Senior Director, Quality

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.