Quality Lead - GMP & QMS Champion

Granules Pharmaceuticals, Inc.; Suffolk (VA); On-site; USD 70,000 - 80,000; Full time

Job summary

Granules Pharmaceuticals, Inc. is seeking a Quality Lead to ensure cGMP compliance and effective quality systems across documentation, release, deviations, CAPAs, and audits.

You will support continuous improvement and maintain inspection-ready environments, with potential growth into people management. In Suffolk, VA, this role focuses on QA activities for distribution quality operations, coordination with internal/external stakeholders, and ensuring timely completion of quality initiatives

Qualifications

• Bachelors degree in Life Sciences or regulatory field with 5+ years in pharma.
• Experience with regulatory audits and distribution quality operations.
• Experience managing contract manufacturers is a plus.

Responsibilities

• Manage lifecycle of controlled GMP documents (issuance, revision, archival).
• Author and maintain SOPs, batch records, forms for compliance.

Skills

cGMP knowledge

QMS processes

TrackWise

Veeva

Documentation

Analytical skills

Communication

Education

Bachelor's degree in Life Sciences or related field

Tools

TrackWise

Veeva

Microsoft Office

Job description

Granules Pharmaceuticals, Inc. is seeking a Quality Lead to ensure cGMP compliance and effective quality systems across documentation, release, deviations, CAPAs, and audits.

You will support continuous improvement and maintain inspection-ready environments, with potential growth into people management. In Suffolk, VA, this role focuses on QA activities for distribution quality operations, coordination with internal/external stakeholders, and ensuring timely completion of quality initiatives