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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Job purpose

As the Associate Director, External Manufacturing and Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within Manufacturing and External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Director, External Supply Operations.

Responsibilities

• Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues
• Ensure timely and effective execution of all manufacturing and supply plans at assigned CMO’s
• Develop and manage production processes to support operational execution, including BOM’s, specifications, CAPA’s, change controls, master data, and artwork. Familiarity with ERP/MRP systems
• Support logistics, transportation and import/export activities
• Act as the manufacturing and supply chain representative for review and approval of documentation including but not limited to batch records, BOM’s, specifications, artwork, and change control
• Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls
• Play a key role in supporting selection and onboarding of new CMOs, technical transfers, operationalizing product supply and site establishment
• Manage and track inventory, perform inventory reconciliations, and support month end close process.
• Issue purchase orders, and track invoices and budgets
• Maintain production schedules and track batch record execution in coordination with Quality
• Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation
• Proven risk management acumen with a continuous improvement mindset
• Where necessary, provide input to the manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
• Build and maintain strong partnerships and provide effective communication with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded
• Responsible for scheduling and maintaining routine business operations meetings with CMO’s
• Support Regulatory submissions and CMC as required

Qualifications

Education & Core Experience

• BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired
• 10+ years’ combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry
• cGMP career experience embedded in a pharmaceutical manufacturing plant is essential – with first-hand knowledge of plant operations, with the insight to assess performance, and diagnose issues directly at the source
• Technical background with knowledge of engineering and pharmaceutical manufacturing processes in small molecules is required, and experience in DS/API production is desirable
• Excellent problem-solving skills, with the ability to address complex challenges under time pressure
• Demonstrated expertise in risk management, with a history of successfully implementing risk mitigation strategies
• Hands-on investigations/RCA (OOS/OOT/deviations) and continuous improvement at external sites
• The ability to function in a fast-paced, high-growth, entrepreneurial environment
• Ability to travel domestically and internationally ~25%
• Position requires a strong working knowledge and understanding of both regional and international regulations by government agencies affecting the pharmaceutical industry (CFR's, EU GMP, ICH)
• Timely and effective communication across multiple audiences, both verbally and in writing
  
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Job purpose

We are seeking a Director of Packaging & Artwork Management to lead the strategy, systems, and execution of artwork lifecycle management. Reporting to the VP of External Manufacturing, this role will build inspection-ready, scalable, and fit-for-purpose artwork capabilities, with a strong emphasis on Global market requirements. This role is accountable for establishing end-to-end artwork management, including system selection and validation, intake and workflow design, lifecycle processes, and regulatory alignment. The leader will operate in a fast-paced, resource-constrained environment, balancing compliance, speed, and efficiency while supporting global commercialization.

Responsibilities

Artwork Strategy & Systems

• Define and implement a scalable global artwork strategy aligned to company growth.
• Lead selection, validation, and deployment of Artwork Management Systems (AMS), including:
• Ensure systems are GxP-compliant, right-sized, and integrated with Regulatory, Quality, and ERP platforms as appropriate.

Intake, Triage & Workflow Management

• Establish a centralized intake and prioritization model for artwork requests across products and markets.
• Implement governance and prioritization frameworks (launches, lifecycle changes, safety updates).
• Deploy tracking tools and dashboards to provide visibility into timelines, risks, and bottlenecks.
• Align artwork demand with regulatory submissions and manufacturing schedules.

Artwork Lifecycle Management

• Design and implement end-to-end processes (creation, review, approval, change control).
• Enable efficient cross-functional workflows that minimize cycle time while ensuring compliance.
• Establish version control, audit trails, and documentation to support inspection readiness.
• Oversee mock-ups and concept artwork for regulatory and internal use.

Safety & Time-Critical Labeling Updates

• Build lean, rapid-response processes for safety-driven labeling updates.
• Ensure accelerated execution while maintaining full compliance.
• Coordinate with Regulatory, Pharmacovigilance, and Manufacturing to support timely multi-country implementation.

Packaging & External Manufacturing Integration

• Partner with External Manufacturing and CMOs to ensure artwork is production-ready.
• Align artwork processes with packaging operations, supply timelines, and launch readiness.
• Provide oversight to artwork vendors and packaging partners to ensure quality and consistency.

Compliance, Quality & Continuous Improvement

• Establish and maintain GMP-compliant SOPs, policies, and workflows.
• Ensure all activities are inspection-ready and aligned with global expectations.
• Drive improvements in cycle time, right-first-time performance, and process simplicity.

Leadership & Performance Management

• Act as the artwork and labeling SME across Regulatory, Quality, Supply Chain, and Commercial.
• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery).
• Manage budget and vendors with a focus on cost-effective, scalable solutions.

Qualifications

Required Experience

• Bachelor’s degree preferred
• 10+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment
• Demonstrated experience building artwork intake, triage, and tracking processes in fast-paced environments
• Track record of success implementing end-to-end artwork lifecycle management
• Proven success in managing time-critical labeling and safety updates and selecting and deploying validated AMS platforms

Leadership Capabilities

• Proven ability to build scalable processes from the ground up
• Strong stakeholder management and decision-making skills
• Ability to simplify complexity and drive execution in resource-constrained settings
  
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Job purpose

As a Manager, External Manufacturing and Supply Operations, you are responsible for the end-to-end technical and operational oversight of external manufacturing and supply activities across a network of Contract Manufacturing Organizations (CMOs). This role sits at the core of Manufacturing and External Supply Operations and requires a strong technical foundation, the ability to manage multiple concurrent priorities, and to operate effectively in a fast-paced, ambiguous environment.

This position places particular emphasis on batch record review and approval, process oversight, and technical decision-making, ensuring that manufacturing activities are executed in full compliance with cGMP standards and aligned with global supply requirements.

You will collaborate cross-functionally with Quality Assurance, Technical Operations, Regulatory Affairs, and Supply Chain to ensure robust, compliant, and reliable supply for both clinical and commercial products. You will report to the Director, External Supply Operations.

Responsibilities

• Build and maintain strong, technically credible relationships with external CMOs and internal cross-functional stakeholders
• Provide hands-on technical oversight of manufacturing operations at CMOs, ensuring adherence to validated processes, regulatory expectations, and internal standards
• Own and lead the review and approval of batch records, ensuring accuracy, completeness, and compliance with cGMP and product specifications
• Act as the technical authority for batch disposition readiness and support, identifying and resolving issues that may impact product quality or release timelines
• Ensure prompt execution of manufacturing and supply plans, proactively identifying risks and implementing mitigation strategies
• Drive investigation and resolution of deviations, OOS/OOT events, and product complaints, including leading or supporting root cause analysis (RCA) and CAPA development
• Provide technical input and oversight for change controls, ensuring appropriate impact assessments and alignment with regulatory filings and process validation state
• Develop and support deep understanding of manufacturing processes (API, Drug Product, and Packaging) to enable effective troubleshooting and continuous improvement
• Review and approve technical documentation, including but not limited to:
  
  
  • Batch manufacturing and packaging records
  • Specifications and master data
  • Validation protocols and reports (IQ/OQ/PQ)
  • Stability protocols and reports
  • Change controls and deviations
    
    
• Support process validation and ongoing process verification, ensuring continued state of control at CMOs
• Play a key role in technology transfers, process scale-up, and site onboarding, ensuring technical robustness and successful execution
• Partner with Quality and CMO teams to monitor batch execution in real time, ensuring proactive issue identification and resolution
• Ensure effective management of BOMs, master data, and ERP/MRP systems to support accurate production planning and execution
• Lead or participate in routine governance and operational meetings with CMOs, driving accountability and performance improvements
• Support regulatory submissions and CMC activities, ensuring technical accuracy and consistency with manufacturing processes
• Maintain oversight of inventory, production schedules, and supply continuity, ensuring alignment with demand and minimizing supply risk
• Drive a continuous improvement culture, identifying opportunities to enhance process robustness, reduce deviations, and improve right-first-time performance

Qualifications

Education & Core Experience

• BS/BA Degree in Life Sciences, Engineering, or related discipline desirable
• 10+ years’ experience across pharmaceutical manufacturing, technical operations, or external supply in a regulated environment
• Strong cGMP manufacturing experience within a pharmaceutical plant environment, with direct exposure to shop-floor operations and batch execution
• Demonstrated expertise in batch record review and approval, with a deep understanding of critical process parameters, in-process controls, and data integrity
• Proven experience working with external CMOs, providing technical oversight and driving performance in outsourced manufacturing environments
• Strong technical knowledge across Drug Product, API, and Packaging operations, with the ability to troubleshoot complex manufacturing issues
• Hands-on experience in deviation management, investigations (OOS/OOT), and CAPA implementation
• Solid understanding of process validation, lifecycle management, and continued process verification
• Experience supporting or leading technology transfers and process scale-up activities
• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH, EU GMP)
• Experience with ERP/MRP systems and manufacturing data structures (BOMs, master data)
• Proven ability to apply risk management principles and make sound technical decisions under pressure
• Excellent communication skills, with the ability to clearly articulate complex technical issues to diverse stakeholders
• Ability to operate effectively in a fast-paced, high-growth environment, managing multiple priorities simultaneously
• Willingness to travel (~25%) to support CMO oversight and on-site technical activities
  
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As Associate Director, Sourcing & Supplier Relationship Management, you will play a critical role in ensuring the suppliers and partners we work with meet our high standards for quality, innovation, and patient impact. This role plays a critical part in the comprehensive lifecycle of Cytokinetics relations with partners and suppliers supporting Global Supply Chain & Technical Operations. This role requires strong strategic thinking, broad industry experience and excellent relationship development and management skills. This role will support our Sourcing and Network Strategy pillar, a key component of our Global Supply Chain & Technical Operations strategy.  This role will support our Manufacturing and Lab Services Supplier Strategy, marketplace assessments of supplier capabilities from early development thru post approval Commercialization, supplier due diligence through Request for Information (RFI) and Requests for Proposals (RPF). These due diligence activities will lead to collaborative supplier selection, contract negotiations, operationalization of the relationship and ultimately management of supplier performance against the contract. This role will be a key partner to CMC and Technical Operations, External Manufacturing and Supply Operations, Enterprise Risk Management, Supply Planning and Partner Pillar activities, and the Supply Chain Center of Excellence in Dublin Ireland. This role requires demonstrated business acumen, influencing skills, strategic thinking, relationship building and collaboration behaviors.

Responsibilities

Strategic Supplier Management

• Develop and execute sourcing and network strategies that align with Global Supply Chain & Technical Operations goals.
• Serve as the primary commercial point of contact for assigned CMOs, Labs and critical suppliers.
• Conduct marketplace assessments, supplier segmentation, and due diligence (RFIs/RFPs).
• Collaborate with Enterprise Risk Management to identify and mitigate supplier sourcing risks.

Contracting & Negotiations

• Lead supplier selection, contract negotiations, and agreement development in partnership with Legal, Finance, Procurement, and Quality.
• Support External Supply team with contract setup, budget planning, and tracking.

Performance & Risk Management

• Monitor supplier performance using standard KPIs and ensure compliance with contractual and regulatory requirements.
• Support supplier audits and develop business continuity and risk management processes.
• Identify opportunities to improve supplier value, cost, quality, and service.

Collaboration & Leadership

• Partner with CMC, Technical Operations, Supply Planning, and global teams in Dublin, Ireland.
• Represent Supply Chain Sourcing on cross-functional teams for complex projects.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or related field (advanced degree a plus).
• 10+ years of experience in Life Sciences, Engineering, Business, or Supply Chain, preferably within Biotech/Pharma.
• Strong understanding of product development, GMP manufacturing, and related regulations (cGMP, GCP, CFRs, Part 11, FDA/EMA Guidelines).
• Proven expertise in manufacturing cost benchmarks and pricing strategies for small molecule manufacturing.
• Demonstrated success in supplier relationship management, contract negotiation, and strategic sourcing.
• Strong communication, collaboration, and influencing skills.
• ERP systems experience, preferably Oracle
• Ability to travel domestically and internationally (15–20%).

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Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. 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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

We are currently seeking a Senior Manager, Supply Chain and Technical Project Management in our Global Supply Chain & Technical Operations department. 

This position is integral to the advancement of Cytokinetics’ growing portfolio of drug candidates and technology programs and will coordinate cross-functionally to ensure project deliverables are met on-time, on-budget, and with a high degree of quality.

Reporting to the Director of Portfolio Management within Global Supply Chain & Technical Operations, this role will be responsible for the creation, and management of timelines, and deliverables to support the technical development, validation, and commercialization of drug substances, formulated drug product and packaging using Cytokinetics internal resources and an external network of providers. 

Responsibilities

• Provide project management support at any stage of the drug development lifecycle (e.g., early to late-stage development, market authorization, or post-launch phases)
• Develop charters, integrated schedules, deliverable lists, status updates, resource requests and related communications for assigned projects and programs
• Maintain a positive, results-oriented work environment by building partnerships, modeling collaboration and communicating in an open, balanced and objective manner to enable a high-performing team
• Proactively monitor timelines, KPIs, critical path, and resources for assigned projects using appropriate tools, project management principles and practices to deliver project objectives
• Work cross-functionally to coordinate interdependencies with other projects. Resolve and/or escalate conflicts and issues to remove barriers to project success
• Leverage risk management tools and techniques to proactively identify, mitigate and manage risks throughout the project lifecycle to avoid deviations to the project goals and objectives
• Engage sponsors, functional senior leadership, and key stakeholders in regular and meaningful project communications (dashboards, reports, metrics, etc.) to ensure delivery of expected business outcomes
• Lead and/or support continuous improvement of processes and tools
• 10-20% Travel, as necessary according to project needs

Qualifications

• BA/BS in Scientific, Technical, Engineering or Business discipline (advanced degree preferred)
• A minimum of 10 years total work experience, with at least 5 or more years relevant experience in project management within the life sciences (pharmaceutical / biotech / medical device) industry
• Sound technical knowledge in one or more of the following categories: Chemical Development, Formulation Development, Clinical, Manufacturing, Analytical, Packaging, Serialization, Planning, or Logistics (small molecule drug development is a plus)
• Outstanding project management, planning, organization, prioritization, and time management skills
• Ability to adapt to changing situations, and effectively manage multiple projects and priorities
• Ability to think creatively in order to provide non-standard solutions
• Strong partnering skills – ability to thoughtfully cultivate strong and highly effective working relationships with internal and/or external customers and stakeholders
• Strong influencing, organizational and interpersonal skills – consistently achieves targeted results without authority by leveraging expertise, business knowledge, and partnerships
• Project Management Professional (PMP) Certification preferred
• Six Sigma or other Operational Excellence related certifications is a plus
  
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