Senior Director of Quality Assurance

Position Summary:

We are seeking a dynamic and experienced Senior Director of Quality Assurance with a speciality in GMP and GLP, to lead and enhance our quality assurance function. This role is ideal for a strategic leader with a proven track record in right-sized GMP & GLP organizations, focusing on phase-appropriate QMS design and implementation. They will ensure that products, services, and processes comply with established quality standards, regulatory requirements, and customer expectations while fostering a culture of continuous improvement. Leading teams in Quality Systems, Quality Operations, and GMP/GLP Audits and Risk Management, this individual will play a crucial role in shaping quality strategy.

Key Responsibilities:

• Develop and implement comprehensive GMP/GLP quality assurance strategies, policies, and procedures in alignment with the companies goals and industry best practices.
• Define and monitor key quality metrics and performance indicators to drive continuous quality improvement.
• Manage and mentor a team of quality assurance professionals, fostering a culture of coaching, development, and professional growth.
• Analyse quality data to identify trends, root causes of defects, and implement corrective and preventive actions.
• Provide regular updates on GMP/GLP risks and risk management strategies to senior leadership.
• Stay informed about regulatory changes and ensure timely updates to quality processes.
• Work closely with key stakeholders across departments, including Human Subject Research QA, Development, Manufacturing, Regulatory Affairs, and General & Administrative functions, to integrate quality considerations into all aspects of operations.
• Identify and implement process improvements to enhance product quality, operational efficiency, and overall compliance.
• Promote a culture of quality through continuous learning, innovation, and feedback mechanisms.

Education & Experience:

• Bachelor’s degree in Life Sciences or a related field required.
• Minimum of 15 years of QA experience, including at least 7 years in leadership roles within GMP/GLP organizations.
• Experience in mid-to-late-stage drug development required.
• Minimum of 7 years managing direct reports, with preference for experience leading global, cross-cultural teams.

Qualifications & Skills:

• Expertise in biologics and/or vaccines required.
• Strong presentation skills with the ability to communicate complex information clearly and concisely.
• Excellent interpersonal, oral, and written communication skills.
• Ability to influence, inspire, and drive quality initiatives in a dynamic, growth-oriented environment.
• Strong project management capabilities.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project).