Senior Director, Quality Assurance

Monitor, measure and report on quality issues, opportunities and development plans and achievements within agreed formats and timelines to direct reports as well as department leaders in Manufacturing, Compliance, Facilities/Engineering, Supply Chain, Quality Control, Human Resources as well as Senior Management. 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.

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’s specialty plasma-derived products. This leader will ensure that materials, processes, facilities, and products meet applicable regulatory requirements and company’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.

Responsibilities

• 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 members of the team.
• As a member of senior management, works collaboratively and cross-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 during FDA 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 development plans and achievements within agreed formats and timelines to direct reports as well as department leaders in Manufacturing, Compliance, Facilities/Engineering, Supply Chain, Quality Control, Human Resources as well 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 escalate 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 cGMP compliance.
• 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.

Qualifications

• 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 experience leading investigations, risk assessments, change control, system and process validation oversight, batch disposition, and inspection preparation.
• Proven ability to make defensible quality decisions, communicate effectively with senior leaders and regulators, and lead teams through complex issues.
• Strong written communication, organizational, and people leadership skills.

Base salary range: Up to $285,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.