Manager, Compliance & Support, Drug Product

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Manager of Compliance & Support DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps authoring departmental standard operating procedures (SOPs) creating master batch records in electronic systems managing the production scheduler batch record reviewers manufacturing execution systems associates and training coordinators. The role also supports shop floor activities for deviations corrective and preventive actions (CAPAs) and aids in materials management for production operations.

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

Builds and manages the Manufacturing Support team
Supervises the Manufacturing Support team and establish individual and team goals
Oversees and coordinates team tasks including managing the production scheduler
Fosters an inclusive culture with development plans and regular meetings
Coaches and supports team members for professional growth
Acts as lead for regulatory inspections and audits
Coordinates non-batch activities own change controls and manage Corrective Actions Preventative Actions within Trackwise
Leads continuous improvement initiatives
Manages batch record review and cycle time Key Performance Indicators
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
Performs other duties as assigned

Basic Requirements

High School Diploma or GED with 11 years of experience from a similar role in large pharma/biotech operations or projects OR
Associate degree in Pharmaceutical Sciences Life Sciences or a related field with 9 years of direct experience OR
Bachelors degree in Pharmaceutical Sciences Life Sciences or related field with 7 years of direct drug product manufacturing experience OR
Equivalent military experience or training
Up to 2 years of people management experience
Experience working in a regulated GMP environment

Preferred Requirements

2-5 years of people management experience
Experience in aseptic drug product manufacturing cross-functional collaboration sterile processing or quality assurance

Bioworks or BTEC Coursework

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
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers
Ability to conduct work that includes moving objects up to 10 pounds

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

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

Position OverviewThe Manager of Compliance & Support DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps authoring departmental standard operating procedures (SOPs) creating master batch records in ele...