Supervisor, QA Drug Product - Second Shift

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The QA Operations Shift Supervisor provides day-to-day supervision and risk-based Quality Assurance support for Drug Product (DP) manufacturing areas and processes. The supervisor serves as the team's primary contact and first-line escalation point, coordinates QA resources across shop-floor, support, and technical activities, and works with site customers, global colleagues, leadership, and Responsible Persons to support operations and timely disposition of DP material. The role leads cross-functional operational-readiness and new-product-introduction efforts, serves as a subject matter expert during DP audits and inspections, and maintains training and compliance goals for the team. It also includes coaching and developing employees, supporting recruitment and retention, administering company policies and routine employee administration, and partnering with HR to address performance or employee concerns. The position initially works a Monday–Friday, 3:00 p.m.–11:30 p.m. schedule and is expected to transition to a 2-2-3 rotating 12-hour schedule, either 6:00 a.m.–6:00 p.m. or 6:00 p.m.–6:00 a.m. The role supports 24/7 operations and may require nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Shift differential eligibility is subject to company policy. Occasional domestic or international travel may be available.

Requirements

Bachelor's degree.
At least 4 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 and the ability to work with different teams and stakeholders.
Strong time management and the ability to prioritize tasks and meet tight deadlines.
Ability to adapt and adjust plans in a fast-paced environment.
Critical thinking, problem-solving, organization, and planning skills.
Team-based attitude and ability to build relationships and communicate effectively.
Positive attitude and ability to embrace a dynamic work environment.
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.
Ability to inspect or perform tasks with 20/20 corrected vision, including visual acuity and distinguishing colors.
Ability to stand and sit for prolonged periods, up to 120 minutes.
Ability to perform repetitive motions involving the wrists, hands, and/or fingers.
Ability to move objects weighing up to 10 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
Ability to work in warm or cold environments of 2–8 degrees C.

Nice To Haves

Knowledge of Technology Transfer and/or Product Commercialization processes.
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 familiarity with or understanding of hygienic utilities, quality systems, automation, manufacturing and IT systems, and production-equipment validation.
Understanding of Data Integrity and the application of 21 CFR Part 820 and Part 11.
Occasional domestic and/or international travel may be available.

Responsibilities

Provide day-to-day supervision of the QA Operations Drug Product team and serve as its primary point of contact and first-line escalation point.
Gather recommendations for enhancements and identify gaps within areas of responsibility; collaborate 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 resources are allocated for shop-floor QA activities, QA support activities, and technical QA activities.
Lead cross-functional teams in achieving operational-readiness objectives and new-product-introduction goals 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 for Drug Product audits and inspections.
Establish and maintain internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
Train, coach, and mentor team members and peers as applicable, and guide direct reports' professional development.
Work with the team to identify improvement areas, reduce blind spots, and provide opportunities for increased responsibility aligned with individual career objectives.
Administer company policies affecting employees, including time off, shift work, and inclement weather.
Complete administrative tasks such as timecard approvals, time-off approvals, and expense reports.
Participate in recruitment and retention activities as needed.
Address performance gaps and employee questions or concerns, partnering with HR as needed.
Perform other duties as assigned.