The Senior Manager, Quality Compliance is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team regarding Inspection Readiness, Site Internal Audits, and Quality Management Review (QMR). This role focuses primarily on creating and maintaining the site internal audit plan and performing associated audits. Additionally, the future-state of this role is to also lead and develop a Quality Assurance (QA) compliance team.

At FUJIFILM Diosynth Biotechnologies U.S.A., 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 Diosynth 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

What You’ll Do

• Creates and maintains site self-inspection plan and performs site self-inspections and regulatory inspections
• Coordinates all preparation activities to support inspections, including but not limited to audit execution, timely observation follow up, providing report responses on behalf of the site, and internal follow up
• Seeks continuous improvement opportunities learned from audits/inspections and the PQS process
• Leads Inspection Readiness activities and effectively communicates the inspection and audit timelines
• Acts as the site Business Process Owner (BPO) for Inspection Readiness and Audits
• Participates in data gathering and generation for site and global QMR
• Supports creation and maintenance of quality assurance policies for all quality subsystems, including learning set up for PQS, including global processes
• Interfaces with Regulatory Affairs and BPOs to develop robust compliance processes, implements quality system strategies, facilitates continuous improvement of PQS, and interprets and implements QA standards within PQS
• Maintains professional working knowledge of relevant regulations, documents, and standards, and identifies best practices within the company
• Provides QA oversight and support of project deliverables in accordance with governing processes and procedures for PQS
• Contributes to developing and maintaining QA documentation, procedures, and processes for company and site objectives and QA support of manufacturing operations in a Current Good Manufacturing Practice (CGMP) regulated facility
• Participates in streamlining and efficiency improvement initiatives with other FDB sites
• Leads continuous improvement projects related to systems, processes, and documentation while serving as the sites’ subject matter expert (SME)
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Coaches and mentors direct reports to ensure the team is positioned for growth
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Knowledge and Skills

• Collaborative attitude with the willingness to work with global colleagues and cross-functional teams toward company and department goals
  
• Excellent communication skills, both written and oral
  
• Attention to detail and commitment to maintaining quality standards
  
• Strong knowledge of software QA methodologies, tools, and processes
  
• Strong analytical and problem-solving skills
  
• In-depth knowledge of biotech product regulatory requirements
  
• Ability to effectively present information to others
  
• Knowledge and application of CGMP compliance and other related regulations
  
• Ability to coach, lead, and develop individual contributors
  
• Must be flexible to support 24/7 manufacturing facility

Basic Requirement

• Bachelor’s degree in Life Science or Engineering with 9+ years of applicable industry experience; or
• Master’s degree in Life Science with 7+ years of applicable industry experience; or
• PhD in Life Science with 5+ years of applicable industry experience
• 5+ years of people management & leadership experience
• 3+ years of experience in GMP QA or similar role

Preferred Requirements 

• Experience in Validation, CGMP Manufacturing Operations and/or Quality oversight in an FDA regulated facility

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

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).