Senior Director, Quality Employer ATCC Location Manassas, VA Start date Jul 26, 2026 View more categories View less categories Discipline Quality , Quality Control Required Education Bachelors Degree Position Type Full time Hotbed BioCapital Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Ready to shape the future of science and global health? 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. Responsibilities Quality Management System (QMS): 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.

Quality Assurance Across Operations:

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.

QC Laboratory Operations & Release:

Oversee QC laboratory operations, including method validation and release testing, ensuring consistent product disposition decisions and compliance with applicable standards.

Validation & Data Integrity:

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.

Supplier Quality & Regulatory Compliance:

Oversee supplier quality and external partner compliance, including partnership on the start-up of ATCC's new facility in Manassas.

Leadership & Culture:

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. Qualifications 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.

Preferred:

Experience supporting quality requirements and facility start-up operations.

Preferred:

PhD and/or educational background in biology or related life sciences field. Benefits We Invest in

You Health & Wellness:

Comprehensive medical coverage and company paid Life Insurance, Disability Insurance, AD&D, and paid parental leave Work life balance with Paid Holidays and PTO Fitness and cell phone subsidies, and additional benefits such as legal services, pet insurance and additional supplemental coverage. Employee Assistance Program offering around-the-clock counseling Financial security: 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans Exceptional career advancement opportunities, recognition, and rewards Corporate bonus program

Mission Focused:

Non-profit organization supporting critical life science research We give scientists the tools they need to make discoveries that improve and save lives Contribute to community involvement and social responsibility Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us. Company ATCC is a private, nonprofit, global biological resource center and standards organization. We provide the scientific community credible biological products, advanced model systems, and high-quality services that support complex research in a variety of innovative applications resulting in incredible achievements in basic science, drug discovery, translational medicine, and public health. We support the scientific community with the world's largest and most diverse collection of human and animal cell products, as well as molecular genomic tools, microbe products, and biological materials. We offer a host of services, as well, including cell and microbial culturing and authentication, development and production of controls and derivatives, proficiency testing, and biomaterial deposit services. Through our ATCC Federal Solutions initiative, we lend our expertise to federal agencies in areas that include global health and infectious diseases, biodefense, and noncommunicable diseases. We've developed a quality commitment, which includes ISO accreditations and standards, that has allowed ATCC to evolve from a traditional culture collection founded in 1925 to a biological resource center with an infrastructure that supports the future of life science and biotechnology. Our newly expanded headquarters and bioproduction facility is located in Manassas, Virginia, near Washington DC, and a recently renovated research and technology center of excellence in Gaithersburg, Maryland.

CONNECT Company info Website http:

//www.atcc.org/ Phone (703)365-2700 Location 10801 University Boulevard Manassas Virginia 20110 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Associate Director, GMP QA Operations Waltham, MA (Fixed-Term) Manufacturing Associate, Drug Substance - Shift Position Oxford - England Director of Operations Pennsville, NJ