Senior Director, Quality

Initial Therapeutics, Inc.; Manassas (VA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Comprehensive medical coverage

401(a) retirement plan

Corporate bonus program

Paid parental leave

Job summary

ATCC is seeking a Senior Director, Quality to lead their Quality organization, ensuring compliance with regulations. This role supports Quality Control and Assurance within operations and oversees a team of up to 60 FTE in Manassas, VA. The candidate should have 18+ years experience in biologics, with a strong command of ISO standards.

The position offers numerous benefits, including comprehensive medical coverage, retirement plans with employer contribution, and a commitment to public health.

Qualifications

• 18+ years of experience in biologics with 4+ years in supervisory roles.
• Experience in ISO- or GMP-compliant organizations.
• Proven autonomy in leading multi-functional Quality organizations.
• Expert in ISO standards related to quality.

Responsibilities

• Provide leadership for risk-based Quality Management System.
• Oversee Quality Assurance for BioProduction and operational teams.
• Manage QC laboratory operations and ensure compliance.
• Oversee supplier quality and external partner compliance.

Skills

Quality leadership

ISO standards compliance

Risk management

Data integrity

Capacity management

Education

Bachelor's degree

PhD in biology or related field

Tools

Quality Management System (QMS)

CAPA management

Validation techniques

Job description

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

• 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.