Associate Director, Quality Control

Fujifilm

Job Location:

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Associate Director Quality Control leads the QC strategy systems and operations to ensure product quality compliance and release readiness. This role oversees analytical method lifecycle management laboratory operations stability and reference standards programs data integrity and QC digital systems and external testing partners. The AD provides technical and people leadership drives continuous improvement and partners closely with QA Manufacturing/Operations Supply Chain R&D and Regulatory to meet business regulatory and customer requirements.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

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:

Strategy & Governance

Define and execute QC strategy annual goals and budget aligned to business and regulatory requirements in collaboration with the
Head of QC.
Direct and maintain QC quality system elements (e.g. OOS/OOT deviations/CAPA change control data integrity method
validation/transfer).
Establish and maintain QC policies SOPs and training curricula in collaboration with the Head of QC.

Operational Leadership

Lead day-to-day QC operations across in-house and contract labs; ensure on-time testing release and stability commitments.
Oversee analytical method development/verification/validation and method lifecycle management.
Ensure robust sampling plans specifications and statistical approaches to trend analysis and control.
Manage supplier/CMO/CRO testing strategies quality agreements audits and performance.
Compliance and Data Integrity
Ensure compliance with applicable regulations and standards (e.g. GMP GLP ISO 9001/13485 ICH Q series) and internal QMS.
Champion data integrity (ALCOA) and secure validated QC digital systems (e.g. LIMS CDS ELN).
Lead and support inspections/audits; drive sustainable CAPA effectiveness
Management and coordination of manufacturing schedules and QC personnel support
Proven collaboration with manufacturing supply chain regulatory materials management
Coordinate and liaise with regulatory inspections
Problem solving failure mode and root cause analysis

People & Organization

Build coach and retain a high-performing team; oversee Leads Supervisors /senior SMEs.
Workforce planning capability development and succession planning for critical roles.
Foster a culture of safety quality inclusion and continuous improvement.
Continuous Improvement and Technology
Drive Lean/Six Sigma initiatives to improve cycle time right-first-time and cost.
Evaluate and implement advanced analytics PAT automation/robotics and digital lab solutions.

Cross-Functional Collaboration

Partner with QA for release/approval decisions and quality risk management.
Collaborate with Manufacturing/Operations for deviation investigations and process control.
Support Regulatory submissions responses and product lifecycle changes requiring QC input.

Metrics & Reporting

Own QC KPIs (e.g. on-time release OOS rate lab investigation cycle time CAPA effectiveness stability adherence cost per test).
Provide regular performance reports and risk updates to leadership.

Minimum Requirements:

Bachelor of Science in Microbiology or related technical field and 10 years of experience in QC/analytical in a regulated environment with 3 years of leading teams and/or managers.
Demonstrated expertise with GMP/GLP/ISO standards and regulatory expectations; successful audit/inspection history.
Proven track record in method validation/transfer stability programs and data integrity.
Experience implementing or managing LIMS/CDS and validated computerized systems. Knowledge and experience of Bioburden endotoxin and EM testing.
Good Laboratory Practices (GLP) GMP or quality control training.

Preferred Qualifications:

Advanced degree (MS/PhD) and/or professional certifications
(e.g. ASQ Six Sigma).
Experience managing external testing partners and complex
global supply networks.
Background in one or more: small molecules biologics medical
devices/IVD or advanced therapies (cell/gene).
Familiarity with Quality by Design (QbD) risk management (ICH
Q9) and statistical/DoE tools.
BioWork Process Technician or Quality certification.

Working Conditions & Physical Requirements:

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to stand for prolonged periods of time - 60 minutes.
Ability to sit for prolonged periods of time - 60 minutes.
Ability to conduct activities using repetitive motions that include wrists 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.
Will work in warm/cold environments - 2-8 degrees C.

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 Quality Control leads the QC strategy systems and operations to ensure product quality compliance and release readiness. This role oversees analytical method lifecycle management laboratory operations stability and reference standards programs data integrity a...