Associate Manager, QA DSM Operations

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Associate Manager QA Operations leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced dynamic environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role collaborates with leadership site-based customers and global colleagues.

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 supervision of the QA Operations DSM Upstream team. Ensures allocation of adequate resources for shop floor QA activities (e.g. BPR review event triage) QA support activities (e.g. DR/CAPA review and approval changeover and area release) and technical QA activities (e.g. CC 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 DS material
Serves as Subject Matter Expert in audits and inspections for their area of responsibility
Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
Identifies and leads process optimization initiatives and continuous improvement tasks in their area of responsibility
Applies expertise in manufacturing QA concepts and business knowledge to act as the primary point of contact for their team and the first-line escalation point in areas of their responsibility
Gathers recommendations for enhancements and gaps related to their areas of responsibility and in collaboration with leadership prioritizes and implements solutions accordingly
Establishes a QC Sample Control laboratory including but not limited to: SOP creation training plan for team inventory management delivery of operational and inspection readiness goals leading in both a project and routine operations environment
Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested
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:

BS in Life Sciences or Engineering and minimum 5 years of relevant experience OR
MS in Life Sciences or Engineering and minimum 3 years of relevant experience OR
Ph.D. in Life Sciences or Engineering and minimum 1 years of relevant experience
2-4 years of people management experience
Experience working in a regulated GMP environment

Preferred Requirements:

Experience and working knowledge of ASTM E2500 Smartsheet Trackwise MasterControl and/or Kneat validation software is a plus
Experience and understanding of the following processes preferred such as cell culture or fermentation
Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills
Training and/or familiarity with Quality Risk Management principles preferred

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders scaffolding ramps etc. No x Yes
Ability to stand for prolonged periods of time. No x Yes Daily for up to 60 minutes (If yes may specify frequency/duration: up to
minutes)
Ability to sit for prolonged periods of time. No x Yes Daily for up to 60 minutes (If yes may specify frequency/duration: up to
minutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No x Yes
Ability to operate machinery and/or power tools. x No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes x 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. x No Yes

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 Associate Manager QA Operations leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced dynamic environment. This role is the primary point of contact for their...