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.

Responsibilities

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 records

• 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

Qualifications

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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We are seeking an experienced Director of Quality Assurance, Alliance Management to join our growing global organization. As Cytokinetics expands through strategic in-licensing partnerships with regional market leaders, this role will be critical in ensuring that all quality and compliance aspects of these partnerships are effectively established and maintained.

This position will lead and coordinate Quality Assurance activities across partner relationships, ensuring alignment with global regulatory requirements and internal standards. The successful candidate will act as a key liaison between Cytokinetics and its partners, supporting both the onboarding of new alliances and the ongoing management of established collaborations.

The role reports to the Head of Quality Assurance Operations and works closely with Alliance Management, Technical Operations, Regulatory CMC, and other cross-functional teams.

Key Responsibilities

• Serve as a core member of the QA Operations team and Point of Contact (POC), coordinating quality requirements arising from partnership activities, in partnership with alliance management teams
• Lead and manage all Quality Assurance activities related to the onboarding of new partners
• Develop scalable frameworks, models, and processes for partner onboarding and QA integration
• Act as the lead for partner-related Quality Assurance audits
• Develop standards for Quality Agreements supporting in-licensing partnerships in collaboration with Quality Compliance
• Review and approve (as applicable) change controls, deviations, investigations, procedures, and CAPAs related to partner supply
• Participate in Quality Management Review meetings, providing input on partnership-related quality topics
• Collaborate with Quality Systems and Compliance to ensure the QMS meets market-specific regulatory requirements associated with partnerships
• Ensure timely and effective resolution of quality issues related to product supply for partners
• Conduct risk assessments and implement appropriate controls when onboarding new partners
• Partner with Technical Operations, Regulatory CMC, and other functions to ensure GMP compliance across new markets and partnerships
• Support review of Product Quality Reviews (PQRs) as part of partner oversight
• Represent the QA function in cross-functional and external meetings, making decisions within scope of responsibility
• Promote a culture of quality, compliance, and continuous improvement across the organization
• Identify and lead initiatives to enhance quality systems, processes, and practices

Qualifications & Experience

• Bachelor’s degree (BSc) or higher in a relevant scientific discipline
• Minimum of 10 years’ experience in pharmaceutical or biopharmaceutical manufacturing and quality functions
• Strong knowledge of global cGMP regulations and emerging regulatory trends
• Experience in a biopharma or pharmaceutical start-up environment,
• Preference for experience hosting regulatory inspections and/or partner/client audits
• Demonstrated ability to influence and collaborate effectively across all organizational levels
• Experience working with external partners, alliances, or contract organizations
• Strong ability to work independently, demonstrating initiative and sound judgment
• Excellent organizational skills with the ability to manage multiple priorities effectively
• Strong written and verbal communication skills
• Proficiency in Microsoft Office applications
• Fluency in English; additional language(s) are an advantage
• Willingness to travel up to 15% annually
  
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