Senior Director, Quality

ATCC•Manassas, VA

4d•$200,000 - $230,000•Onsite

About The Position

A global nonprofit that provides trusted biological materials for science and health, ATCC is hiring a Senior Director, Quality to provide enterprise leadership for ATCC’s Quality organization, ensuring compliance with applicable regulations and industry standards. Reporting to the Chief Operating Officer, this leader will oversee a team of up to 60 FTE across Quality Control, Quality Systems, Operations Quality, Validation, and External Supplier Quality, supporting regulated bioproduction of commercial catalog products and critical services for industry and government. ATCC is ISO 9001 and ISO 13485 certified and ISO/IEC 17025 and ISO 17034 accredited, with a mission-driven focus on excellence in quality. This is a highly visible leadership role responsible for advancing enterprise-wide quality performance, strengthening operational integration, and ensuring consistent quality and compliance across manufacturing and service delivery, in close partnership with internal and external stakeholders. This is an onsite position based fully in Manassas, VA or split between our Manassas, VA and Gaithersburg, MD facilities.

Requirements

Bachelor's degree and 18 or more years' experience, including 4+ years of supervisory experience, or equivalent combination of education and experience (PhD + 11 years or Masters + 16 years).
Progressive Quality leadership experience in ISO- or GMP-compliant organizations providing biologics products and services.
Demonstrated autonomy to lead a large, multi-functional Quality organization, drive enterprise-wide quality strategy, and partner with executive and operational stakeholders in a regulated manufacturing environment.
Expertise in ISO 13485, ISO 9001, ISO/IEC 17025, and ISO 17034, with strong command of quality systems expectations and audit execution. Proven track record of engaging external stakeholders as relevant for biologics quality operations.
Experience managing multi-functional Quality organizations spanning QMS, QC, validation, and supplier quality with measurable outcomes. Experience with oversight of multiple sites and R&D and manufacturing is a plus.
Demonstrated experience overseeing QC laboratory operations, method validation, and release testing for biological materials.
Strong capability in CAPA, deviation management, change control, risk management, controlled documentation, validation oversight (CSV/equipment/process), and data integrity.

Nice To Haves

Experience supporting quality requirements and facility start-up operations.
PhD and/or educational background in biology or related life sciences field.

Responsibilities

Provide strategic and scientific leadership for the organization’s risk-based QMS, ensuring compliant, controlled documentation and sustained inspection/audit readiness. Maintain and enhance core quality processes including CAPA, deviations, change control, and audits, consistent with applicable ISO standards and other relevant regulatory guidelines.
Lead and oversee Quality Assurance functions supporting BioProduction, ATCC Federal Services, Supply Chain, Facilities, and operational teams, embedding Quality within operations and facilities using a risk-based, science-based approach.
Oversee QC laboratory operations, including method validation and release testing, ensuring consistent product disposition decisions and compliance with applicable standards.
Provide oversight of validation programs (CSV, equipment, and process validation) and ensure data integrity principles are embedded across validated systems and processes in line with guidelines.
Oversee supplier quality and external partner compliance, including partnership on the start-up of ATCC's new facility in Manassas.
Build and lead high-performing teams, embedding a culture of quality through coaching, training, and cross-functional partnership across scientific and operational groups. Proactively partner with R&D, Operations, Supply Chain functions to continuously evaluate and optimize delivery of both Quality and on-time delivery of manufacturing and services.