The Senior Manager, Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (e.g., batch records), leads investigations and root cause analyses for deviations, corrective and preventive actions (CAPAs), manages change controls, and ensures compliance with quality and CGMP regulations. This role also supports validation, automation, data integrity, environmental reports and facility reports while collaborating with internal stakeholders and clients on clinical and GMP events.

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Major Accountabilities: 

• Manages a team of quality specialists and sets the direction and priorities to ensure a successful execution of projects and tasks
• Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectivenessSupports client and regulatory inspections and serves as the subject matter expert (SME) for Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls
• Problem solves with the team and determines effective solutions and root causes
• Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Encourages a culture prioritizing continuous learning and development, including coaching and mentoring to position the team for growth
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Performs other duties, as assigned

Knowledge, Skills, or Abilities: 

• Effective communication, both written and oral
• Ability to lead teams, projects, and programs while effectively allocating resources
• Ability to remain up to date on regulatory and quality requirements
• Ability to effectively present information to others
• Advanced knowledge of clinical and GMP manufacturing
• Ability to continuously improve and utilize the PDCA method and create business processes
• Ability to lead problem-solving sessions, such as fish bone, 8-step problem solving, 5 Why’s and FMEA

Minimum Education and Experience Requirements: 

• Master’s degree in quality, business management or other related field with 7+ years of related experience; or
• Bachelor’s degree in quality, business management or other related field with 9+ years of related experience
• 2-5 years of people management and leadership experience
• Prior experience working in a CDMO

Preferred Education and Experience Requirements:

• 5+ years of people management and leadership experience

Preferred Training or Certification Requirements: 

• Root Cause Analysis training
• Problem-solving training

*LI-Onsite

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).