QA Drug Product Operations Lead - 2nd Shift

FUJIFILM; Holly Springs (NC); On-site; USD 95,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a QA Operations Shift Supervisor to lead the Drug Product (DP) QA team. The role focuses on day-to-day supervision, risk-based QA support, and ensuring compliance with cGMPs and regulatory requirements.

The position includes future shift changes to a 2-2-3, 12-hour rotating schedule with shift differential. The candidate will manage resources, coordinate with cross-functional teams, participate in audits, and drive training and professional

Qualifications

• Bachelor’s degree and 4+ years in a similar role.
• 2+ years of team management experience.
• Experience in a regulated GMP environment.

Responsibilities

• Provide day-to-day supervision of the QA Operations Drug Product team.
• Act as primary point of contact and first-line escalation for their area.
• Prioritize and implement improvements with leadership.
• Manage resources for QA activities on the shop floor.
• Lead cross-functional teams to achieve readiness and new product introduction goals.
• Serve as SME in audits and inspections for the DP area.
• Oversee training goals and coaching for the team.

Skills

Leadership

Communication

Problem-solving

Time management

Adaptability

Mentoring

Coaching

Education

Bachelor’s degree

Tools

Trackwise

Veeva

PAS-X

Smartsheet

Kneat

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a QA Operations Shift Supervisor to lead the Drug Product (DP) QA team. The role focuses on day-to-day supervision, risk-based QA support, and ensuring compliance with cGMPs and regulatory requirements.

The position includes future shift changes to a 2-2-3, 12-hour rotating schedule with shift differential. The candidate will manage resources, coordinate with cross-functional teams, participate in audits, and drive training and professional