Supervisor, QA Drug Product Second Shift

Position Overview

This position supports a Monday-Friday 3pm-11:30pm shift the future this will shift to a 2/2/3 6am-6pm or 6pm-6am schedule.

The QA Operations Shift Supervisor is responsible for providing day-to-day supervision and risk-based QA support of the Drug Product Manufacturing area and processes.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

• Provides day-to-day supervision of the Quality Assurance (QA) Operations Drug Product (DP) Team.
• Applies expertise in manufacturing QA concepts and business knowledge to act as primary point of contact for their team and first line escalation point in areas of their responsibility.
• Gathers recommendations for enhancements and gaps related to their area of responsibility and in collaboration with leadership prioritize and implement solutions accordingly.
• Maintains relationships with site-based customers and global colleagues and provide updates to leadership as requested.
• Ensures allocation of adequate resources for shop floor QA activities (e.g. BPR review event triage AQL) QA support activities (e.g. deviation/CAPA review and approval clearance and area release) and technical QA activities (e.g. Change Control review and approval WO oversight).
• Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based right-size approach.
• Collaborates with Responsible Person(s) to facilitate timely disposition of DP material.
• Serves as Subject Matter Expert (SME) in audits and inspections for DP area.
• Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
• Provides training coaching and mentorship of their team and peers as applicable. Works with their team to identify areas of improvement reduce blind spots and give opportunities for increasing responsibility as appropriate for each individuals career objectives.
• Administers company policies such as time off shift work and inclement weather that directly impact employees.
• Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.).
• Coaches and guides direct reports to foster professional development.
• Participates in the recruitment process and retention strategies to attract and retain talent as needed.
• Addresses performance gaps employee questions and concerns and partners with HR as needed for resolution.
• Other duties as assigned.

Knowledge Skills or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to adapt in a fast-paced environment pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills organization and planning skills.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Positive attitude to embrace a dynamic work environment.
• Knowledge of Technology Transfer and/or Product Commercialization processes.
• Occasional opportunity for International and/or Domestic travel may be available.
• Ability to coach lead and develop individual contributors.
• Ability to effectively present information to others.
• This role supports a 24/7 operations environment and requires working nonstandard and rotating shifts including nights weekends and holidays as assigned. Upon hire the position will be assigned to second shift on a 5x8 schedule and is eligible for shift differential in accordance with Company policy. The role is expected to transition to ahour rotating schedule with shift differential eligibility per policy. The timing of the transition will be communicated in advance and is subject to business needs.

Minimum Requirements:

• Bachelors degree with 4 years of experience from a similar role.
• 2 years of team management experience.
• Experience leading supervising or managing others.
• Experience working in a regulated GMP environment.

Preferred Requirements:

• 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 level of familiarity/understanding of 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.

Working Conditions & Physical Requirements:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.
• Ability to stand for prolonged periods of time up to 120 minutes.
• Ability to sit for prolonged periods of time up to 120 minutes.
• Ability to conduct activities using repetitive motions that include writs hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
• Will work in warm/cold environment 2-8 degrees C.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Manager