Director, Quality Assurance

Director, Quality Assurance

Job . Employee Type: exempt full-time. Division:
Biopharmaceutical Development Program. Facility:
Frederick: ATRF.

Location:

8560 Progress Dr, Frederick, MD 21701 USA.

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel biologic agents for first-in-human clinical studies. BDP provides expertise and resources spanning early product development, process development, analytical characterization, cGMP manufacturing, and technology transfer to advance investigational therapies for cancer, rare diseases, HIV/AIDS, and other infectious diseases through Phase 1 and 2 clinical trials in collaboration with government, academic, and industry partners.

The Director, Quality Assurance, supports the Director of the Clinical Research Directorate in the management, oversight, and continuous improvement of the Quality Program for the Biopharmaceutical Development Program (BDP) at the National Cancer Institute (NCI). This role serves as a key liaison between the NCI’s Biological Resources Branch (BRB) and Leidos Biomedical Research, Inc., ensuring alignment of quality systems, regulatory compliance, and operational objectives.

The Director, Quality Assurance, provides leadership and oversight for quality assurance personnel and functions, including document control, auditing, regulatory affairs, and quality engineering activities such as facility validation and equipment calibration, to maintain Good Manufacturing Practice (GMP)-compliant facilities. Responsibilities include ensuring compliance with GMP and Good Laboratory Practice (GLP) regulations through oversight of change control, nonconformance management, internal and external audits, third-party audit hosting, GMP training, batch record review and lot release, documentation and label control, validation programs, equipment calibration, specification development, and product manufacturing support activities.

The Director, Quality Assurance, is also responsible for supporting Investigational New Drug (IND) Chemistry, Manufacturing, and Controls (CMC) section development for BDP clinical projects for FDA submission, including overall CMC submission life-cycle management. Additional responsibilities include managing departmental budgets and project activities; reviewing contractual Statements of Work (SOWs) and recommending quality management requirements; and collaborating with Project Leads to monitor project deliverables, timelines, and technical data to ensure product quality objectives are consistently achieved.

This role chairs quarterly meetings with the NCI to monitor Quality for the BDP and participates in meetings with NCI to support the development, execution, and tracking of project milestones. The position also provides direct supervision of subordinate staff and may require periodic travel to audit contract manufacturing and testing organizations or to qualify suppliers.

• Lead the development, implementation, and maintenance of quality assurance systems and regulatory affairs programs to ensure organizational compliance and operational excellence.
• Provide overall quality and compliance oversight for GMP manufacturing operations and supply chain activities.
• Direct and oversee day-to-day quality operations, including management of consultants, external auditors, and internal quality functions such as:
  • Internal auditing and document review activities
  • Training and compliance programs
  • Document control
  • Lot release activities
  • Regulatory affairs
  • Facility and equipment validation and calibration
  • Continuous improvement initiatives
• Ensure appropriate quality oversight of external vendors and suppliers, including Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs).
• Maintain in-depth knowledge of investigational clinical trial concepts and practices, including regulatory requirements and guidelines governing preclinical and clinical research, with specialized expertise in product development and GMP biologic manufacturing to meet U.S. FDA expectations.
• Ensure accurate preparation and submission of Regulatory Affairs documentation, including IND CMC sections, Pre-IND CMC documentation, CMC amendments, and responses to regulatory inquiries. Provide oversight to maintain BDP’s Facility Master File with the FDA.
• Manage and coordinate third-party audits conducted by NIH, clients, and…