Senior Quality Assurance Specialist - Drug Substance

Cytokinetics (Ireland) Limited; Ireland; Hybrid; EUR 78,000 - 98,000; Full time

Job summary

Cytokinetics (Ireland) Limited is seeking a QA Specialist for Drug Substance to provide GMP QA oversight across clinical and commercial manufacturing activities. The role involves review of batch documentation, deviation handling, CAPAs and change controls, with support to the QP function.

The successful candidate will collaborate with Regulatory Affairs, Technical Operations and Supply Chain, participate in audits and inspections, and drive continuous improvement within Cytokinetics' Quality

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum 5 years of experience in biopharmaceutical or pharmaceutical QA with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial manufacturing.
• Experience reviewing GMP batch documentation and supporting batch disposition activities.
• Experience auditing CMOs/contract labs and supporting regulatory inspections.
• Excellent written and verbal communication across functions.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing and distribution activities at CMOs/CTLs.
• Review batch records and supporting documentation to ensure compliance with cGMP and regulatory filings.
• Review and approve deviations, investigations, CAPAs, change controls and QMS records.
• Assess quality events for product impact and support risk-based quality decisions.
• Support technology transfers, process validation, PPQ and commercial launch activities.
• Participate in internal and regulatory audits and inspection readiness.

Skills

GMP Quality Assurance

QA Documentation Review

Regulatory Compliance

Internal/External Audits

Cross-functional Collaboration

cGMP Experience

Documentation Management

eQMS Systems Familiarity

Education

Bachelor's degree in scientific, engineering or technical discipline

Tools

Veeva Quality

TrackWise

eQMS software

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. 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. The candidate will be part of a team that provides QA support and advice to internal and external customers and will execute day-to-day quality issues as they arise at Cytokinetics. They will be part of teams who work with Contract Manufactures for Drug product (DP). The role will provide support to the Qualified Person (QP) function to oversee our QA activities as we continue to supply our products.

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.

#LI-HYBRID Pay Range: The salary range for this role is €78,400-€98,000 gross annually. Final compensation will depend on skills, experience, and internal equity considerations. In line with Ireland equal pay regulations, we apply objective, gender-neutral criteria to determine compensation. We actively monitor pay equity through our annual Gender Equality Index and are committed to maintaining fair and transparent pay practices. In compliance with Ireland pay transparency legislation, compensation for this role is based on objective criteria and is aligned with our company-wide salary register. We are committed to ensuring equal pay for work of equal value.

Our employees come from different backgrounds, and we celebrate those differences. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Cytokinetics is an Equal Opportunity Employer

Please visit our website at: www.cytokinetics.com