The Quality Associate support will initially provide approximately 20 hours per week of support across the following key areas
Document Creation and Execution Support
Preparation, formatting, and maintenance of QA documentation within Veeva
Coordination of document lifecycle activities including review and version control
Ensuring adherence to internal documentation standards
Complaints Management Support
Initiating and tracking of customer complaints
Supporting data entry, documentation, and follow-up activities
Assisting in maintaining audit-ready complaint record
CMO Scorecard Development
Supporting data collection and consolidation for CMO performance metrics
Assisting in the preparation and formatting of scorecards and reports
Maintaining consistency and accuracy in reporting outputs
Distribution and Quality Disposition Support
Coordinating distribution of quality-related documents and communications e.g. disposition returns
Supporting quality disposition processes and maintaining executed record logs e.g Temperature excursions
Facilitating communication between internal and external stakeholders as needed
Bona Fide Customer Checks
Conducting verification checks on customers
Maintaining accurate and traceable records of compliance activities
Supporting QA in meeting regulatory and internal compliance requirements
General Administrative Support (Ad Hoc)
Event and meeting organization
Additional administrative duties as required
Requirements
Required Qualifications
Bachelor's degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline
Approximately 5 years of hands-on experience in a life sciences Quality environment (biotech, pharmaceutical, medical device, or regulated healthcare industry)
Demonstrated experience supporting Quality Assurance (QA) and Quality Management System (QMS) activities
Strong working knowledge of GxP requirements (e.g., GMP, GDP) and regulated documentation practices
Proven experience with document creation, formatting, execution, and lifecycle management within an electronic document management system (e.g., Veeva Vault or similar)
Experience supporting complaints management processes, including documentation, tracking, and maintenance of audit-ready records
High attention to detail with the ability to maintain accurate, compliant, and traceable records
Strong organizational and time management skills, with the ability to manage multiple tasks and prioritize effectively in a part-time (approximately 20 hours/week) support role
Excellent written and verbal communication skills, with the ability to interact professionally with internal and external stakeholders
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), particularly for data consolidation, tracking, and reporting
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Pay Range:
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Benefits
Health insurance
Additional Information
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.
Job purpose
The role will provide structured assistance across document management, complaints handling, reporting, and general administrative activities. Securing this support will improve operational efficiency, strengthen compliance, and enable QA professionals to focus on high-value quality and oversight responsibilities. The Quality Department operates in a highly regulated environment with increasing demands related to documentation, customer assurance, and quality reporting. QA administrative workload has grown significantly, particularly in areas such as complaints management, CMO scorecard development, and compliance checks.
Cytokinetics · Ireland