Senior Manager, Quality Assurance Technical

Fujifilm•Research Triangle Park, NC

17h•Onsite

About The Position

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

Requirements

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
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

Nice To Haves

5+ years of people management and leadership experience
Root Cause Analysis training
Problem-solving training

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 effectiveness
Supports 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