Senior Director - Quality Assurance / Quality Control/Engineering

1. Quality Strategy Development:

• Develop and implement comprehensive quality strategies that align with company objectives and regulatory requirements.
• Lead continuous improvement initiatives to enhance product quality and operational efficiency.
• Support the development, implementation and continuous improvement of the Zylidac Bio’s QMS, through continual independent risk assessment and quality audit; quality issue management, and track/trend/reporting of quality data on the Agenus Quality Management system (QMS) to management. 
• Design, build, and continuously develop top tier quality assurance operations teams in connection with strategic goals, quality objectives and to scale with Zylidac Bio operations.
• Provide leadership and direction to the Global Zylidac Quality Unit (QA/QC) and maintain Zylidac QA/QC/QE/Audit budgets.
• Coordinate and perform vendor qualification/assessments, surveillance and “for cause” audits
• Perform raw material and drug product release activities, including lot file compliance review and oversee investigations of all quality issues (i.e., Non-conformance, deviations, OOS).
• Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that Zylidac Bio maintains a state of readiness for inspection by regulatory agencies
• Develop, manage and maintain regulated document control system and regulated training/education programs

2. Regulatory Compliance:

• Ensure compliance with FDA, EMA, and other regulatory agencies’ requirements for biologics manufacturing.
• Maintain up-to-date knowledge of industry regulations and standards, ensuring the organization adheres to applicable guidelines.
• Hands-on experience implementing quality management system for drug/biologic R&D and biologic product commercialization with direct experience interacting with the FDA, EMA and other health authority inspections

3. Quality Systems Management:

• Oversee the management of quality management systems (QMS), including document control, change control, CAPA, and deviation management.
• Ensure effective implementation of quality metrics and performance indicators.
• This individual is the key point person for quality issues escalating from within the function or outside the function

4. Team Leadership:

• Lead, mentor, and develop a team of quality assurance and control professionals.
• Foster a culture of quality awareness and accountability across all departments.

5. Cross-Functional Collaboration:

• Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality considerations are integrated throughout the product lifecycle.
• Act as the primary quality representative in client interactions and regulatory inspections.

6. Risk Management:

• Identify potential quality risks and develop mitigation strategies to ensure product integrity and compliance.
• Conduct regular risk assessments and audits to monitor quality performance.

7. Training and Development:

• Implement training programs to ensure all staff are knowledgeable about quality standards and practices.
• Promote ongoing professional development within the quality unit team.

• Master’s degree in Life Sciences, Quality Assurance, or a related field; PhD preferred
• Fifteen years (15) of relevant Quality Assurance experience in the pharmaceutical or biopharmaceutical industry 
• Extensive knowledge of US GXP compliance regulations and industry practices, as well as FDA Health Canada, EU GMP and other regulatory requirements
• At least 5 years in a Quality leadership role, preferably in a CDMO environment