Pharmacovigilance Quality Assurance Lead

Zoetis Inc.; Kalamazoo (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking company as the Pharmacovigilance Quality Assurance Team Lead, where you'll oversee and enhance the quality assurance program in a dynamic regulatory environment. This role involves leading audits, managing teams, and ensuring compliance with international standards. You'll collaborate with global stakeholders, innovate quality initiatives, and play a crucial role in maintaining the integrity of pharmacovigilance processes. If you're passionate about animal health and quality assurance, this is an exciting opportunity to make a significant impact in a reputable organization.

Qualifications

• 5+ years of auditing experience in veterinary pharmacovigilance.
• Experience with deviation/CAPA processes and managing teams.

Responsibilities

• Oversee the Quality Assurance PV program and lead GQC PV operational activities.
• Provide quality assurance oversight and manage CAPA and deviation activities.

Skills

Auditing Experience

Deviation/CAPA Processes

Microsoft Office Suite

Interpersonal Skills

Communication Skills

Risk Assessment

Problem-Solving Skills

Team Management

Education

Bachelor's Degree in Biology or Animal Science

Master's Degree in Biology or Animal Science

Tools

Pharmacovigilance Databases

Microsoft Office (Word, Excel, Outlook)

Job description

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. Lead the day-to-day GQC PV operational activities, including scheduling of GQC PV audits (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 outside VMRD (e.g., country offices, distributors). Take a lead QA role in managing CAPA and deviation activities for pharmacovigilance operations. Participate in government inspections and other audits as requested. Provide advice on regulatory and corporate compliance, and evaluate current practices for improvements. Innovate approaches to enhance the effectiveness of GQC and VMRD quality and compliance. Interact effectively with VMRD managers and staff as an advisor on compliance interpretation. Supervise GQC colleagues and contractors involved in PV audits, ensuring timely performance evaluations and development planning. Assist the GQC Global Lead with budget planning and staff recruitment and training where appropriate. Participate in quality assurance activities, including staff meetings, document reviews, and consultations. Take a lead role in VMRD meetings, projects, and ad hoc committees for quality initiatives. Communicate effectively with internal and external parties, representing the company or GQC group professionally.

EDUCATIONAL BACKGROUND/EXPERIENCE

MINIMUM:

• Bachelor's Degree or equivalent in biology, animal science, or a relevant science field.

DESIRABLE:

• Master's degree or equivalent in biology, animal science, or a relevant science field.

WORKS EXPERIENCE/SKILLS

MINIMUM:

• At least 5 years of relevant auditing experience in veterinary pharmacovigilance or related regulatory environments.
• Experience with deviation/CAPA processes and documentation.
• Experience in managing people.
• Proficiency in Microsoft Office suite (Word, Excel, Outlook).
• Excellent interpersonal, communication, negotiation, risk assessment, and problem-solving skills.
• Ability to work independently, foster good remote relationships, and handle multiple tasks.
• Willingness and ability to travel as needed.

DESIRABLE:

• Over 10 years of experience supporting animal health trials in a research quality assurance role.
• Over 5 years of managing teams.
• Experience conducting pharmacovigilance audits and participating in regulatory inspections.
• Experience with pharmacovigilance databases.
• Understanding of current regulatory requirements for animal product registration in major global markets.
• Experience auditing non-clinical and clinical veterinary studies, facilities, CROs, and related processes.