Director Quality Operations

The Director, Quality Operations is a senior leadership role responsible for overseeing site-wide quality systems and ensuring compliance with applicable regulatory requirements, industry standards, and internal quality standards. This individual serves as the quality leader for the manufacturing site, providing both strategic direction and operational oversight across quality functions.

Reporting to senior quality leadership, this role is accountable for maintaining a robust Quality Management System (QMS), supporting commercial manufacturing operations, ensuring product quality and patient safety, and fostering a culture of continuous improvement. The Director partners closely with cross-functional teams to drive compliance, operational excellence, inspection readiness, and risk management throughout the organization.

The position provides leadership for Quality Assurance, Quality Control, Microbiology, Validation, Aseptic Operations support, Contamination Control, Training, Quality Systems, and Regulatory Compliance activities. As a member of the site leadership team, this individual plays a key role in supporting business objectives while maintaining the highest standards of quality and regulatory compliance.

Essential Responsibilities

• Develop and execute quality strategies that support business goals, regulatory compliance requirements, and customer expectations. Provide leadership and direction across all site quality functions while ensuring alignment with corporate quality standards. Establish quality objectives and key performance indicators to monitor organizational effectiveness and support continuous improvement initiatives.
• Lead, mentor, and develop quality teams to create a culture of accountability, collaboration, and operational excellence. Build strong relationships across manufacturing, engineering, supply chain, technical services, validation, and regulatory functions to ensure quality considerations are integrated into business decision-making.
• Serve as the primary quality representative during regulatory inspections, customer audits, and external assessments. Lead responses to audit observations, inspection findings, and remediation efforts while maintaining a state of inspection readiness across all quality and manufacturing operations.
• Oversee the site's Quality Management System, including deviation management, investigations, CAPA programs, change controls, risk assessments, complaints, and document management processes. Ensure quality systems remain effective, compliant, and aligned with evolving regulatory requirements.
• Provide quality oversight of commercial manufacturing activities, product release operations, laboratory testing, validation activities, environmental monitoring programs, contamination control strategies, and sterility assurance initiatives where applicable. Ensure raw materials, components, intermediates, and finished products meet established quality standards prior to release.
• Partner with Quality Control and Microbiology teams to ensure laboratory operations are performed in compliance with established procedures and regulatory requirements. Ensure investigations are thorough, scientifically sound, and supported by effective root cause analysis and corrective actions.
• Support supplier quality programs through qualification, auditing, performance monitoring, and ongoing compliance activities. Collaborate with external manufacturing, testing, and service providers to ensure adherence to company quality expectations and regulatory standards.
• Drive quality risk management initiatives by leveraging quality metrics, trend analysis, and performance data to identify improvement opportunities. Implement proactive solutions that enhance product quality, strengthen compliance, and improve operational efficiency.
• Lead management review activities and provide regular updates to senior leadership regarding quality performance, compliance status, inspection readiness, emerging risks, and continuous improvement efforts. Support technology transfers, process improvements, product launches, and other strategic initiatives as needed.
• Ensure all manufacturing, testing, packaging, storage, and distribution activities comply with applicable global regulations, industry standards, and internal quality requirements while maintaining a strong focus on patient safety and product reliability.
• Perform additional responsibilities as assigned to support business and quality objectives.

Qualifications

• A Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, Pharmacy, or a related technical discipline is required. An advanced degree is preferred.
• The successful candidate will possess significant progressive leadership experience within pharmaceutical, biotechnology, biologics, medical device, or other highly regulated manufacturing environments. Experience leading Quality Assurance, Quality Control, Quality Systems, and compliance organizations is strongly preferred.
• Demonstrated success supporting regulatory inspections, managing audit responses, and maintaining compliance within FDA, EMA, and other global regulatory frameworks is essential. Experience with sterile manufacturing, aseptic processing, biologics, injectable products, combination products, or other complex manufacturing environments is highly desirable.
• The ideal candidate will have a deep understanding of cGMP regulations, quality systems, validation programs, laboratory operations, manufacturing processes, supplier quality management, and risk management principles. Experience working with contract manufacturing organizations and external suppliers is advantageous.
• Strong analytical, problem-solving, and decision-making abilities are required, along with excellent communication and stakeholder management skills. The ability to influence cross-functional teams, drive organizational change, and effectively communicate with executive leadership, regulatory authorities, and external partners is critical to success in this role.
• This position requires a strategic leader who can balance quality, compliance, operational performance, and business objectives while ensuring the consistent delivery of safe, effective, and high-quality products.