Director, Quality Assurance

PROGRAM DESCRIPTION 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. KEY RESPONSIBILIBES 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 regulatory agencies. Direct investigations and resolution of potential product quality events, driving effective corrective and preventive actions (CAPA) and continuous improvement initiatives. Establish, implement, and maintain a phase-appropriate Quality Management System (QMS). Chair quarterly Quality Board Meetings with LBR and NCI BRB management. Evaluate existing quality systems, processes, metrics, and technical programs to identify opportunities for continuous improvement and operational efficiency. Provide strategic leadership, coaching, and mentorship to the quality team to support professional development and high performance. Recruit, develop, and evaluate personnel to ensure efficient and effective operation of the quality function. Serve as a collaborative cross-functional partner, providing sound quality and compliance guidance grounded in regulatory requirements, industry best practices, and business objectives. Build and maintain strong working relationships with internal stakeholders, external partners, clients, and regulatory representatives. Demonstrate strong negotiation, problem-solving, and decision-making skills, with the flexibility to deliver solution-oriented approaches to emerging challenges. Accountable for executing and administering quality systems pertaining to GMPs, relevant ICH, US and EU regulations. Provides leadership and direction to managers and QA staff and advises BDP staff in quality systems. Functional budget holder. Develops, adapts and executes functional or departmental strategy to achieve key business objectives in area of responsibility. Impact is on medium- to long-term functional goals. May directly impact the results of several functional areas. Decisions are guided by organization and functional strategies and objectives. Function manager with broad extensive knowledge of the theories and practices within a functional area and its interrelationship with other functional areas. Implementation of solutions often requires a longer-term view, conceptual thinking, devising and applying new concept and solutions, while taking into consideration multiple perspectives and future implications. Reconciles multiple stakeholder views, requiring awareness, respect, and the ability to reconcile cultural differences. BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, must have a minimum of ten (10) years of progressively responsible experience, including eight (8) years in a leadership/manager capacity. Extensive knowledge and experience in GxP and QA principles, practices, regulatory and industry standards. Experience with using risk-based principles and decision making to ensure compliance at all stages of development. Must possess basic Microsoft Office skills. Ability to obtain and maintain a security clearance. JOB HAZARDS This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.