Manager Quality Systems - GxP Training

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.

The Manager of GxP Training, Quality Systems supports the administration, development, and continuous improvement of the company’s 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 company’s broader GxP training strategy.

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 & 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.
  
  

Preferred Experience

• 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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer