Senior Drug Substance QA Lead

Cytokinetics; San Francisco (CA); In loco; USD 140.000 - 164.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401k retirement

Paid time off

Stock options

Descrizione del lavoro

Cytokinetics is seeking a QA Specialist for Drug Substance to provide GMP QA oversight and review of manufacturing documentation with CMOs, CTLs, and other partners. You will support QMS activities, deviations, CAPAs, and regulatory readiness in a fast-paced environment.

The role requires 5+ years in biopharma QA, cGMP knowledge, and experience with oral solid dose operations. On-site collaboration with cross-functional teams is essential.

Competenze

• Bachelor's degree in a scientific, engineering or technical discipline.
• 5+ years of biopharmaceutical/pharmaceutical QA experience with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial pharmaceutical manufacturing.
• Experience with oral solid dose manufacturing and packaging.
• Experience reviewing GMP batch documentation and supporting batch disposition.

Mansioni

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing at CMOs.
• Review batch records and supporting documentation to ensure cGMP compliance and release.
• Review and approve deviations, investigations, CAPAs, change controls, and related QMS records.
• Support technology transfers, process validation activities, PPQ and commercial launches.
• Participate in internal audits, supplier audits and regulatory inspections and assist responses to observations.

Conoscenze

QA

GxP

cGMP

Documentation review

Deviations

CAPA

Change controls

CMO oversight

Audit support

eQMS

Veeva Quality

TrackWise

Formazione

Bachelor's degree in science/engineering/technical discipline

Strumenti

Veeva Quality

TrackWise

Descrizione del lavoro

Cytokinetics is seeking a QA Specialist for Drug Substance to provide GMP QA oversight and review of manufacturing documentation with CMOs, CTLs, and other partners. You will support QMS activities, deviations, CAPAs, and regulatory readiness in a fast-paced environment.

The role requires 5+ years in biopharma QA, cGMP knowledge, and experience with oral solid dose operations. On-site collaboration with cross-functional teams is essential.