Director, Global Quality Assurance, GVP

Role Summary

The Director of Global Quality Assurance, GVP is responsible for leading and overseeing Good Pharmacovigilance Practices activities. In this role you will serve as a key quality partner across global clinical trial and pharmacovigilance teams, supporting the maintenance of high-quality standards, mitigating risks, process improvement, and ensuring inspection readiness. This role reports to the Head of Global QA, Clinical Operations and Development.

Responsibilities

• Apply depth and breadth of GVP expertise while performing QA oversight for multiple studies/CROs.
• Drive the global GVP QA strategy and execute day to day activities to ensure alignment with corporate objectives and regulatory expectations.
• Partner cross-functionally to ensure integrated quality oversight and consistent application of GVP principles.
• Lead or support internal and external audits of PV processes, systems, and documentation to verify compliance with GCP, Good Pharmacovigilance Practices (GVP), and applicable regulations.
• Identify potential quality risks in pharmacovigilance processes and implement proactive mitigation strategies. Drive continuous improvement initiatives in quality systems and processes.
• Establish and track KPIs and quality metrics to evaluate the effectiveness of QA activities and identify areas for improvement.
• Ensure PV Quality Agreements with business partners are defined, implemented, and monitored.
• Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
• Contribute to budget planning and resource allocation for GVP QA and PV audit programs.
• Oversee the maintenance of quality documentation, SOPs, and audit trail integrity related to pharmacovigilance activities.
• Provide expert interpretation of evolving global pharmacovigilance regulations and guide senior leadership on compliance impact.
• Ensure all pharmacovigilance activities adhere to applicable regulations (e.g., ICH-GCP, FDA, EMA), company policies, and industry standards.
• Stay current with industry trends, regulations, and best practices to ensure the organization remains compliant.
• Prepare the organization for external inspections by regulatory authorities, ensuring documentation and processes are inspection ready.
• Interact with third-party vendors and business partners to ensure compliance with Quality standards.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; (e.g., MSc, PharmD, PhD) preferred.
• 10+ years in global QA with significant expertise in GVP; strong cross-functional background in GCP and regulatory compliance.
• Strong knowledge of global regulatory requirements (FDA, EMA, MHRA, Health Canada ICH-GCP, GVP) pertaining to pharmacovigilance.
• Experience with safety systems (e.g., Argus, ArisG, Veeva Safety, or equivalent) and oversight of validated systems.
• Proven experience in managing audits and inspections and direct interaction with regulatory authorities in a pharmacovigilance environment.
• Strong leadership, communication, and interpersonal skills.
• Ability to influence and build relationships across cross-functional teams.
• Detail-oriented with strong analytical and problem-solving skills.
• Demonstrated ability to act as both a functional leader and an individual contributor capable of defining and driving work independently.
• Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk delivering value-added business results that meet high-quality requirements with tight deadlines.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Ability to travel to and work from the Zenas headquarters monthly and internationally as needed (up to 25%).

Skills

• Quality assurance leadership
• GVP and GCP regulatory knowledge
• Audit and inspection management
• Regulatory liaison and stakeholder management
• Risk assessment and mitigation
• Quality metrics and KPI development

Education

• As listed in Qualifications

Additional Requirements

• Travel up to 25% may be required.