Director of Quality

Director Of Quality

The Director of Quality provides strategic leadership for all quality and compliance functions at the Tonawanda, NY site and serves as a key member of the site leadership team. This role is responsible for establishing and maintaining a robust quality culture that ensures product quality, patient safety, regulatory compliance, and continuous improvement across site operations.

This position oversees all site quality systems and ensures compliance with applicable regulatory requirements, including Section 503B of the U.S. Food, Drug & Cosmetic Act, current Good Manufacturing Practices (cGMP), OSHA, environmental, labor, and other applicable governmental regulations. This role ensures facility operations, processes, equipment, and documentation systems are maintained in a state of compliance.

The Director of Quality serves as the quality representative to regulatory agencies, including the United States Food and Drug Administration (FDA) and other health authorities. Responsibilities include coordinating inspection readiness activities, and ensuring timely and effective responses to regulatory inquiries, observations, and commitments.

This role is responsible for developing and executing site quality strategies and initiatives that align with organizational goals. This includes oversight of quality assurance, quality control, compliance programs, risk management activities, deviation investigations, CAPA effectiveness, change control, and continuous improvement initiatives.

The Director of Quality leads, mentors, and develops the quality organization by building high-performing teams, setting clear expectations, and fostering employee growth through hiring, coaching, training, and performance development. The Director partners cross-functionally with Operations, Regulatory, Engineering, and other departments to drive operational excellence while maintaining the highest quality standards.

Essential Functions:

• Provide strategic leadership and oversight for all Quality Assurance, Quality Control, and Compliance functions to ensure product quality, patient safety, and regulatory compliance.
• Lead, develop, mentor, and manage quality personnel and consultants by establishing performance expectations, driving accountability, and supporting professional development.
• Ensure site-wide compliance with Section 503B of the U.S. Food, Drug & Cosmetic Act, current Good Manufacturing Practices (cGMP), OSHA, environmental, labor, and other applicable regulatory requirements related to facilities, utilities, warehousing, manufacturing, testing, documentation, training, and record management.
• Oversee and continuously improve site quality systems, including but not limited to Change Control, Deviations, Investigations, Corrective and Preventive Actions (CAPA), Complaint Management, Validation, Risk Assessments, and document control systems.
• Serve as a site representative during regulatory inspections, customer audits, and interactions with the FDA and other health authorities, including leading inspection readiness activities and ensuring timely responses to regulatory observations and inquiries.
• Establish and monitor key quality metrics, KPIs, quality event trends, Annual Product Reviews, and other performance indicators to identify risks, drive continuous improvement, and support operational excellence.
• Provide quality oversight for laboratory operations, including QC testing activities, environmental monitoring programs, and overall laboratory compliance.
• Assists with all aspects of quality systems, such as Change Control, Investigations, Corrective/Preventive Action, Validation systems to ensure compliance and timely and accurate completion of reporting events.
• Oversee supplier qualification programs, internal audits, external audits, and vendor quality management activities to ensure compliance throughout the supply chain.
• Manages and/or executes the planning, conducting, and reporting of QA batch disposition functions for cGMP manufacturing and distribution activities.
• Partner cross-functionally with Operations, Regulatory Affairs, Engineering, Supply Chain, and executive leadership to support organizational goals while maintaining compliance and quality standards.
• Drive a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
• Review and approve quality-related procedures, policies, specifications, protocols, reports, and other controlled documents to ensure compliance and operational effectiveness.
• Performs duties in accordance with established company procedures and policies; performs other duties as assigned.

Education and Experience:

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or a related scientific discipline required. Advanced degree (MS, MBA, PharmD, or similar) preferred.
• Minimum of 12+ years of progressive experience in Quality Assurance, Quality Control, Compliance, or related pharmaceutical manufacturing environments.
• Minimum of 5+ years of leadership experience managing quality teams within pharmaceutical, biotechnology, compounding, or regulated manufacturing operations.
• Strong knowledge of Section 503B, current Good Manufacturing Practices (cGMP), FDA regulations, aseptic processing, and applicable industry guidance.
• Familiarity with manufacturing processes and operations with a strong focus on equipment and facilities validation.
• Experience participating in FDA inspections, customer audits, and regulatory agency interactions, including managing responses to observations and regulatory commitments.
• Demonstrated experience overseeing quality systems such as deviations, CAPA, change control, validation, risk management, and batch release activities.
• Experience working in sterile manufacturing, compounding, or aseptic processing environments strongly preferred.
• Strong leadership, communication, problem-solving, and cross-functional collaboration skills.

Knowledge, Skills and Abilities:

• Proven leadership ability to build, mentor, and develop high-performing teams while fostering accountability and collaboration.
• Excellent problem-solving and decision-making skills with the ability to assess risk and make sound quality-based decisions.
• Excellent written and verbal communication skills, including the ability to communicate effectively with executive leadership, regulators, auditors, and cross-functional teams.
• Strong analytical skills with experience interpreting quality metrics, trends, KPIs, and Annual Product Reviews to drive continuous improvement.
• Thorough understanding of quality control standards and methodologies.
• Thorough understanding of manufacturing and production in the industry.
• Strong organizational and project management skills with the ability to lead complex initiatives and drive results.
• Ability to manage multiple priorities in a fast-paced, highly regulated environment.
• Proficiency in quality systems software, Microsoft Office applications, and electronic documentation systems.