FUJIFILM Holdings America Corporation · 2 months ago
Senior Manager, Quality Assurance Technical
US-NC-Research Triangle Park
Full-time
Onsite
Senior Level
7+ years expFUJIFILM Holdings America Corporation is a leader in advancing biopharmaceuticals and healthcare solutions. The Senior Manager, Quality Assurance Technical is responsible for providing technical leadership and oversight for QA in a regulated pharmaceutical environment, including managing quality systems and ensuring compliance with regulations.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
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
Qualification
Required
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
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
Preferred
5+ years of people management and leadership experience
Root Cause Analysis training
Problem-solving training
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase