Director, Global Quality Assurance, GVP

Zenas BioPharma; Waltham (MA); On-site; USD 176,000 - 220,000; Full time

Job summary

A global biopharmaceutical company is seeking a Director of Global Quality Assurance, GVP to oversee quality assurance for clinical trials and ensure compliance with regulatory standards. The ideal candidate has over 10 years of experience in global QA, strong leadership skills, and a background in pharmacovigilance. This role offers a competitive salary and benefits, including bonuses and equity.

Benefits

Annual performance bonus

Equity

Comprehensive health benefits

Retirement plans

Qualifications

• 10+ years in global QA with expertise in GVP.
• Strong knowledge of regulatory requirements (FDA, EMA, ICH‑GCP).
• Proven experience in managing audits and inspections.

Responsibilities

• Lead GVP QA strategy and daily activities.
• Drive process improvement and ensure quality standards.
• Provide executive-level reporting of compliance risks.

Skills

GVP expertise

Leadership

Communication

Analytical skills

Interpersonal skills

Education

Bachelor’s degree in Life Sciences or related field

Tools

Safety systems (e.g., Argus, ArisG, Veeva Safety)

Job description

Join to apply for the Director, Global Quality Assurance, GVP role at Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company dedicated to developing and commercializing immune‑based therapies worldwide. With clinical development and operations globally, Zenas is advancing a deep, balanced global portfolio of first‑ and best‑in‑class autoimmune therapeutics in high unmet medical need areas, while meeting dynamic value requirements in the global healthcare environment. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve lives of patients living with autoimmune and rare diseases.

Position Summary

The Director of Global Quality Assurance, GVP serves as a key quality partner across global clinical trial and pharmacovigilance teams. The role leads, oversees, and executes Good Pharmacovigilance Practices (GVP) activities, supporting high‑quality standards, mitigating risks, driving process improvement, and ensuring inspection readiness. This position reports to the Head of Global QA, Clinical Operations and Development.

Key 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 align 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, 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 maintain organizational compliance.
• 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) 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 to deliver value‑added business results.
• 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%).

Compensation & Benefits

Base salary range: $176,000 to $220,000 per year.
Additional compensation includes annual performance bonus, equity, and a full range of benefits such as health, dental, vision, retirement plans, and other incentive compensation.

Zenas BioPharma is proud to be an equal‑opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.