Senior Drug Product QA Lead – GMP & CMO Oversight

Cytokinetics; Philadelphia (Philadelphia County); Presencial; USD 134 000 - 156 000; Tempo integral

Resumo da oferta

Cytokinetics, a specialty cardiovascular biopharmaceutical company, is seeking a QA Specialist for Drug Product to provide GMP QA oversight of clinical and commercial manufacturing activities performed by CMOs and external labs.

You will review batch documentation, deviations, CAPAs, change controls and ensure cGMP compliance while supporting technology transfers, process validation and product launches. This role reports to the Associate Director QA and supports QP functions.

Qualificações

• Bachelor's degree in a scientific, engineering or technical discipline is required.
• Minimum 5 years in biopharmaceutical or pharmaceutical QA, with at least 3 years in GMP QA.
• Experience reviewing GMP batch documentation and supporting batch disposition.
• Experience supporting CMOs/CTLs and external manufacturing operations.
• Familiarity with US FDA, EU EMA and ICH cGMP regulations and guidance.

Responsabilidades

• Provide GMP QA oversight for clinical and commercial DP manufacturing, packaging, labeling and distribution with CMOs.
• Review and approve GMP documentation, batch records, specifications, and related QA records.
• Assess quality events and support risk-based quality decisions.
• Support technology transfers, process validation, PPQ, and commercial launch activities.
• Collaborate with Regulatory, Technical Operations, and Supply Chain on CMC activities.
• Participate in audits, inspections, and responses to audit observations.
• Maintain GMP documentation within the eQMS and drive continuous improvement.

Conhecimentos

Excellent communication skills

Strong organizational skills

Project and time management

Cross-functional collaboration

GMP knowledge

Attention to detail

Formação académica

Bachelor's degree in a scientific, engineering or technical discipline

Ferramentas

eQMS (Veeva/TrackWise)

Descrição da oferta de emprego

Cytokinetics, a specialty cardiovascular biopharmaceutical company, is seeking a QA Specialist for Drug Product to provide GMP QA oversight of clinical and commercial manufacturing activities performed by CMOs and external labs.

You will review batch documentation, deviations, CAPAs, change controls and ensure cGMP compliance while supporting technology transfers, process validation and product launches. This role reports to the Associate Director QA and supports QP functions.