Role Description
As the Pharmacovigilance (PV) Quality Assurance Team Lead within the Regulatory Affairs, Global Quality & Compliance (GQC) group, oversee the Quality Assurance (QA) PV program for Zoetis. Continuously develop and drive the strategy for quality and regulatory compliance within the program. Within this role, instill a philosophy of risk balance, consistency and efficiency within the Zoetis community, Global Pharmacovigilance, and other stakeholders of the company.
As a leader within the GQC group, provide quality assurance oversight to the global PV program. Be the point of contact for pharmacovigilance QA, ensuring alignment and open communication with US and European Pharmacovigilance teams and other stakeholders of the program. Lead the day-to-day GQC PV operational activities including the scheduling of GQC PV auditing activities (process audits, distributor and Zoetis Country Office audits). Be proficient in performing pharmacovigilance quality assurance audits and inspections of Veterinary Medicine Research & Development (VMRD) PV processes as well as those PV processes which reside outside the VMRD organization (e.g., country offices, distributors). Take a lead QA role in the management of CAPA and deviation activities for pharmacovigilance operations. Participate in government inspections of the pharmacovigilance program and others types of inspections as requested. Provide advice on regulatory and corporate compliance, as well as provide evaluations of current practices that may need improvements. Provide novel approaches to increasing effectiveness of both the GQC group and the quality and compliance of VMRD. Interact effectively with VMRD managers and their staff as an advisor on the interpretation of compliance aspects. Supervise GQC colleagues and contractors who participate in PV audits. Be responsible for meeting company driven deadlines for conducting performance evaluations, colleague development planning, and other required supervisory roles. Assist the GQC General Lead with budgetary planning and monitoring activities. Where appropriate, assist with staff recruitment and training. Participate in a variety of quality assurance-related activities including staff and project meetings, non-research study document reviews, and consultations with VMRD colleagues. Take a lead role in participating in VMRD meetings, specifically GQC PV meetings, projects and ad hoc committees for quality initiatives. Communicate (verbal and written) well with VMRD colleagues, management level individuals, and external parties (e.g., distributors, CROs, vendors). Ability to effectively represent the company or the GQC group in external-facing situations.
EDUCATIONAL BACKGROUND/EXPERIENCE
MINIMUM:
Bachelor’s Degree or equivalent in biology, animal science or other relevant science field.
DESIRABLE:
Master’s degree or equivalent in biology, animal science or other relevant science field.
WORKS EXPERIENCE/SKILLS
MINIMUM:
Demonstrated relevant auditing experience (minimum 5 years) in veterinary pharmacovigilance or related regulatory environment. Experience with deviation/CAPA processes and associated documentation. Experience in managing people. High level of competency using Microsoft Office suite (e.g., Word, Excel, Outlook). Establishment of excellent interpersonal relations; good communications; ability to negotiate, risk assess, and problem-solve. Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once. Ability to travel, if needed.
DESIRABLE:
10+ years working in a research quality assurance field supporting animal health trials. 5+ years in managing people. Experience in conducting pharmacovigilance audits and participating in regulatory inspections. Experience in working with pharmacovigilance databases. Proficiency in the understanding of current regulatory requirements regarding the quality of research for registration of animal products in major global markets. Proficiency in performing quality assurance audits and inspections of non-clinical and clinical veterinary product studies and reports (including protocols, data/data listings, statistics, master study files, final study reports, clinical investigator study sites and in-phase inspections) and of facilities, CROs and processes that support those studies.
Full time
#J-18808-Ljbffr