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Quality Assurance Manager II, CGR (Cancer Genomics Research Laboratory)
Job ID: req4586
Employee Type: exempt full-time
Division: Clinical Research Directorate
Facility: Rockville: 9615 MedCtrDr
Location: 9615 Medical Center Drive, Rockville, MD 20850 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.
PROGRAM DESCRIPTION
The Cancer Genomics Research Laboratory (CGR) investigates the contribution of germline and somatic genetic variation to cancer susceptibility and outcomes in support of the NCI's Division of Cancer Epidemiology and Genetics (DCEG), the world's most comprehensive cancer epidemiology research group. Working in concert with epidemiologists, biostatisticians, and basic research scientists in DCEG's intramural research program, CGR provides the capacity to conduct genome-wide discovery studies and targeted regional approaches to identify the heritable determinants of various forms of cancer. The laboratory provides end-to-end research support, from study design and biospecimen processing, laboratory assay development and processing, and bioinformatics support for data analysis.
We are seeking a Quality Assurance Manager II to lead, maintain, and continuously improve the CGR quality management program in support of a large, complex laboratory operation of more than 100 staff. This position offers an exciting opportunity for an experienced laboratory quality professional to oversee quality assurance activities across diverse functional groups and teams performing high-throughput genomics and biospecimen-related work in support of critical cancer epidemiology and translational research efforts.
The incumbent will administer a mature and robust quality management system that supports document control, records management, staff training and competency, inventory and equipment management, safety, waste disposal, and other core laboratory support functions. This individual will work closely with laboratory leadership, operational managers, scientific staff, and quality personnel to ensure that CGR quality systems remain effective, scalable, and aligned with the needs of a high-performing research organization. This is an ideal opportunity for a candidate with demonstrated management experience in a laboratory environment, strong quality systems expertise, and the ability to lead and influence across multiple teams and functions.
KEY ROLES/RESPONSIBILITIES
The Cancer Genomics Research (CGR) laboratory is a fast-paced, high-throughput organization that supports histology, molecular and digital pathology, biological specimen processing and aliquoting, nucleic acid extraction, sample staging, genotyping, sequencing, and analysis for genetic and epidemiologic studies for investigators within DCEG. As a Quality Assurance Manager II, the incumbent will be responsible for overseeing and advancing quality systems across the organization. The incumbent is expected to report to the work site(s).
Core responsibilities include:

• Lead, administer, maintain, and improve the CGR quality management program across a large laboratory organization of over 100 staff
• Foster a culture of quality, compliance, and accountability
• Provide direct supervision, mentorship, and performance management for local and remote quality assurance specialists
• Partner with CGR leadership, laboratory managers, and functional teams to ensure quality systems support diverse laboratory workflows and operational needs
• Maintain and continuously improve the CGR document control system, ensuring effective management, review, approval, revision, distribution, and archival of standard operating procedures, forms, templates, and related controlled documents
• Oversee training program administration in collaboration with laboratory and operational leadership, including assignment of training roles, tracking completion of training, competency assessment approaches, and training records management
• Support and monitor programs related to laboratory inventory, reagents, materials, equipment management, preventive maintenance, calibration, and associated records
• Oversee quality-related aspects of laboratory support activities, including safety practices, waste management, and related documentation, in collaboration with laboratory management and support teams
• Lead internal audit and quality observation activities, including planning, execution, reporting, follow-up, and verification of remediation actions
• Maintain and improve processes for deviation management, nonconformance handling, corrective and preventive actions (CAPA), root cause analysis, and risk identification
• Monitor laboratory quality trends, metrics, and records to identify gaps, recurring issues, risks, and opportunities for standardization, harmonization, and continuous improvement
• Work seamlessly across functional groups and teams performing diverse scientific and operational work to promote consistency, accountability, and adherence to good laboratory practices
• Establish, monitor and communicate QA KPIs (e.g., deviation rates, training completion, audit findings)
• Drive continuous improvement initiatives using data-driven approaches
• Help ensure quality systems remain inspection-ready and aligned with applicable research, operational, and institutional expectations
• Use Microsoft Office applications and other electronic systems for tracking, trending, reporting, document preparation, communication, and records management
• Practice and advocate safe work habits, including compliance with all safety, health, and environmental rules and regulations

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 in a science field (preferably related to biomedical research). Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of six (6) years of relevant experience in quality assurance, quality control, or laboratory operations in research, clinical, regulated, or another laboratory environment is required
• A minimum of four (4) additional years of supervisory or management experience overseeing staff in a laboratory environment is required
• Demonstrated experience managing quality systems in a laboratory environment
• Experience drafting, reviewing, revising, and maintaining SOPs, forms, and other controlled documents
• Experience with internal audits, readiness assessments, quality observations, and follow-up of remediation activities
• Demonstrated ability to lead quality activities across multiple functional groups performing diverse laboratory and operational work
• Strong understanding of document control, training records, quality event management, corrective and preventive actions, and continuous improvement principles
• Strong verbal and written communication skills with exceptional attention to detail
• Strong interpersonal skills and demonstrated ability to work effectively with scientific, operational, and quality-focused teams
• Computer literacy and proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook, with demonstrated skills in tracking, reporting, and document management
• Ability to analyze information, organize records, identify trends, and present findings clearly and accurately
• Ability to prioritize and manage multiple activities in a fast-paced environment
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:

• Demonstrated management experience in genomics, molecular biology, biorepository, biospecimen processing, or another high-throughput laboratory environment
• Experience overseeing quality assurance activities for a large laboratory organization with multiple teams, functional groups, or locations
• Experience supervising both local and remote quality or operational staff
• Familiarity with quality management systems that include document control, training and competency tracking, inventory and equipment management, maintenance records, safety programs, and waste disposal processes
• Experience managing deviation, nonconformance, CAPA, and risk assessment processes
• Familiarity with CLIA, GLP, ISO, or other applicable laboratory quality or regulatory standards
• Experience with laboratory information management systems (LIMS), electronic laboratory notebooks (ELNs), or other electronic systems used to support laboratory operations and quality oversight
• Experience with data analysis and visualization tools such as Excel, Tableau, or similar platforms
• Exposure to Lean, Six Sigma, business process improvement, or related continuous improvement methodologies
• Proven ability to influence with or without direct authority and to facilitate consensus among teams with diverse perspectives
• Experience training, coaching, or guiding laboratory staff and managers on quality expectations, documentation practices, and good laboratory practices

JOB HAZARDS

• This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
112,600.00 - 161,142.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions
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