Supervisor, QA Drug Product - Second Shift

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Supervisor, QA Drug Product provides day-to-day supervision and risk-based Quality Assurance (QA) support for Drug Product (DP) manufacturing operations and processes. The role is the primary point of contact for the QA Operations DP team and the first line of escalation within its areas of responsibility. It identifies operational gaps and improvement opportunities, partners with leadership to prioritize solutions, maintains relationships with site customers and global colleagues, and allocates resources for shop-floor, QA support, and technical QA activities. The supervisor leads cross-functional operational-readiness and new-product-introduction efforts using a risk-based approach, collaborates with Responsible Persons to support timely disposition of DP material, and serves as a subject matter expert during audits and inspections. The role establishes and maintains training goals, develops and coaches team members, and supports their professional growth. It also administers relevant company policies and routine administrative processes, participates in recruiting and retention efforts, and addresses performance matters in partnership with HR as needed. The position initially works second shift on a Monday–Friday, 3:00 p.m.–11:30 p.m. schedule and is eligible for shift differential under company policy. The role is expected to transition to a 2-2-3, 12-hour rotating schedule, with the assigned shift and timing subject to business needs and communicated in advance. This position supports 24/7 operations and may require nonstandard and rotating shifts, including nights, weekends, and holidays. Occasional domestic or international travel may be available. FUJIFILM Biotechnologies is developing a biopharmaceutical manufacturing facility in Holly Springs, North Carolina. The company describes a dynamic work environment and a culture called Genki. FUJIFILM is headquartered in Tokyo and has more than 70,000 employees across four business segments.

Requirements

Bachelor’s degree and 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 for partnering with teams and stakeholders.
Strong time-management skills and 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-oriented approach and ability to build relationships and communicate effectively.
Positive attitude and ability to work in a dynamic 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, in a 24/7 operations environment.
Ability to discern audible cues.
Ability to inspect or perform tasks with 20/20 corrected vision and visual acuity, including distinguishing color.
Ability to stand and sit for prolonged periods, up to 120 minutes.
Ability to perform repetitive motions involving wrists, hands, and/or fingers.
Ability to move objects weighing up to 10 pounds.
Ability to bend, push or pull, reach for materials from 18 to 60 inches in height, and use twisting motions.
Ability to work in warm or cold environments of 2–8°C.

Nice To Haves

Knowledge of Technology Transfer and/or Product Commercialization processes.
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 or understanding of hygienic utilities, quality systems, automation, manufacturing and IT systems, and production-equipment validation.
Understanding of Data Integrity and 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.
Identify recommendations and gaps in the area of responsibility 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 resources for shop-floor QA activities, including batch production record review, event triage, and AQL; QA support activities, including deviation/CAPA review and approval, clearance, and area release; and technical QA activities, including change-control review and approval and work-order oversight.
Lead cross-functional teams to achieve 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 support compliance with cGMPs and regulatory requirements.
Train, coach, mentor, and guide team members and peers, supporting professional development and increased responsibility where appropriate.
Work with team members to identify improvement areas and blind spots and align development opportunities with individual career objectives.
Administer company policies affecting employees, including time off, shift work, and inclement weather policies.
Complete administrative tasks such as timecard and time-off approvals and expense reports.
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.