Senior Director Quality Assurance

Position Summary

The Senior Director of Quality Assurance Systems provides strategic and operational leadership for the company’s global GxP Quality Management System across manufacturing, packaging, laboratories, warehouses, IT, and external partners. This position ensures compliance with all applicable regulations, maintains inspection readiness, and drives continuous improvement in quality performance and systems.

Key Responsibilities

Leadership & Oversight

• Lead Quality System functions including Document Control, External Quality, and Quality Systems teams.
• Develop, mentor, and retain staff through effective coaching, clear performance goals, and succession planning.
• Foster a quality-driven culture emphasizing accountability, collaboration, and continuous improvement.
• Coordinate cross-functional communication with Manufacturing, R&D, Supply Chain, and Regulatory Affairs to ensure quality alignment.

Quality Systems & Compliance

• Oversee implementation, maintenance, and improvement of the company’s global GxP Quality Management System.
• Ensure inspection readiness through internal audit management, CAPA effectiveness, and regulatory inspection support.
• Direct the document control system, ensuring lifecycle management and data integrity.
• Lead Quality Council and Change Approval Board (CAB) processes for risk assessment, change control, and supplier approval.
• Maintain approved supplier listings, oversee vendor audits, and ensure quality agreements are current.
• Review and approve deviations, risk assessments, and product disposition decisions.

Strategic & Continuous Improvement

• Establish and track quality metrics, identify trends, and lead corrective or preventive actions.
• Manage Quality Risk Register and prioritize remediation plans.
• Drive improvement initiatives to enhance quality system performance and operational efficiency.
• Stay current with FDA, EMA, and ICH regulations, providing leadership in adapting systems to evolving standards.

Qualifications

Education:

• Bachelor’s degree in a science or engineering discipline required.
• Advanced degree (MS, PhD, or MBA) preferred.

Experience:

• Minimum 15 years in the pharmaceutical industry with at least 10 years in a senior quality leadership role.
• Broad QA experience across auditing, investigations, complaints, cGxP systems, and commercialization support.
• Direct experience with FDA inspections and regulatory agency interactions.
• Proven ability to develop, implement, and sustain compliant, efficient quality systems.
• Experience managing External Quality (CMO, suppliers) preferred.

Skills & Attributes:

• Expert understanding of FDA, ICH, and cGMP regulations.
• Strong leadership, decision-making, and conflict resolution skills.
• Excellent communication and presentation abilities.
• Proven ability to lead cross-functional teams and influence at all organizational levels.
• Strategic thinker with a practical, results-oriented approach.

Work Environment

• On-site leadership role in a regulated manufacturing and laboratory environment.
• Occasional travel required for audits, inspections, and external quality oversight.