QA Operations Supervisor - Drug Product

Position Overview

This position supports a Monday-Friday 3pm-11:30pm shift schedule. In the future, this will shift to a 2/2/3 6am-6pm or 6pm-6am schedule.

The QA Operations Shift Supervisor is responsible for providing day-to-day supervision and risk-based QA support of the Drug Product Manufacturing area 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

• Provides day-to-day supervision of the Quality Assurance (QA) Operations Drug Product (DP) Team.
• 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 area 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, AQL), QA support activities (e.g. deviation/CAPA review and approval, clearance and area release), and technical QA activities (e.g. Change Control review and approval, WO oversight).
• Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach.
• Collaborates with Responsible Person(s) to facilitate timely disposition of DP material.
• Serves as Subject Matter Expert (SME) in audits and inspections for DP 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. Works 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.
• Other duties, as assigned.

Knowledge, Skills, or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills, organization and planning skills.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Positive attitude to embrace a dynamic work environment.
• Knowledge of Technology Transfer and/or Product Commercialization processes.
• Occasional opportunity for International and/or Domestic travel may be available.
• Ability to coach, lead, and develop individual contributors.
• Ability to effectively present information to others.
• This role supports a 24/7 operations environment and requires working nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Upon hire, the position will be assigned to second shift on a 5x8 schedule and is eligible for shift differential in accordance with Company policy. The role is expected to transition to a 2-2-3, 12-hour rotating schedule, with shift differential eligibility per policy. The timing of the transition will be communicated in advance and is subject to business needs.

Minimum Requirements:

• Bachelor’s degree with 4+ years of experience from a similar role.
• 2+ years of team management experience.
• Experience leading, supervising, or managing others.
• Experience working in a regulated GMP environment.

Preferred Requirements:

• Understanding of formulation, aseptic filling and/or visual inspection.
• Working knowledge and experience with Trackwise, Veeva, PAS-X, Smartsheet and/or Kneat..
• Experience with startup projects.
• High level of familiarity/understanding of hygienic utilities, quality systems, automation, manufacturing and IT systems, and validation of production equipment.
• Understanding of Data Integrity and application of 21 CFR Part 820 and Part 11.

Working Conditions & Physical Requirements:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time, up to 120 minutes.
• Ability to sit for prolonged periods of time, up to 120 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.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environment, 2-8 degrees C.

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.

*LI-Onsite

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 ([email protected]).