Position Summary

The Director of Quality Systems and Audits is responsible for leading the design, implementation, and oversight of quality systems that ensure compliance with cGMP regulations, regulatory requirements, and internal policies in a biotechnology manufacturing environment. This role provides strategic direction, manages audit programs, and drives continuous improvement across quality systems to support product quality, patient safety, and business objectives. This role will also promote a culture of proactive quality, compliance, and accountability across the organization. 

Essential Functions (ES) and Responsibilities

• Lead the development, implementation, and maintenance of robust Quality Management Systems (QMS) aligned with FDA regulatory standards.
• Oversee internal, external, and supplier audit programs, including planning, execution, reporting, and follow-up on corrective and preventive actions (CAPAs).
• Manage regulatory inspection readiness activities, coordinate inspection hosting, and ensure timely and effective response to inspection findings.
• Participate in Quality System Review Boards, ensuring escalation and resolution of key quality and compliance issues.
• Partner with functional leaders in Manufacturing, QC, R&D, Facilities and Supply Chain to ensure alignment and integration of quality systems across operations.
• Lead initiatives for continuous improvement in quality systems, including electronic systems (eQMS), risk management, and data integrity practices.
• Provide training, guidance, and mentorship to quality and operational staff on audit processes, QMS requirements, and best practices.
• Serve as a subject matter expert (SME) in quality systems during regulatory agency inspections.
• Analyze data and quality trends, identifying root causes, implementing corrective actions, and preventing future quality deviations.
• Drive supplier quality management initiatives, establishing robust supplier evaluation and qualification processes.
• Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance with manufacturing and testing of company products.
• Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
• Serve as a liaison between our company's senior management and the suppliers to identify quality issues and come up with solutions.
• Ability to travel domestically up to 25%

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Bachelor’s degree in Life Sciences, or related field; advanced degree preferred.
• 12+ years of experience in Quality Assurance, Quality Operations, or Manufacturing QA leadership roles.
• 5+ years of experience in a professional management role
• Strong knowledge of FDA and ICH guidance.
• Proven track record in managing audits, inspections, and quality systems in a GMP environment.
• Strong leadership, project management, and cross-functional collaboration skills.
• Excellent communication, problem-solving, and decision-making abilities.
• Experience with electronic quality systems (eQMS, LIMS, TrackWise, Veeva, or similar).
• Demonstrated leadership and team management experience.

Preferred Experience

• Demonstrated ability to build and lead high-performing teams
• Experience scaling quality operations in rapidly growing environments
• Strategic leadership and organizational influence
• Audit and compliance expertise
• Quality system design and continuous improvement
• Regulatory inspection readiness and hosting
• Risk-based decision making
• Strong interpersonal and mentoring
• Strategic thinker with ability to execute in a fast-paced environment
• Excellent collaboration and influence skills across functions and levels
• High integrity, sound judgment, and commitment to patient safety and product quality

Compliance Requirements (ES)