Senior Quality Assurance Specialist - Drug Substance
Cytokinetics
Summary
Reporting to the Associate Director for QA at Cytokinetics the QA Specialist for Drug Substance will perform review of batch documentation as part of the QA certification process. The role involves oversight and review of documentation relating to manufacturing, testing, release, and lifecycle management activities performed by Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and other GxP service providers.
Job description
Responsibilities
- Provide GMP Quality Assurance oversight for clinical and commercial manufacturing, and distribution activities performed at Contract Manufacturing Organizations (CMOs).
- Perform Quality review of clinical and commercial batch records and supporting documentation to ensure compliance with cGMP requirements, approved manufacturing instructions and regulatory filings.
- Review manufacturing, and testing documentation to support batch disposition and product release.
- Review and approve deviations, investigations, CAPAs, change controls and associated Quality Management System records to ensure timely resolution and appropriate root cause analysis.
- Assess quality events for potential product impact and support risk-based quality decisions.
- Provide Quality support for technology transfers, process validation, engineering batches, process performance qualification (PPQ) and commercial launch activities.
- Review and approve GMP documentation including Standard Operating Procedures (SOPs), Master Batch Records, specifications, protocols, reports and work instructions.
- Participate as the Quality representative on cross-functional teams supporting clinical and commercial programs.
- Support implementation of manufacturing, packaging and process improvements through the change management process.
- Ensure compliance with Cytokinetics Quality Management System requirements, cGMP regulations and applicable global regulatory expectations.
- Support qualification and ongoing Quality oversight of CMOs, contract laboratories and other GMP service providers.
- Participate in internal audits, supplier audits and regulatory inspections, including inspection readiness activities and support for responses to audit observations.
- Support Product Quality Reviews (PQRs), Annual Product Reviews (APRs), Quality Management Reviews and Quality Metrics reporting.
- Collaborate with Regulatory Affairs, Technical Operations, Supply Chain and Manufacturing partners to support CMC submissions, post-approval changes and regulatory commitments.
- Maintain GMP documentation and Quality records within the electronic Quality Management System (eQMS).
- Identify opportunities to improve Quality Systems and GMP processes and participate in continuous improvement initiatives.
- Provide guidance to internal stakeholders and external partners on GMP quality requirements.
- Perform other Quality Assurance duties as assigned to support business objectives.
Minimum Qualifications
- Bachelor's degree in a scientific, engineering or technical discipline.
- Minimum of 5 years of experience within the biopharmaceutical or pharmaceutical industry, with at least 3 years in GMP Quality Assurance.
- Experience supporting clinical and/or commercial pharmaceutical manufacturing.
- Experience with oral solid dose pharmaceutical manufacturing and packaging.
- Working knowledge of US FDA, EU EMA and ICH cGMP regulations and industry guidance.
- Experience reviewing GMP batch documentation and supporting batch disposition activities.
- Experience managing or reviewing deviations, investigations, CAPAs, change controls and other Quality System records.
- Experience supporting Contract Manufacturing Organizations (CMOs) and external manufacturing operations.
- Experience participating in GMP audits and regulatory inspections.
- Excellent written and verbal communication skills with the ability to work effectively across multiple functions and external partners.
- Strong organizational skills with the ability to manage multiple priorities while maintaining attention to detail.
- Experience authoring and reviewing SOPs and controlled GMP documentation.
- Experience using electronic Quality Management Systems (eQMS), preferably Veeva Quality, TrackWise or similar platforms.
Preferred Qualifications
- Experience supporting commercial product launches.
- Experience supporting technology transfer and process validation activities.
- Knowledge of ICH Q7, Q8, Q9 and Q10 guidance.
- Experience working within a global external manufacturing network.
- Continuous improvement or Lean Six Sigma experience is desirable.
Requirements
- Bachelor's degree in a scientific, engineering or technical discipline.
- Minimum of 5 years of experience within the biopharmaceutical or pharmaceutical industry, with at least 3 years in GMP Quality Assurance.
- Experience supporting clinical and/or commercial pharmaceutical manufacturing.
- Experience with oral solid dose pharmaceutical manufacturing and packaging.
- Working knowledge of US FDA, EU EMA and ICH cGMP regulations and industry guidance.
- Experience reviewing GMP batch documentation and supporting batch disposition activities.
- Experience managing or reviewing deviations, investigations, CAPAs, change controls and other Quality System records.
- Experience supporting Contract Manufacturing Organizations (CMOs) and external manufacturing operations.
- Experience participating in GMP audits and regulatory inspections.
- Excellent written and verbal communication skills with the ability to work effectively across multiple functions and external partners.
- Strong organizational skills with the ability to manage multiple priorities while maintaining attention to detail.
- Experience authoring and reviewing SOPs and controlled GMP documentation.
- Experience using electronic Quality Management Systems (eQMS), preferably Veeva Quality, TrackWise or similar platforms.
Benefits
- Stock options
- Restricted stock units
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) Matching
- Learning stipends
- Wellness stipends
- Paid time off
Company overview
Cytokinetics, Incorporated is a late-stage biopharmaceutical company headquartered in South San Francisco, California, specializing in muscle biology research and drug development. Founded in 1997 by leading scientists from Stanford, UCSD, and UCSF, the company focuses on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for debilitating diseases characterized by impaired or declining muscle function. With over 25 years of scientific expertise, Cytokinetics has built a robust pipeline targeting cardiovascular and neuromuscular conditions including heart failure, hypertrophic cardiomyopathy, and amyotrophic lateral sclerosis (ALS). The company's innovative approach centers on directly targeting the sarcomere, the fundamental unit of muscle contraction, to develop potential treatments that may preserve and extend independence for patients. Cytokinetics operates as a publicly traded company (NASDAQ: CYTK) and has established itself as a leader in muscle biology with more than 115 publications, over 100 clinical trials, and hundreds of issued patents.