QA Drug Product Operations Lead (2-2-3 Shift)

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Operations Shift Supervisor to oversee Drug Product QA activities on the 3pm-11:30pm shift, with future 6am-6pm/6pm-6am 2-2-3 alternating schedule. You will supervise the DP QA team, ensure compliance with cGMPs, and coordinate with cross-functional teams to support product manufacturing.

This role emphasizes risk-based decision making, training, and developing staff, with opportunities to participate in audits and regulatory interactions.

Qualifications

• Bachelor's degree in a relevant field with 4+ years of experience in QA or manufacturing.
• Experience in regulated GMP environments is required.
• Strong knowledge of quality systems and regulatory concepts.

Responsibilities

• Provides day-to-day supervision of the QA Operations DP team.
• Acts as primary contact and first-line escalation point.
• Prioritizes and implements improvements with leadership.
• Maintains relationships with site customers and global colleagues.
• Ensures resources for QA activities (reviews, event triage, AQL).
• Leads cross-functional teams to achieve readiness and NPI goals.
• Collaborates with Responsible Persons for timely DP material disposition.
• Serves as SME in audits and inspections for the DP area.

Skills

Verbal & Written Communication

Time Management

Adaptability

Critical Thinking

Team Leadership

Positive Attitude

Regulatory Knowledge

Education

Bachelor's degree in a related field

Tools

Trackwise

Veeva

PAS-X

Smartsheet

Kneat

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Operations Shift Supervisor to oversee Drug Product QA activities on the 3pm-11:30pm shift, with future 6am-6pm/6pm-6am 2-2-3 alternating schedule. You will supervise the DP QA team, ensure compliance with cGMPs, and coordinate with cross-functional teams to support product manufacturing.

This role emphasizes risk-based decision making, training, and developing staff, with opportunities to participate in audits and regulatory interactions.