Associate Manager, QC Raw Materials

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Associate Manager leads a subsection of the Global QC Raw Material group ensuring that day-to-day tasks are carried out efficiently in relation to raw material activities for tech transfers and material lifecycle management. This involves coordinating the teams workload developing team members through targeted training and performance evaluations and driving projects and cross-site collaboration. The function also includes tracking team progress promoting innovation and ensuring alignment with departmental milestones as well as global QC milestones. Through effective communication resource management and strategic oversight the Associate Manager fosters overall quality compliance and continuous improvement within the organization.

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

Coordinates day-to-day activities scheduling and resource allocation balancing the QC Raw materials teams workload against established priorities and management milestones (e.g. report/data approval schedules quality systems).
Implements best industry practices identifies areas for improvement and continuously seeks to enhance operational quality and efficiency in close collaboration with the remainder of the Global QC Raw Material leadership team.
Authors and reviews procedures documents and reports to support QC Raw Materials operations and tech transfer activities; routes for approval per quality systems.
Maintains GMP-compliant operations by adhering to procedures global directives and quality systems; ensures inspection readiness and complete accurate documentation.
Represents the team both within and outside the organization facilitating clear communication and fostering collaborative relationships.
Optimizes team performance by systematically tracking workload successes and challenges and by recommending improvements to support overall departmental efficiency.
Supports tech transfer projects by coordinating materials readiness data collection and actively engaging in customer communications.
Collaborates cross-functionally with QC Analytical Development QC Program Management Manufacturing Process Science Supply chain and Quality Assurance to meet program deliverables.
Execute first-line people leadership tasks per company policies including on-the-job coaching feedback and day-to-day guidance of team members.
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.).
Performs other duties as assigned.

Knowledge Kills or Abilities

Displays and advanced knowledge of regulatory requirements for materials (e.g. cGMPs USP EP JP and ICH)
Possesses a broad knowledge of quality control operations systems and directives.
Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
Demonstrates excellent leadership and people management skills.
Demonstrates excellent technical writing skills and clear oral and written presentation abilities.
Ability to make clear and informed decisions with limited information based on previous experience with analytical transfers.
Strong stakeholder management and communication skills enabling alignment across sites and global functions.
Displays strong organizational skills with an ability to multi-task and coordinate multiple activities in parallel.
Able to work effectively independently and within a team framework across all business areas and levels of the organization.
Ability to coach lead and develop individual contributors.

Minimum Qualifications

Bachelors degree in Life Sciences or Engineering and 6 years of experience in GMP quality assurance and/or similar role OR
Masters degree in Life Sciences or Engineering and 4 years of experience in GMP quality assurance and/or similar role.
5 years of experience within pharmaceutical industry preferably within the field of starting materials.
Prior leadership experience.

Preferred Qualifications

2 years of direct supervisory experience.
5 years of experience in a GMP environment.
Experience with Microsoft Office Smartsheet LIMS and ERP systems (e.g. SAP).

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job the employee is required on a regular basis to:

May work in Mechanical/Production spaces that may require hearing protection and enrollment in hearing conservation program.
Ability to stand for prolonged periods up to 60 minutes.
Ability to sit for prolonged periods up to 30 minutes.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.

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.

*LI-Onsite

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 Associate Manager leads a subsection of the Global QC Raw Material group ensuring that day-to-day tasks are carried out efficiently in relation to raw material activities for tech transfers and material lifecycle management. This involves coordinating the teams workload developi...