Supervisor, QA Drug Product - Second Shift

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The Supervisor, QA Drug Product provides day-to-day supervision and risk-based QA support for Drug Product Manufacturing. The role supervises the QA Operations Drug Product team, serves as a primary contact and first-line escalation point for its areas of responsibility, and works with leadership and cross-functional partners to identify and implement improvements. It ensures appropriate staffing and resource allocation for shop-floor, QA support, and technical QA activities; supports operational readiness and new product introduction; and works with Responsible Persons to facilitate timely disposition of Drug Product material. The supervisor serves as a subject matter expert during audits and inspections, maintains training goals and develops team members through training, coaching, and mentorship. The position also handles employee administration and performance matters, contributes to recruitment and retention, and supports a 24/7 manufacturing operation. The position is initially assigned to a Monday–Friday, 3:00 p.m.–11:30 p.m. second-shift schedule, with shift differential eligibility under company policy. It is expected to transition to a 2-2-3, 12-hour rotating schedule; the eventual shift may be 6:00 a.m.–6:00 p.m. or 6:00 p.m.–6:00 a.m. The role requires nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. The timing of the transition will be communicated in advance and is subject to business needs. Occasional domestic or international travel may be available. The role is based at FUJIFILM Biotechnologies’ Holly Springs, North Carolina facility. Work may include warm or cold environments of 2–8°C and requires the physical capabilities described in the posting.

Requirements

Bachelor’s degree and 4 or more years of experience in a similar role.
At least 2 years of team management experience.
Experience leading, supervising, or managing others.
Experience working in a regulated GMP environment.
Strong verbal and written communication skills for partnering with teams and stakeholders.
Strong time management and ability to meet tight deadlines and prioritize tasks effectively.
Ability to adapt and adjust plans in a fast-paced environment.
Critical thinking, problem-solving, organization, and planning skills.
Collaborative attitude and ability to build relationships and communicate effectively.
Ability to coach, lead, and develop individual contributors.
Ability to present information effectively.
Ability to work nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned.
Ability to discern audible cues; perform inspection or tasks with 20/20 corrected vision and distinguish color; stand and sit for up to 120 minutes; perform repetitive motions involving wrists, hands, or fingers; move objects up to 10 pounds; and bend, push, pull, reach between 18 and 60 inches, and twist.

Nice To Haves

Understanding of formulation, aseptic filling, and/or visual inspection.
Working knowledge or experience with Trackwise, Veeva, PAS-X, Smartsheet, and/or Kneat.
Experience with startup projects.
High familiarity with 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.
Knowledge of technology transfer and/or product commercialization processes.

Responsibilities

Provide day-to-day supervision of the QA Operations Drug Product team and risk-based QA support for Drug Product Manufacturing.
Serve as the primary contact and first-line escalation point for the team’s areas of responsibility.
Gather recommendations about enhancements and gaps, and work with leadership to prioritize and implement solutions.
Maintain relationships with site-based customers and global colleagues, and provide updates to leadership as requested.
Ensure adequate resource allocation for shop-floor QA activities, QA support activities, and technical QA activities.
Lead cross-functional teams in operational readiness and new product introduction using a risk-based, right-size approach.
Collaborate with Responsible Persons to facilitate timely disposition of Drug Product material.
Serve as a subject matter expert during audits and inspections for the Drug Product area.
Establish and maintain internal and external training goals for self and team to support cGMP and regulatory compliance.
Train, coach, and mentor team members and peers; identify improvement opportunities and support employees’ development and career objectives.
Administer company policies affecting employees, including time off, shift work, and inclement weather.
Complete administrative tasks such as timecard and time-off approvals and expense reports.
Coach and guide direct reports to foster professional development.
Participate in recruitment and retention strategies as needed.
Address performance gaps and employee questions or concerns, partnering with HR as needed.
Perform other duties as assigned.