Director, Quality Assurance

Key Responsibilities:

Quality Systems & Process Management

• Lead the implementation, maintenance, and ongoing enhancement of the company's quality systems in accordance with applicable regulatory standards.
• Oversee the administration and strategic use of the electronic quality management platform, ensuring processes are appropriately documented, maintained, and optimized.
• Manage quality-related activities, including deviations, investigations, change management, CAPAs, and other compliance matters.
• Evaluate quality metrics and emerging trends to identify opportunities for process improvement and risk reduction.
• Establish and maintain effective procedures that support consistent execution and regulatory compliance.

Cross-Functional Quality Leadership

• Partner with teams across the organization to investigate quality concerns, determine appropriate corrective actions, and ensure timely resolution.
• Coordinate with external quality contacts to address audit observations, implement remediation plans, and verify the effectiveness of completed actions.
• Facilitate quality discussions and reviews, promoting clear ownership, timely decisions, and appropriate escalation of significant issues.
• Provide quality expertise to internal stakeholders, external consultants, contractors, and service providers.
• Support the integration of quality standards and expectations across business functions and third-party relationships.

Vendor & Supplier Quality

• Oversee supplier and service provider quality activities, including qualification, performance evaluation, audit coordination, and ongoing compliance monitoring.
• Work with external quality resources to support audits, remediation initiatives, and broader quality improvement projects.
• Track outstanding findings and corrective actions to ensure appropriate documentation, follow-through, and closure.

Compliance, Audits & Risk Management

• Maintain organizational readiness for regulatory inspections and external audits.
• Identify potential compliance gaps and collaborate with stakeholders to develop and implement risk mitigation strategies.
• Communicate material quality concerns to senior leadership and ensure appropriate escalation and resolution.
• Support the continued development of quality processes as the organization and its operational needs evolve.

Qualifications:

Required

• Bachelor's degree in a relevant scientific, technical, engineering, or life sciences discipline.
• 12+ years of progressive Quality Assurance experience within biotechnology, pharmaceutical, or another regulated life sciences environment.
• Demonstrated experience overseeing quality systems and compliance programs in a GxP-regulated setting.
• Direct experience managing or administering an electronic quality management system (eQMS).
• Strong understanding of FDA requirements, ICH guidance, GxP standards, and established quality principles.
• Experience supporting or leading regulatory inspections, internal and external audits, and quality improvement initiatives.
• Ability to independently assess complex quality challenges, develop practical solutions, and drive issues through resolution.
• Strong communication and collaboration skills, with the ability to influence stakeholders across functional teams and external partners.

Preferred

• Master's degree or another relevant advanced qualification.
• Professional quality certification, such as CQA, CQE, or an equivalent credential.
• Familiarity with electronic quality platforms such as Veeva Vault Quality, MasterControl, TrackWise, or comparable systems.
• Experience working within a startup or rapidly growing biotechnology organization.
• Background establishing, expanding, or improving quality systems and infrastructure in a developing organization.