Quality and Regulatory Compliance Director - Ireland
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Responsible for evaluation, improvement and maintenance of programs to ensure compliance on products manufactured by company sites and third party contractors.
- 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 training 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.
- 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
- Our company 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.