Senior Director Global Quality Assurance, Audits & Inspections

$220,000 - $290,000/Yr

Fujifilm - Montgomery, AL

Full-time - Senior

Montgomery, AL

Machinery Manufacturing

About the position

The Senior Director Global Quality Assurance, Audits & Inspections is responsible for managing audit and CAPA activities, ensuring compliance with quality management systems, and leading the development and implementation of global quality strategies at FUJIFILM Diosynth Biotechnologies. This role involves overseeing internal audit controls, leading audits and inspections, and collaborating with various functions to minimize regulatory and business risks while supporting business goals. The incumbent will also drive an innovative corporate audit and inspection program, ensuring adherence to regulatory guidelines and company policies.

Responsibilities

• Develop risk-based corporate audit strategy.
• Supervise activities related to inspection readiness, hosting and coordinating GxP inspections conducted by regulatory health authorities.
• Develop, maintain, and ensure execution of a risk-based, proactive GxP Inspection Strategy.
• Ensure development of inspection risk-analyses and risk-mitigation plans and communicate to relevant cross-functional and Quality Leadership.
• Supervise/manage collaboration with cross-functional internal and external partners to ensure a unified, optimal inspection strategy.
• Ensure development, revision, and maintenance of optimal tools, processes, and procedures for inspection readiness, coordination, and management.
• Lead a team of Quality professionals and/or consultants to carry out all defined GxP Inspection Readiness, Management, and Hosting activities.
• Collaborate with relevant cross-functional leaders to ensure a unified, optimal Inspection Readiness strategy.
• Oversee timely fulfillment of all inspection commitments and communication with Inspectorates/Health Authorities.
• Maintain an up-to-date inspection forecast and inspection outcome tracker.
• Ensure provision of lessons learned sessions after inspections, identifying trends and best practices for process improvements.
• Chair quarterly Cross-functional Inspection Oversight Committee meetings.
• Guide and/or manage the creation/revision of relevant procedures.
• Manage/review trends and report significant investigation/deviation issues to senior management.
• Manage internal auditor training program and coordinate GxP audit training as needed.
• Participate and represent Quality in meetings and discussions as needed.
• Act as Quality Delegate for the Vice President of Corporate Quality Systems as needed.
• Support development of metrics and measures for Inspection Data to drive assessment and continuous improvement.
• Participate in budget forecasting, planning, and tracking; monitor and maintain activities to stay within budget.
• Provide coaching and mentoring of team members with training/orientation/qualification of new Quality staff.
• Promote continuous improvement.
• Provide support with the GxP Inspection Management Team for other inspection types.

Requirements

• Bachelor's degree in a technical field (e.g. microbiology, chemistry, engineering, etc.) required.
• 15+ years of leadership in Quality Management Systems and excellent understanding of business processes.
• Solid experience hosting inspections and audits.
• A minimum of 10 years working in a Management role.
• Experience working in the Biopharmaceutical industry.
• Experienced in human performance processes.
• Strong technical internal audit skills, including IT audit.
• Familiar with operating conditions across diverse markets, including mature and emerging markets.
• Solid knowledge of governance, risk management, and compliance program frameworks.
• Proven experience in developing and implementing risk-based audit plans.
• High level of integrity, ethics, and professionalism.
• Ability to work collaboratively with cross-functional teams and senior management.
• Strong leadership and team management skills.
• Demonstrated knowledge of global GxP practices required.
• Knowledge of GXP regulations and guidelines as it pertains to Quality Systems.
• Ability to work with ambiguity and define a clear path forward.
• Ability to work effectively with various technical groups.
• Strong decision maker with critical thinking skills.
• Must have strong interpersonal and communication skills.
• Experience writing, reviewing, and editing SOPs.

Nice-to-haves

• Certified Auditor
• Advanced degree in a scientific discipline preferred.
• Experience in interaction with customers and establishing trusting relationships.
• Previous Organizational Change Management experience.

Benefits

• Competitive salary range of $220,000 to $290,000 based on location and experience.
• Remote work options with the requirement to reside within commuting distance of FDB US locations.