QA Drug Substance Lead — GMP Oversight & CMO Collaboration

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 140,000 - 164,000; Full time

Benefits offered by this job

Stock options

Health insurance

401k match

Paid time off

Job summary

Cytokinetics, Inc. in South San Francisco, CA, is seeking a QA Specialist for Drug Substance to perform review of batch documentation as part of QA certification. The role provides QA support to CMOs, CTLs, and other GMP service providers and supports the Qualified Person function.

You will review GMP batch docs, deviations, CAPAs, change controls, and participate in audits, inspections, and QA metrics reporting while helping ensure compliance with cGMP and regulatory expectations.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• At least 5 years in biopharma/pharma with ≥3 years in GMP QA.
• Experience supporting clinical and/or commercial pharmaceutical manufacturing.
• Experience with oral solid dose manufacturing and packaging.
• Working knowledge of US FDA, EU EMA and ICH cGMP regulations.
• Experience reviewing GMP batch documentation and batch disposition activities.
• Experience managing deviations, investigations, CAPAs, change controls and other Quality System records.
• Experience supporting CMOs and external manufacturing operations.
• Experience participating in GMP audits and regulatory inspections.
• Excellent written and verbal communication with cross-functional collaboration.
• Strong organizational skills with ability to manage multiple priorities.
• Experience authoring SOPs and controlled GMP documentation.
• Experience using eQMS, preferably Veeva Quality or TrackWise.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing at CMOs.
• Review batch records and supporting documentation for cGMP compliance.
• Review documentation to support batch disposition and product release.
• Review and approve deviations, investigations, CAPAs, and change controls.
• Assess quality events for potential product impact and risk.
• Support technology transfers, process validation, PPQ and product launches.
• Review GMP documentation including SOPs, Master Batch Records, specs and protocols.
• Participate as QA representative on cross-functional teams.
• Support manufacturing process improvements through change management.
• Ensure compliance with Cytokinetics QMS and regulatory expectations.
• Support qualification and ongoing QA oversight of CMOs and labs.
• Participate in internal audits, supplier audits and regulatory inspections.
• Support Product Quality Reviews, APRs and QA metrics reporting.
• Collaborate with Regulatory Affairs, Operations and Supply Chain on CMC submissions.
• Maintain GMP documentation in the eQMS.
• Identify opportunities to improve quality systems and GMP processes.
• Provide guidance to internal and external stakeholders on GMP requirements.
• Perform other QA duties to support business objectives.

Skills

GMP Quality Assurance

Documentation review

cGMP regulations

CAPA management

Deviation handling

Audit support

CMO oversight

Quality systems

Regulatory knowledge

SOP authoring

Education

Bachelor's degree

Tools

eQMS

Veeva Quality

TrackWise

Job description

Cytokinetics, Inc. in South San Francisco, CA, is seeking a QA Specialist for Drug Substance to perform review of batch documentation as part of QA certification. The role provides QA support to CMOs, CTLs, and other GMP service providers and supports the Qualified Person function.

You will review GMP batch docs, deviations, CAPAs, change controls, and participate in audits, inspections, and QA metrics reporting while helping ensure compliance with cGMP and regulatory expectations.