Position Summary:

The Senior Director, Quality Assurance, is responsible for leading and executing the QA strategy for strong oversight of the end-to-end production for ADMA Biologics’ specialty plasma-derived products. This leader will ensure that materials, processes, facilities, and products meet applicable regulatory requirements and ADMA’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.

Essential Functions and 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.

Job Responsibilities or Job Requirements

Competencies

Education and Experience Requirements:

Education Requirements:

• Bachelor's degree in a scientific, engineering, or related field; advanced degree preferred.

Experience Requirements:

• At least 15 years of progressive experience in pharmaceutical or biologics quality, including significant leadership experience in a GMP manufacturing environment. 
• 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.

Compliance Requirements:

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.