Regulatory Document Coordinator and Training Manager

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