GMP Quality Lead & Regulatory Compliance

Granules Pharmaceuticals Inc.; Suffolk (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Granules Pharmaceuticals Inc. seeks a Quality Lead to ensure cGMP compliance across documentation, inspections, release of materials and products, deviations, CAPAs, change controls, audits, and continuous improvement initiatives.

This individual contributor role offers growth into people management and requires strong QA knowledge in a regulated environment. Responsibilities include managing controlled documents, maintaining QA systems, and collaborating with multiple departments to sustain an

Qualifications

• Strong knowledge of cGMP/GxP, FDA regulations, and related quality standards.
• Experience with QMS processes including deviations, CAPAs, change controls, and audits.
• Experience with pharmaceutical warehouse management and contract manufacturers.
• Excellent written and verbal communication and attention to detail.

Responsibilities

• Manage the lifecycle of controlled GMP documents.
• Author, review, and maintain SOPs, protocols, and batch records.
• Maintain QA databases and document repositories.
• Coordinate investigations, non-conformances, and customer complaints.
• Support inspections, sampling, shipment review, and material disposition.
• Lead quality training and cross-functional collaboration.
• Identify and elevate quality/compliance risks and drive continuous improvement.
• Support audits, vendor qualifications, and APQRs.
• Provide guidance on quality systems and regulatory requirements.

Skills

Regulatory compliance

Quality systems

Documentation management

Analytical skills

Communication skills

Cross-functional collaboration

Education

Bachelor's in Life Sciences or related

Tools

TrackWise

Veeva

Microsoft Office

Job description

Granules Pharmaceuticals Inc. seeks a Quality Lead to ensure cGMP compliance across documentation, inspections, release of materials and products, deviations, CAPAs, change controls, audits, and continuous improvement initiatives.

This individual contributor role offers growth into people management and requires strong QA knowledge in a regulated environment. Responsibilities include managing controlled documents, maintaining QA systems, and collaborating with multiple departments to sustain an