Associate Director, QC Biological

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 7 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Associate Director QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross functional meeting focusing on both startup activities and routine operations. The leader will be responsible for hiring plans budget development strategic planning and driving results. This role plans schedules and oversees multiple QC laboratories in order to drive compliance goals schedule adherence profit plans and strategy objectives of the company and the department. The Associate Director QC Biological identifies operational needs for special projects (new product sub-team capital projects etc.)- ensuring site/divisional linkage is achieved. This role identifies and addresses short term intermediate and long-term issues in a satisfactory manner and appropriately resolves conflict and prioritizes work as necessary. The Associate Director QC Biological will be required to manage through levels including managers supervisors individual contributors etc.

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

Translates company goals into relevant department objectives focused on assuring the compliance supply profit plan strategy and people/culture objectives are appropriately implemented
Provides logistical and strategic support for achieving department objectives
Represents department for manufacturing customer and COE related activities as they relate to resource management
Assures laboratory is capable of delivering to proposed or scoped customer requirements
Assures adherence to headcount and budget plans
Initiates and drives implementation of technology and projects aimed at cost reduction efficiency improvements minimization of downtime and quality/safety enhancement. Fosters an environment for continuous improvement
Maintains state of inspectional readiness for department
Assures appropriate training requirements are established and that the staff maintains currency to the curricula
Assures team delivers on-time results with right first-time quality
Makes decisions on equipment selection qualification maintenance
Assures transferred methods align with department analytical platforms
Provides training and assurance that the transferred methods are fit for purpose and QC personnel are trained to perform the methods consistently
Assures Quality System requirements are delivered according to determined schedules
Fosters a safe working environment through appropriate training and engagement of QC staff
Assures policies practices standard work are consistent across the department
Conducts group communication meetings to facilitate project efficiency and/or distribute information
Develops and manages group against KPIs to assure alignment with objectives and manage to target
Participates in the development and management of capital and expense budget
Participates in and develops employee development plans to assure continuity to mid- and long-term succession plans
Manages and develops direct and indirect reports
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

Minimum Requirements:

Bachelors degree in Biology chemistry or related field with 11 years of relevant experience OR
MS degree with 9 years of relevant experience OR
Ph.D. with 7 years of relevant experience
4 years of people management and leadership experience
Experience working in a regulated GMP environment
Experience managing and developing direct reports and teams
Experience with QC Methods

Preferred Requirements:

8 years of experience working in a regulated GMP environment
Extensive experience with Drug Product production
Experience working in a contract manufacturing or testing organization
Experience with statistical experimental design and data analysis with JMP software
Experience with QC Microbiology methods Raw Material testing and contamination control

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 conduct activities using repetitive motions that include writs hands and/or fingers.

Ability to sit for prolonged periods of time up to 240 minutes.

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 environments

Will work in heights greater than 4 feet.

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:

Director

Position OverviewThe Associate Director QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross functional meeting focusing on both startup activities and routine operati...