Manager, Training & Compliance

Job ID: req3013
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.

This position is planned to be fully remote; however, may require some onsite attendance occasionally.

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

• Oversee the development, implementation and maintenance of quality assurance systems and activities.
• Oversee generation and review of documents used in good manufacturing practices.
• Coordinate interdepartmental activities.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.
• Supervise at least three (3) QA Specialists, assigning tasks and ensuring workload is distributed evenly across the group.
• Conduct employee performance reviews and approve employee leave and timesheets.
• Train and mentor junior staff on interdepartmental processes.
• Participate in the oversight and management of the site-wide training program and QA compliance program activities.
• Lead and facilitate special projects associated with the training program and QA compliance department.
• Interact with senior management and client, as needed.
• Provide reports on a routine basis to Senior Management and QA management.
• Support QA management in the establishment and implementation of quality systems in accordance with cGMP.
• Provide cross-departmental support to resolve training and quality related issues associated with compliance as they relate to observations, deviations, non-conformances, corrective actions, and/or preventive actions.
• Train and mentor VCMP staff in activities critical to the success of the training program and compliance department.
• Independently write, implement, and improve controlled documents (i.e., SOPs, Policies, Protocols) which may entail significant system changes.
• Demonstrate ability to document and present data, information, status, and solutions through documentation, flowcharts, layouts, diagrams, charts, and reports.
• Maintain the QA training manager role and act as back-up to the business owner for MasterControl (VCMP Learning
• Management System) for activities associated with the training program.
• Act as training administrator for the QA department which includes, but is not limited to, assisting department management in the creation of learning plans, curricula, and/or courses; as well as, assisting QA department management with ensuring training is maintained up to date and job codes are adequate.
• When needed, conduct trainings, assist other training administrators with learning plans, curricula, and/or courses.
• When needed, perform final quality review/assessment of training plans, validation documentation, GMP documentation, change controls, etc.

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) in a scientific related or related field 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, a minimum of six (6) years of progressively responsible quality assurance and/or training experience, including four (4) years of experience in a leadership/manager capacity.
• Experience with FDA regulations for cGMP and knowledge of WHO Part 3.
• Experience with the developing learning plans, training courses, and/or training programs.
• Experience as a trainer.
• Experience in the review of test records, deviations, CAPAs, and change controls .
• Working knowledge of Microsoft Office.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Combination of Training, QA, QC or manufacturing experience.
• Working knowledge of quality systems and Master Control.
• Experience with the GMP manufacture of Phase I/II clinical material.
• Ability to clearly summarize and communicate with all levels of staff.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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