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Pharmacovigilance Quality Assurance Lead
Apply locations Zaventem | Full time | Posted yesterday | Job Requisition ID: JR00018266
Zoetis Zaventem is seeking a Pharmacovigilance (PV) Quality Assurance Team Lead.
As part of the Regulatory Affairs, Global Quality & Compliance (GQC) group, you will oversee the Quality Assurance (QA) PV program for Zoetis. Your role involves developing and implementing strategies for quality and regulatory compliance, fostering a culture of risk management, consistency, and efficiency across the Zoetis community, Global Pharmacovigilance, and other stakeholders.
Key Responsibilities
1. Provide quality assurance oversight to the global PV program as a leader within the GQC group.
2. Serve as the main contact for pharmacovigilance QA, ensuring effective communication and alignment with US and European Pharmacovigilance teams and other stakeholders.
3. Manage daily GQC PV operational activities, including scheduling audits (process, distributor, and country office audits).
4. Perform pharmacovigilance quality assurance audits and inspections of Veterinary Medicine Research & Development (VMRD) PV processes and external PV processes (e.g., country offices, distributors).
5. Lead CAPA and deviation management activities for pharmacovigilance operations.
6. Participate in government inspections and other relevant audits of the pharmacovigilance program.
7. Advise on regulatory and corporate compliance; evaluate current practices and recommend improvements; introduce innovative approaches to enhance group effectiveness and compliance.
8. Supervise GQC colleagues and contractors involved in PV audits, ensuring timely performance evaluations and staff development.
9. Assist in budget planning and monitoring for the GQC group.
10. Support staff recruitment and training initiatives.
11. Engage in quality assurance activities, including meetings, document reviews, and consultations.
12. Lead participation in VMRD meetings, projects, and quality committees.
13. Communicate effectively with internal teams and external partners, representing the company professionally in external-facing situations.
Educational Background & Experience
Minimum: Bachelor's Degree in biology, animal science, or a related field.
Desirable: Master’s degree or equivalent in a relevant science field.
Work Experience & Skills
Minimum:
* At least 5 years of relevant auditing experience in veterinary pharmacovigilance or a related regulatory environment.
* Experience with deviation and CAPA processes.
* Management experience.
* Proficiency in Microsoft Office tools.
* Strong interpersonal, communication, negotiation, risk assessment, and problem-solving skills.
* Ability to work independently and handle multiple tasks, with flexibility and travel as needed.
Desirable:
* Over 10 years in research quality assurance supporting animal health trials.
* Over 5 years of management experience.
* Experience with pharmacovigilance audits and regulatory inspections.
* Experience with pharmacovigilance databases.
* Knowledge of regulatory requirements for animal product registration globally.
* Skilled in audits of non-clinical and clinical veterinary studies and related facilities.
About Us
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 leader in animal health, we develop vaccines, medicines, diagnostics, and technologies for pets and livestock. We value our people and foster a culture centered on our Core Beliefs, focusing on career growth, connection, and support. We offer comprehensive benefits supporting health, financial wellness, family, and lifestyle.
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