Deviation Supervisor

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive health benefits

Retirement plan

Paid time off

Professional development

Inclusive culture

24/7 operation support

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Supervisor, Deviation to lead a multi-functional team ensuring GMP readiness and compliant production schedules. You will oversee materials, training, and scheduling in a 24/7 environment, guiding process improvements and robust change management.

The role emphasizes leadership, cross-functional collaboration, and a strong track record in regulated biopharma manufacturing. Travel up to 25% may be required during project phases.

Qualifications

• High school diploma or GED with 6 years related experience; or
• Bachelor's Degree in Life Science, Engineering, or related field with 2 years related experience; or
• Master's Degree in Life Science, Engineering, or related field with no prior experience

Responsibilities

• Lead operational readiness initiatives to ensure GMP readiness and stand up the manufacturing support documentation team.
• Oversee commissioning activities for support functions and ensure alignment with GMP standards.
• Manage day-to-day manufacturing support including materials, training, and schedule coordination.

Skills

GMP knowledge

Leadership

Project management

Regulatory inspections

Cross-functional collaboration

Communication

Education

Bachelor's Degree in Life Science or Engineering

Master's Degree in Life Science or Engineering

Tools

LEAN certification

Job description

Position Overview

Lead a high-impact team that keeps manufacturing running smoothly, safely, and on schedule. As Supervisor, Deviation, you'll oversee materials, training, and production scheduling teams to ensure compliant, reliable operations. If you're a people-focused leader who thrives in dynamic environments and enjoys building processes and teams from the ground up, this role is for you.

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

About Us

• We are a 24/7 manufacturing organization committed to operational excellence, safety, and compliance.
• This role sits within the Manufacturing function and reports to the Manager, Manufacturing Support.
• You'll supervise a team of professional and skilled support contributors (approximately 4-8 direct reports), partnering closely with manufacturing, quality, supply chain, and other functions.
• Our environment is project-driven and fast-paced, with opportunities to shape and scale best-in-class Good Manufacturing Practice (GMP) processes.

Responsibilities During the Project Phase

• Lead operational readiness initiatives to ensure GMP readiness:
  • Create or transfer business processes from an existing large-scale facility.
  • Stand up and lead the manufacturing support documentation and recipe-driven operations team.
• Provide oversight of commissioning activities for support functions and ensure alignment with GMP standards.
• Administer company policies affecting employees (e.g., time off, shift work, inclement weather).
• Complete administrative responsibilities (e.g., timecard approvals, time off approvals, expense reports).
• Perform other duties, as assigned.

In Operations

• Manage and develop direct reports across materials, training, and production scheduling support teams:
  • Provide coaching and guidance to foster growth and performance.
  • Address performance gaps and employee concerns; partner with HR as needed.
  • Participate in recruiting and retention to attract and retain talent, as needed.
• Oversee day-to-day support for manufacturing:
  • Coordinate campaign materials, Kanban, vendor-managed inventory support.
  • Oversee training curricula and readiness.
  • Manage detailed batch schedules and short flow investigations.
  • Monitor and maintain alert and action limits.
• Lead and manage change controls and corrective and preventive actions (CAPAs).
• Drive continuous improvement, elevate issues appropriately, and mitigate manufacturing risks.
• Support and act as a secondary lead for regulatory inspections and audits.
• Administer company policies impacting employees (e.g., time off, shift work, inclement weather).
• Complete administrative responsibilities (e.g., timecard approvals, time off approvals, expense reports).
• Perform other duties, as assigned.

Minimum Qualifications (Must-Haves)

• High School diploma/GED with 6 years related experience; or
• Bachelor's Degree in Life Science, Engineering, or related field with 2 years of related experience; or
• Master's Degree in Life Science, Engineering, or related field with no prior experience
• Experience directly supporting manufacturing
• Experience with regulatory inspections, investigations, and change management
• Experience in pharmaceutical or biological manufacturing operations
• Must be flexible to support a 24/7 manufacturing facility
• Ability to travel domestic and international up to 25% during project phase and operations

Preferred Qualifications

• Experience leading others in a pharmaceutical or biological manufacturing facility
• Experience working in a changing environment within a project-driven organization
• Lean certification or similar certifications

Knowledge, Skills, and Abilities

• Advanced understanding of GMPs, inspection readiness, safety, and manufacturing operations
• Strong collaboration skills with manufacturing and cross-functional stakeholders
• Excellent organizational skills and project management capabilities
• Proven ability to coach, lead, and develop individual contributors
• Strong presentation and communication skills
• Actively champions continuous improvement practices and ideas

Work Environment and Physical Requirements

• May require operating machinery/power tools; ability to move objects up to 10-33 lbs
• Ability to discern audible cues; ability to stand (up to ~30 minutes) and sit (up to ~60 minutes) for prolonged periods
• Work may occur in warm/cold environments and outdoors; no routine requirement for respiratory protection, hearing conservation program enrollment, or operating motor vehicles/PITs

Benefits

• Competitive pay with performance-aligned incentives
• Comprehensive health benefits (medical, dental, vision) and employee assistance resources
• Retirement savings plan with company support
• Paid time off, holidays, and leave programs
• Professional development and leadership training opportunities
• Inclusive culture that values safety, integrity, and continuous improvement
• Flexible support for a 24/7 operation, with resources to help balance work and life

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]).