GxP Training & Quality Systems Lead

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytokinetics, Inc. is seeking a Manager of GxP Training, Quality Systems to lead the administration, development, and continuous improvement of the GxP training program.

You will manage day-to-day GxP training activities, maintain curricula and materials, and ensure compliance with regulatory requirements across multiple delivery formats. Reporting to the Senior Manager, Quality Systems, GxP Training, you will contribute to the broader GxP training strategy, support inspections, audits, and

Qualifications

• Bachelor’s degree in life sciences, business, education, communications, technical writing, or a related field, or an equivalent combination of education and relevant experience.
• 6+ years of combined experience in GxP Training, Document Control, Quality Systems, or related functions in the biotechnology or pharmaceutical industry.
• 2+ years of recent experience administering Veeva Vault Training.
• Working knowledge of GxP regulations, quality systems, and GxP training compliance requirements.
• Strong technical writing, presentation, and facilitation skills, with the ability to communicate complex information clearly and accurately.
• Strong project management, communication, and stakeholder management skills.
• Excellent organizational skills, with strong attention to detail and ability to manage multiple priorities and work effectively in a fast-paced environment.
• Able to develop engaging and compliant training, as well as delivering training to employees at all levels of an organization.
• Demonstrated curiosity and interest in continuous learning, with the ability to research and evaluate relevant industry trends and evolving best practices and apply or recommend them, as appropriate.
• Experience supporting regulatory inspections, internal audits, and customer audits.
• Experience monitoring training metrics, contributing to continuous improvement initiatives, and inspection readiness.

Responsibilities

• Execute assigned goals and initiatives that advance the continuous improvement of GxP training processes, standards, and business practices.
• Ensure GxP functional roles and associated curricula are appropriately targeted, relevant, and routinely reviewed for accuracy and compliance.
• Create, review, and refine GxP functional training assignments, learner roles, and curricula, and recommend opportunities for improvement to the Senior Manager.
• Develop or contribute to clear and effective GxP training materials using instructor-led, virtual, and eLearning formats, as appropriate.
• Collaborate with GxP and non-GxP departments to align training objectives and activities where responsibilities overlap.
• Monitor open GxP training assignments, coordinate follow-up activities, and report training metrics.
• Exercise judgment when interpreting existing procedures and administering the GxP LMS and associated training processes within established procedures and delegated authority.
• Partner with IT and business stakeholders to ensure training systems support user and organizational needs.
• Collaborate with Document Control to promote effective integration and consistent user experience across the EDMS and LMS.
• Support inspections, audits, and responses to training-related observations or requests.
• Manage assigned projects and deliverables based on established timelines and priorities.
• Ensure training processes remain inspection-ready and compliant with applicable FDA, EMA, ICH, and other GxP regulatory requirements.
• Provide Document Control coverage, as needed.

Skills

GxP training

Project management

Regulatory knowledge

Technical writing

Stakeholder management

Communication skills

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva Vault Training

Articulate 360

Camtasia

Job description

Cytokinetics, Inc. is seeking a Manager of GxP Training, Quality Systems to lead the administration, development, and continuous improvement of the GxP training program.

You will manage day-to-day GxP training activities, maintain curricula and materials, and ensure compliance with regulatory requirements across multiple delivery formats. Reporting to the Senior Manager, Quality Systems, GxP Training, you will contribute to the broader GxP training strategy, support inspections, audits, and