Compliance Director Dublin Ireland,  


Posted on : 17 January 2017

Project Description

Role Description Responsible for evaluation, improvement and maintenance of programs to ensure compliance on products manufactured by Zoetis sites and third party contractors. Responsibilities: The Compliance Director is responsible for : Compile product and process quality risks identified in Operations from Internal audits, Regulatory audits, EHS assessment, Risk dashboard, Balance score cards results and other metrics and identify potential gaps Develop a compliance plan with sites to ensure compliance with the ever changing regulatory environment Drive the overall compliance plan, follow actions put in place, and communicate update internally Work with sites to ensure a culture of compliance across GMS Lead a cross functional team to evaluate new risks being identified on a quarterly basis to come up with a mitigation plan Monitor risk mitigation progress of the Product/process related risks and escalate any concerns in term of prioritization or mitigation to appropriate governance boards Enable the consistent application of corrective actions across the network, ensure globalization as needed and enable effectiveness checks (verification of "in place" and "in use" as well as "effective") Design, implement and monitor performance metrics; perform periodic review and report system performance Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards and improves systems based on this knowledge Work with sites to ensure inspection readiness Exposure to Regulatory inspections including interactions with Regulatory Agency representatives and expert advice on responses to Regulatory Agency observations Define and roll out GMP trainings based on risks identified EDUCATION AND EXPERIENCE Indicate the formal education, certification or license required and/or preferred. Include the minimum number of years of relevant experience required for the position. S. with 15 years' experience, OR equivalent, in biological or pharmaceutical sciences, engineering, or related discipline. Minimum of 10 years PROGRESSIVE experience in the quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human pharmaceuticals or biologicals. A minimum of 5 years' experience in a compliance role TECHNICAL SKILLS and COMPETENCIES REQUIRED Indicate the technical skills required and/or preferred, as applicable. Include skills and knowledge essential to perform the position. Ability to develop and adhere to self-directed standard work. Minimum of 5 years supervisory/leadership experience, with project management experience. Demonstrated skills organizing and tracking data and documents. Demonstrated written communication skills, as well as experience with presenting to leadership teams. Demonstrated ability to organize and analyze complex data sets to help teams address issues impacting the sites ability to meet supply requirements be they quality, quantity or cost. Experience in managing situations to address issues with motivation, competency, or performance at the organizational level. Demonstrated ability to work with internal and external colleagues. Languages: English- fluent. Any other language is an asset Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant. Our name, Zoetis (zM-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning "pertaining to life." It signals our company's dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend.

Locations

Dublin Republic of Ireland

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