Associate Director, Quality Control

About the Company

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. 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: healthcare, electronics, business innovation, and imaging.

About the Role

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.

Responsibilities

• 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.
• 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.
• 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.
• Coordinate and liaise with regulatory inspections, problem solving, failure mode and root cause analysis.
• 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.
• 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.
• 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.
• 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.

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.

Benefits

• Medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• Industry-leading 401(k) savings plan.
• Insurance coverage, employee assistance programs and various wellness incentives.
• Paid vacation time, sick time, and company holidays.
• Supportive environment that enriches both personal and professional growth.