Director, Global Quality Assurance, GVP

Zenas BioPharma-posted 2 months ago
$176,000 - $220,000/Yr
Full-time • Senior
Waltham, MA
101-250 employees
Professional, Scientific, and Technical Services
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Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!

  • 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.
  • 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%].
  • Annual performance bonus
  • Equity
  • Full range of benefits
  • Other incentive compensation plans
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