Supervisor, QA Operations - Nights

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 102,000 - 172,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a Supervisor for QA Operations on the night shift in Holly Springs. This role involves leading the QA team, maintaining compliance in drug substance manufacturing, and delivering training. Join a pioneering company transforming bioproduction and healthcare.

Qualifications

• Must have extensive knowledge in QA operations.
• Experience in drug substance manufacturing and GMP environments.
• Strong leadership and team management skills.

Responsibilities

• Oversee the QA Operations team during the night shift.
• Allocate adequate resources for shop floor QA activities.
• Provide training and mentorship to team members.

Skills

Quality Assurance

Supervision

GMP Experience

Education

HS diploma or GED with 8+ years experience

Associate degree in Life-Sciences and 6+ years experience

BA/BS Life Sciences Degree with 4+ years experience

Tools

Trackwise

MasterControl

Smartsheet

Job description

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The Supervisor, Quality Assurance Operations is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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

Job Description

What You'll Do

• Oversees Quality Assurance (QA) Operations Drug Substance Manufacturing (DSM) team on night shift (1800-0600 in a 2-2-3 cadence)
• Applies expertise in manufacturing QA concepts and business knowledge to act as primary point of contact for their team and first line escalation point in areas of their responsibility
• Gathers recommendations for enhancements and gaps related to their areas of responsibility and in collaboration with leadership prioritize and implement solutions accordingly
• Maintains relationships with site-based customers and global colleagues and provide updates to leadership as requested
• Ensures allocation of adequate resources for shop floor QA activities (e.g. BPR review, event triage), QA support activities (e.g. DR/CAPA review and approval, changeover and area release) and technical QA activities (e.g. CC review and approval, WO oversight)
• Collaborates with Responsible Person(s) to facilitate timely disposition of DS material
• Serves as Subject Matter Expert (SME) in audit and inspections for DSM area.
• Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
• Provides training, coaching and mentorship of their team and peers as applicable. Work with their team to identify areas of improvement, reduce blind spots and give opportunities for increasing responsibility as appropriate for each individual’s career objectives.
• 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.)
• Coaches and guides direct reports to foster professional development
• 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
  
  

Minimum Requirements

• HS diploma or GED with 8+years’ experience from similar role in large pharma/biotech operations or projects OR
• Associate degree in Life-Sciences and 6+years’ experience from similar role in large pharma/biotech operations or projects OR
• BA/BS Life Sciences Degree with 4+years’ experience from similar role in large pharma/biotech operations or projects OR
• 2-3 years of people management experience
• Experience working in a GMP environment
  
  

Preferred Requirements

• MS in Life Sciences or Engineering
• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Understanding of large-scale drug substance manufacturing processes
• Familiar with Technology Transfer and/or Product Commercialization processes
• High level of familiarity/understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT
  
  

Systems, and/or validation methodologies

• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Occasional opportunity International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles preferred
  
  

Physical And Work Environment Requirements

Ability to discern audible cues.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time up to 30 minutes

Ability to sit for prolonged periods of time up to 30 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

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.

EEO Information

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.

ADA Information

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 ([e-mail]).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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