Director, Quality Assurance Operations

Position Overview

The Director of Quality Assurance Operations provides strategic leadership and oversight for Quality Assurance activities supporting commercial and clinical manufacturing, distribution, and supply chain operations. As a senior member of the Quality leadership team, this role partners with management to develop and execute quality operations and compliance strategies that support corporate objectives, regulatory requirements, and business growth.

The Director maintains accountability for the effectiveness of Quality Operations programs, directs departmental activities through staff, and serves as the final Quality decision-maker for assigned operational quality matters. The position is accountable for departmental budget management, resource planning, organizational effectiveness, and quality compliance outcomes across internal operations and external business partners.

Key Responsibilities

• Develop and execute the Quality Operations strategy in partnership with senior leadership to support commercial and development programs.
• Participate with senior management in establishing long-term quality, compliance, inspection readiness, and operational objectives.
• Direct quality operations activities across multiple functional areas. Accountable for overall departmental performance and achievement of strategic objectives.
• Establish department goals, performance metrics, and resource plans aligned with organizational priorities and business objectives.
• Identify, evaluate and communicate product quality and compliance risks and drive mitigation strategies. Serve as the final Quality authority for operational quality decisions impacting assigned products, processes and compliance programs. Make final decisions regarding quality risk assessments, compliance remediation plans and escalation actions.
• Lead a multi-level Quality organization and develop Quality Assurance Operations personnel. Exercise authority for hiring, performance management, compensation recommendations, promotions, succession planning, disciplinary actions, and terminations.
• Approve staffing plans and workforce allocations. Allocate departmental resources to achieve business and compliance objectives. Provide strategic leadership for departmental organization design and resource planning.
• Establish strong relationships with contract Quality organizations to ensure timely resolution of quality issues
• Partner with the internal project teams to ensure adherence to Quality Management System (QMS) requirements and drive best practices in quality record generation and closure
• Direct lot disposition activities in support of commercial and clinical supply demands. Serve as the Quality approver for product disposition decisions and quality-related supply chain actions.
• Support the development, and review of Annual Product Reviews (APRs), contributing quality-related content and advising on improvements based on identified trends, findings, and risks.
• Oversee GDP and DSCSA compliance activities to ensure compliant distribution, product traceability, and supply chain security
• Oversee artwork management processes to ensure compliant control, approval, and implementation of labeling and packaging materials
• Manage third-party audits and participate in internal audits as well as regulatory inspections
• Review regulatory submission documentation related to NDAs, BLAs, INDs, information requests and annual reports
• Analyze, report, and present metrics to functional teams and Quality management; Identify any risks and recommend any required actions and monitor implementation of mitigation or preventive actions
• Author, review, and/or approve internal policies, procedures and quality documentation
• Develop, manage and maintain accountability for the Quality Operations budget. Approve departmental expenditures and resource allocations. Monitor financial performance and implement corrective actions to achieve budget objectives. Provide budget forecasts and investment recommendations to senior leadership.

Qualifications

• B.S. degree preferably in a scientific discipline
• Ten (10) years of Pharmaceutical/Biopharmaceutical industry experience with seven (7) years of Quality Assurance experience in US/EU environments preferred
• Seven (7) years of direct supervisory experience with increasing responsibility over time preferred
• Electronic Quality system applications (e.g., eDMS, QMS); Veeva Vault experience preferred
• Experience participating in/hosting regulatory inspections and interacting with regulators preferred
• Experience with commercial GxP processes including Good Distribution Practices and Drug Supply Chain Security Act (DSCSA)
• Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application
• Direct experience managing Quality System activities within regulated pharmaceutical or biotechnology environments
• Knowledge of the drug development and commercialization process
• Proficiency with Quality system applications (e.g.,eDMS, QMS)
• Comprehension of appropriate escalation regarding Quality as well as product and/or patient safety issues
• Excellent written and verbal communication skills
• Strong planning and organizational skills
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Comfortable working independently with minimal supervision
• Results driven, problem solver, and collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation
• Ability for travel up to 20% of the time