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.

Work arrangement
Yes