Quality Lead

The Quality Lead supports compliance with cGMP, company policies, procedures, and applicable regulatory requirements. This role oversees and supports quality activities including documentation, inspections, material and product review/release, deviations, CAPAs, change controls, audits, SOPs, and continuous improvement initiatives. The position helps maintain effective Quality Management Systems and a compliant, inspection-ready environment. This is an individual contributor role with room to grow into a people management role.

JOB DUTIES & RESPONSIBILITIES INCLUDE BUT NOT LIMITED TO:

• Manage the lifecycle of controlled GMP documents, including issuance, revision, version control, retention, and archival.
• Author, review, and maintain SOPs, protocols, reports, batch records, forms, and other quality documents for accuracy and compliance.
• Maintain QA databases, document repositories, and tracking systems in an accurate and inspection-ready state.
• Track and review controlled documents, logbooks, change requests, and required records for timely completion.
• Ensure compliance with cGMP, DEA, SOPs, quality standards, and applicable regulatory requirements.
• Manage and support Quality Management System (QMS), including deviations, CAPAs, change controls, complaints, investigations, and timely record closure.
• Coordinate and assess investigations, non-conformances, and customer complaints to identify root causes, evaluate quality and operational impact, and support appropriate corrective actions.
• Perform or support inspections, sampling, shipment review, and material disposition, as applicable.
• Support warehouse and distribution quality activities, including records and logbook reviews, environmental monitoring, material/component control, inventory-related quality activities, and issue resolution.
• Support audits, inspections, vendor qualifications, validation, Annual Product Quality Reviews (APQRs), and other quality/compliance programs.
• Identify and escalation quality or compliance risks, support continuous improvement, and maintain an inspection-ready environment.
• Support GMP and quality training, including assignments, tracking, and training records.
• Provide new hire training on DEA, GMPs, Safety, Pharmacovigilance, and other requirements.
• Reinforce employee understanding of SOPs, quality procedures, and compliance requirements.
• Partner with internal and external stakeholders to resolve quality issues and ensure timely completion of quality activities.
• Collaborate on investigations, change controls, validation, and other quality initiatives.
• Provide cross-functional guidance on quality systems, documentation, and regulatory requirements.

• Maintain knowledge of pharmaceutical serialization requirements, as applicable.
• Work weekends or off-hours as business needs require.
• Perform other duties as assigned.

Primary (direct manager):
Site Head, QA (Chantilly)

Secondary (on-site):
Site Head, Distribution (Suffolk)

Internal Contacts:
Quality Assurance, Operations, HR, Supply Chain/Warehouse, IT/Systems

External Contacts:
Regulatory Inspectors and Auditors, Contract Manufacturers and packagers

Strong knowledge of cGMP/GxP, FDA, Title 21 of the Code of Federal Regulations and Compendia, Good Documentation Practices, and applicable pharmaceutical regulatory requirements. Knowledge of QMS processes, including deviations/investigations, CAPAs, change controls, complaints, audits, and controlled document management. Knowledge of working in Quality management related to pharmaceutical warehouse management and contract manufacturers. Proficiency with QMS/EDMS platforms (e.g., Track Wise, Veeva)…