Senior Director, Quality Assurance

The Senior Director, Quality Assurance, is responsible for leading and executing the QA strategy for strong oversight of the end-to-end production for company’sspecialty plasma-derived products. This leader will ensure that materials,processes, facilities, and products meet applicable regulatory requirements andcompany’s strict quality standards. The role requires sound GMP judgment, strong cross-functional leadership, and the ability to resolve complex quality issues while supporting reliable product supply.

• Lead and develop the QA teams responsible for manufacturing oversight, batch record review, product disposition, and quality systems execution.
• Provide operational leadership and expertise in the development,implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product quality complaints.
• Provide independent quality oversight of plasma manufacturing operations,aseptic filling, packaging, and associated laboratory and support activities,as applicable.
• Responsible for ensuring organizational goals are transmitted and communicated effectively throughout the QA department to include all membersof the team.
• As a member of senior management, works collaboratively andcross-functionally with other key leaders to ensure execution of department(s) and organizational goals. Assigns resources according to priority and project needs.
• Establish performance measures and use quality trends to identify emerging risks, set priorities, and drive continuous improvement.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of manufacturing, facility, and process-related changes.
• Provide leadership and direction during the investigation of deviations and quality related events.
• Support inspection readiness and serve as a senior QA representative duringFDA and other regulatory inspections, audits, and responses.
• Maintain strong oversight of suppliers, contract service providers, and material quality issues in partnership with relevant functions.
• Build a culture of accountability, clear documentation, timely escalation,and patient-focused decision-making.
• Conduct regular audits and inspections, identifying areas for improvement and ensuring compliance with applicable quality standards.
• Directs the activities of the quality assurance staff by recruiting, hiring,orienting, and training employees.
• Encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance reviews.
• Participate in project teams and/or working groups, as required.
• Monitor, measure and report on quality issues, opportunities and developmentplans and achievements within agreed formats and timelines to direct reportsas well as department leaders in Manufacturing, Compliance,Facilities/Engineering, Supply Chain, Quality Control, Human Resources aswell as Senior Management.
• Build effective partnerships while maintaining QA’s independent authority.
• Demonstrated ability for analytical and systematic thinking. Leads through investigations, identifies root cause, and ensures corrective actions are effective.
• Use quality metrics and trends to identify risk and improve performance.
• Present complex issues clearly to leadership team and escalated significant risks promptly.
• Ability to manage budget and resourcing and to lead a department.
• Participates in decision making related to critical topics and in decision making as to the strategic direction of the Quality group.
• Build capable teams, develop successors, and establish clear expectations for performance.
• Designs and manages quality systems and drives a company-wide culture of cGMPcompliance.
• Provides cGMP guidance to internal departments.
• External:
  Interacts with contract service providers, vendors, and third-party personnel to research, resolve issues, and provide information.
• Model integrity, documentation discipline, and a consistent focus on patients.

• Bachelor’s degree in a scientific, engineering, or related field; advanced degree preferred.
• 15+ years of progressive experience in pharmaceutical or biologics quality,including significant leadership experience in a GMP manufacturing environment.
• Experience with plasma-derived products, sterile biologics, or other complex biological manufacturing processes strongly preferred.
• Thorough knowledge of FDA regulations and applicable GMP requirements for biological products.
• Demonstrated…