Regulatory Document Coordinator and Training Manager

Job description

(ID: 2026-3436) **Axle** is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). **Axle** is seeking a ***Regulatory Document Coordinator and Training Manager*** to join our vibrant team at the National Institutes of Health (NIH) supporting the Division of Facilities Operations and Maintenance (DFOM), Office of the Director (OD), located in **Bethesda, MD.** **Benefits We Offer:** - 100% Medical, Dental & Vision Coverage for Employees - Paid Time Off and Paid Holidays - 401K match up to 5% - Educational Benefits for Career Growth - Employee Referral Bonus - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) **A. Purpose** The contractor staff shall provide facility and building support services for the Division of Facilities Operations and Maintenance (DFOM), Office of the Director (OD), by serving as the DFOM/APF/BSL Document Coordinator and Training Manager. This position provides critical support for federal-regulationmandated documentation and quality control/assurance necessary to operate and maintain the National Institutes of Health (NIH) Aseptic Processing Facilities (APFs) and Biosafety Level (BSL) containment facilities. **B. Background** Aseptic Processing Facilities (APFs) are mission-critical environments required for the development and manufacturing of life-saving therapies, particularly for patients with rare or treatment-resistant conditions who have no other options. NIH operates thirteen (13) APFs under stringent environmental controls — pressure cascades, temperature, relative humidity, and particulate levels — that must be continuously monitored and maintained to comply with FDA regulations. Downtime in APFs can delay or eliminate access to urgently needed treatments and can contribute to avoidable loss of life for patients dependent on these therapies. Biosurety and BSL laboratory compliance similarly depends on maintaining up-to-date documentation and training to protect staff and prevent external exposure risk. These efforts provide a direct regulatory and physical outcome to the quality and safety of human healthcare, and to the safety of NIH patients and staff. Services under this SOW support the facility and building maintenance environment that enables ongoing research and clinical operations to continue. **C. Regulations, Standards, and Guidance Applicable to the Facilities Operations** The contractor’s staff shall create documents that will ensure the Division of Facilities Operations and Maintenance (DFOM) maintains compliance with the following: **Statutes** - 21 U.S.C. § 351 — Federal Food, Drug, and Cosmetic Act (FDCA) - 42 U.S.C. § 262 — Public Health Service Act (PHSA) **Federal Regulations** - 21 CFR Part 210 — Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs - 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals (including 211.42(c) and 211.46(b)) - 21 CFR Part 600 — Biological Products: General - 42 CFR Part 73 — Select Agents and Toxins (biosurety) - (HHS) **Standards and Guidance** - USP General Chapter <797> — Pharmaceutical Compounding – Sterile Preparations - USP General Chapter <800> — Hazardous Drugs – Handling in Healthcare Settings - FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - ISPE Baseline Guide: Volume 3 (Sterile Product Manufacturing Facilities) - ISO 14644-4 — Cleanrooms and Associated Controlled Environments - CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) **D. Scope** This SOW is organized into distinct requirement areas. Each area is independently defined below; collectively they constitute the full scope of the required support. **1) Requirement Area 1 — Document Lifecycle Management** The contractor staff shall manage the full lifecycle of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Training Modules for DFOM's APF and BSL operations, including: - Initial creation and drafting of new SOPs, WIs, and Training Modules in accordance with DFOM templates and formatting standards. - Coordination of periodic review cycles to ensure documents remain current and technically accurate. - Management of the revision process, including tracking requested changes and incorporating approved edits. - Facilitation of the approval process, ensuring required approvers review and sign off within established timeframes. - Management of distribution to ensure approved documents reach relevant personnel (see Requirement Area 3 for controlled distribution specifics). - Management of document retirement and expiration, including archival of superseded or obsolete documents. **2) Requirement Area 2 — Document Control and Records Management** The contractor staff shall utilize the NIH document control system that ensures compliance with organizational and regulatory recordkeeping requirements, including: - Maintenance of detailed version control records for all SOPs, WIs, and Training Modules. - Tracking of authorship for each document and revision. - Maintenance of complete revision history for each controlled document. - Tracking of approval status (pending, approved, rejected, returned for revision) for each document in the workflow. - Recording and monitoring effective data for all approved documents. - Monitoring of document expiration timelines and proactive initiation of review or archival processes as review/expiration dates approach. **3) Requirement Area 3 — Cross-Functional Review Coordination and Controlled Distribution** The contractor staff shall coordinate document review activities and manage controlled access to current documentation, including: - Coordination of cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy. - Verification that document content is consistent with current DFOM policies and procedures. - Verification that document content aligns with applicable industry standards and regulatory requirements (see Section 3). - Oversight of controlled distribution processes to ensure that only the most current, approved versions of documents are accessible to relevant personnel. - Removal or restriction of access to superseded or expired document versions. **4) Requirement Area 4 — Personnel Training Management and Compliance Tracking** The contractor staff shall track and manage personnel training status in direct linkage with the document control system, including: - Linking of Training Modules to the specific SOPs and WIs they support. - Tracking of individual employee training status against required modules. - Monitoring to ensure all employees complete required training within designated timeframes. - Maintenance of up-to-date, auditable training records for all applicable personnel. - Generation of compliance reports summarizing training completion status across DFOM/APF/BSL personnel. - Support of internal and external audits by providing documentation of employee qualifications and training adherence upon request. **E. Place of Performance** NIH campus: 13 South Drive, Bethesda - MD 20892 **F. Deliverables** | | | | | | --- | --- | --- | --- | | **#** | **Deliverable** | **Frequency** | **Format/Standard** | | 1 | SOP/WI/Training Module Master Index & Status Log | Monthly / on-demand | Electronic log, version-controlled | | 2 | New/Revised SOP, WI, and Training Module Drafts | As triggered by reviewing cycle or business need | Per DFOM document template | | 3 | Document Review & Approval of Routing Records | Continuous, reported monthly | QMS system record/export | | 4 | Document Expiration/Review Forecast Report | Monthly | Report (e.g., 30/60/90-day expiration lookahead) | | 5 | Controlled Distribution Confirmation Records | Continuous | QMS/distribution log | | 6 | Personnel Training Status & Training Quiz/Assessment Report | Monthly | Report tied to SOP/WI-linked training modules | | 7 | Quarterly Program Status Report | Quarterly | Narrative + metrics (docs processed, training compliance %, overdue items) | | 8 | Annual Program Summary | Annually | Narrative report to COR/DFOM leadership | | 9 | QMS Account Management Report | Monthly | QMS Report | **Disclaimer:** The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed. The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate. Accessibility: If you need an accommodation as part of the employment process please contact: [careers@axleinfo.com](mailto:careers@axleinfo.com) This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location. Salary Range $90,000—$100,000 USD