GMP Quality Lead

Granules Pharmaceuticals, Inc.; Suffolk (VA); In loco; USD 70.000 - 80.000; Tempo pieno

Descrizione del lavoro

Granules Pharmaceuticals, Inc. is seeking a Quality Lead to ensure cGMP compliance across documentation, releases, deviations, CAPAs, and audits. The role supports continuous improvement within a robust QMS and maintains an inspection-ready environment.

It requires strong cross-functional collaboration and experience with regulatory requirements. The position is an individual contributor role with growth potential into people management, reporting to the Site Head QA (Chantilly) with secondary

Competenze

• Bachelor's degree in Life Sciences or related field with 5+ years in pharma/biotech.
• Experience with regulatory audits and distribution quality ops is required.
• Experience managing contract manufacturers and QA documentation.

Mansioni

• Manage GMP document lifecycle (issuance, revision, archival).
• Author/review SOPs, batch records, forms for compliance.
• Maintain QA databases and document repositories; ensure inspection readiness.
• Track and review logbooks, change requests, and required records.
• Coordinate investigations, deviations, CAPAs, and root-cause analysis.
• Support inspections, sampling, shipment review, and material disposition.
• Assist audits, vendor qualifications, APQRs, and QA programs.
• Provide training on DEA, GMPs, and quality procedures.

Conoscenze

cGMP/GxP

FDA regulations

QMS processes

TrackWise

Veeva

Documentation

Audits

Analytical skills

Communication

Regulatory compliance

Formazione

Bachelor's degree in Life Sciences

Strumenti

TrackWise

Veeva

Microsoft Office

Descrizione del lavoro

Granules Pharmaceuticals, Inc. is seeking a Quality Lead to ensure cGMP compliance across documentation, releases, deviations, CAPAs, and audits. The role supports continuous improvement within a robust QMS and maintains an inspection-ready environment.

It requires strong cross-functional collaboration and experience with regulatory requirements. The position is an individual contributor role with growth potential into people management, reporting to the Site Head QA (Chantilly) with secondary