Senior Director, Quality (Biologics)

Location: Onsite in Manassas, Virginia, or split between the Manassas, VA and Gaithersburg, MD facilities

Company

ATCC is a global nonprofit providing biological materials and critical services for scientific research, public health, industry, and government.

What you will do

• Provide enterprise leadership for the risk-based Quality Management System, including CAPA, deviations, change control, controlled documentation, audits, and inspection readiness.
• Lead Quality Assurance support for BioProduction, Federal Services, Supply Chain, Facilities, and operational functions.
• Oversee QC laboratory operations, method validation, release testing, and product disposition decisions.
• Direct CSV, equipment, and process validation programs while embedding data integrity across validated systems.
• Oversee supplier quality and external partner compliance, including quality support for a new Manassas facility.
• Lead a multifunctional Quality organization of up to 60 FTE and build a cross-functional culture of quality.

Requirements

• Bachelor’s degree with 18 years of experience, or equivalent experience; alternative combinations include a master’s degree with 16 years, a PhD with 11 years, or a high school diploma with 22 years.
• Progressive Quality leadership experience in ISO- or GMP-compliant organizations producing biologics.
• Experience leading large, multifunctional Quality organizations across QMS, QC, validation, and supplier quality.
• Expertise in ISO 13485, ISO 9001, ISO/IEC 17025, and ISO 17034, including quality systems and audit execution.
• Experience overseeing QC laboratory operations, method validation, release testing, CAPA, deviations, change control, risk management, and data integrity.
• Ability to work onsite in Manassas, VA, or across the Manassas and Gaithersburg facilities.

Nice to have

• Experience supporting facility start-up and quality requirements.
• Experience overseeing multiple sites, R&D, and manufacturing operations.
• PhD or an educational background in biology or a related life sciences field.

Culture & Benefits

• Mission-focused nonprofit supporting life science research and global public health.
• Medical coverage, company-paid life and disability insurance, AD&D, and paid parental leave.
• Paid holidays, PTO, fitness and cell phone subsidies, and an employee assistance program.
• 401(a) retirement contribution, 403(b) matching, corporate bonus program, and career advancement opportunities.
• Additional benefits include legal services, pet insurance, supplemental coverage, recognition, and community involvement opportunities.