Quality Lead — GMP & Compliance, QMS Expert

GRANULES CONSUMER HEALTH LLC; Suffolk (VA); On-site; USD 110,000 - 140,000; Full time

Job summary

GRANULES CONSUMER HEALTH LLC seeks a Quality Lead to support cGMP compliance, doc control, and QA activities across SOPs, deviations, CAPAs, and audits. This individual contributor role offers growth into people management and requires strong regulatory knowledge and cross-functional collaboration.

The position focuses on maintaining inspection-ready QA systems, managing controlled documents, and supporting vendor qualifications and APQRs, while partnering with internal teams to drive continuous

Qualifications

• Bachelor's degree in Life Sciences or related field with at least 5 years in pharma.
• Experience with regulatory audits and distribution quality operations.
• Experience managing contract manufacturers.

Responsibilities

• 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, APQRs, and other quality programs.
• Identify and elevate 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.

Skills

cGMP knowledge

FDA regulations

Quality management

Documentation practices

Analytical skills

Writing and communication

Cross-functional collaboration

Education

Bachelor's degree Life Sciences

Regulatory Affairs

Document Control

Tools

TrackWise

Veeva

Microsoft Office

Job description

GRANULES CONSUMER HEALTH LLC seeks a Quality Lead to support cGMP compliance, doc control, and QA activities across SOPs, deviations, CAPAs, and audits. This individual contributor role offers growth into people management and requires strong regulatory knowledge and cross-functional collaboration.

The position focuses on maintaining inspection-ready QA systems, managing controlled documents, and supporting vendor qualifications and APQRs, while partnering with internal teams to drive continuous