Manager, All QC

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Manager All-QC team is responsible for contributing to key functional tactical and operational aspects of the QC group and will lead the 223-shift teams that are responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples clean utility environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all the QC laboratories required for urgent testing/Manufacturing support. This role will direct the scheduling across all shifts initiation of process improvements serve as a liaison across all QC teams modeling the leadership competencies aiding in the development of peers and performing QC approvals as required.

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

Ensures and owns GMP-compliant laboratory operations in alignment with EU GMP 21 CFR Partsand other applicable GMP guidelines.
Provides cross-functional leadership and mentorship as the QC laboratory representative.
Directs four shift supervisors to ensure 24/7 QC team coverage.
Oversees supervision and scheduling across 223 shifts for the All-QC laboratory team.
Applies expertise in laboratory methodology and compendial requirements for QC testing that span all the QC labs (e.g. Bioburden Endotoxin HPLC UV280 TOC etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
Acts as primary point of contact for their team and first line escalation point in areas of their responsibility.
Coordinates the review of analytical data to support test validation qualification and certification activities. Performs investigations manages complex issues barriers and problems to support team success. Approve data reports within the team and area of discipline/focus including approval of results
Authors protocols change control requests and Quality Technical Reports for ensuring successful execution of qualification analytical improvement projects in collaboration with cross-functional teams as appropriate
Provides technical leadership through effective project management status tracking presentations and communication
Proactively identifies technical gaps and areas for improvement related to quality. Process and lead internal and external audits proficiently including commitments on follow up within team & site management serves as External Leadership cross-functionally.
Represents QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders
Provides regular guidance to direct reports; fosters a positive collaborative work environment that prioritizes team success; mentors junior staff in quality systems and continuous process improvement.
Establishes clear requirements deliverables measurable goals and targets and mitigation plans aligned with quality directives regulatory guidance and business priorities.
Ensures timely and appropriate mitigation of issues and deviations.
Manages complex problem solving providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods results product and/or Quality systems decisions with impact to customers or pertaining to personnel issues that must be handled with consultation and recommendations to management. Supports key business strategies
Conducts approval of complex reports data of others; Leads complex problem solving through facilitation/escalation. Conducts impact assessment related to compliance (e.g. global directives audit finding/readiness deviations).
Provides technical support during audits/inspections
Ensures adherence to all regulatory licenses and regulations serving as a subject matter expert in multiple disciplines interfacing with key customers
Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.)
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

Minimum Requirements:

Bachelors degree in chemistry Microbiology Biological Sciences Engineering or related science with 4 years of related experience OR
Masters degree in chemistry Microbiology Biological Sciences Engineering or related science with 2 years of related experience
Degree with emphasis in life science or engineering preferred
4 years experience managing people
Experience working in a changing project driven organization
Previous experience directly supporting function
Experience with regulatory inspections investigations and change management preferred
Experience in pharmaceutical / biological manufacturing operations preferred
Experience leading others in a pharmaceutical/biological manufacturing facility preferred

Preferred Requirements:

5 years of experience in a GMP environment

Physical and Work Environment 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 240 minutes)
Ability to sit for prolonged periods of time (up to 240 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 33 pounds.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.

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 All-QC team is responsible for contributing to key functional tactical and operational aspects of the QC group and will lead the 223-shift teams that are responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples clean util...