Associate Director, Quality Control

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, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s 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, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s 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 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do: 

 

Strategy & Governance

• Define and execute QC strategy, annual goals, and budget aligned to business and regulatory requirements in collaboration with theHead of QC.
• Direct and maintain QC quality system elements (e.g., OOS/OOT, deviations/CAPA, change control, data integrity, methodvalidation/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.
• Demonstrat