Manager, Quality Systems GxP Training (Contract)

Cytokineticsis 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.

The Manager of GxP Training Quality Systems supports the administration development and continuous improvement of the companys GxP training program. This role manages and executes assigned day-to-day GxP training activities ensuring that training assignments curricula systems and learning materials remain accurate effective and aligned with regulatory requirements business needs and established departmental priorities.

As a GxP Training subject matter expert the Manager contributes to the development and implementation of learning initiatives across multiple delivery methods including instructor-led training virtual training eLearning and system-based training.

This position reports to the Senior Manager Quality Systems GxP Training and supports the execution of the companys broader GxP training strategy.

• 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.

• Bachelors 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.
  
  

• Education certification or practical experience in instructional design adult learning learning and development or related discipline.
• Familiarity with eLearning and video-based training tools such as Articulate 360 Camtasia or similar authoring platforms.
• Experience translating regulatory requirements and technical concepts into practical learner-focused training materials.
  
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Pay Range:

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.

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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.

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Cytokinetics is an Equal Opportunity Employer