POSITION SUMMARY

The primary role of the Manager GXP Training will be to manage the development, implementation, and sustainability of quality and companywide training programs. This position will ensure employees and contract staff meet compliance requirements relating to knowledge, skill, and practices necessary for their job performance and remain prepared to perform assigned tasks. This position will manage the Veeva Vault learning management system in support of all training initiatives within the organization. This position reports to the VP of Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for development and execution the training
• Work directly with all levels and departments at CymaBay to establish training curriculums and assignments based on assigned functions

• Evaluate GXP training needs and participate in developing and delivering training materials, utilizing high-quality, innovative, timely, and effective learning solutions

• Process and maintain current learning management processes and training records for compliance

• Manage the Veeva Vault learning management system in conjunction with CymaBay IT Team

• Work with Document Control and other functional departments to coordinate training on new or revised procedures

• Provide guidance and information to leadership on recommended training programs, curricula, training material development, and learning assignments

• Support inspections and audits

• Build and run training compliance metrics. Leverage metrics to measure the effectiveness of training programs, and actively seek ways to drive enthusiasm for learning and training.
• Manage projects and training initiatives directly supporting GXP initiatives to effectively implement strategic business objectives in driving quality and compliance
• Support Quality Department Leadership vision and assist with developing our evolving LMS platform strategy.
• Create and manage standard and custom reports from the learning platform.
• Maintain and implement GxP training policies and procedures.
• Partner with Commercial Training leadership to ensure that the GxP training strategy and delivery is aligned. Actively collaborate and present solutions to deliver a seamless learning experience for CymaBay employees as the GxP training lead.
• As the Veeva Vault Training expert, coach team members on the development of course curriculum, and learning content.
• Oversee the development and delivery of training (i.e. face-to-face, e-learning, webinars, etc.).
• Facilitate and oversee a range of learning opportunities to ensure employees across the organization have the skills needed to be effective, qualified and compliant in their roles/functions
• Acts as the Veeva Vault Training business system owner to support ongoing validation, implementation, and system configuration changes, inclusive of testing new functionality and content within the learning platform.
• Partner with functional area manager to ensure applicable training curriculum is defined, in place and assigned to new/existing personnel.
• Partner with CymaBay Department Heads to ensure continued system growth through creation or acquisition of relevant training content (e.g. identify and purchase content from Third Party)
• Complete other responsibilities, as assigned

MINIMUM QUALIFICATIONS

• Minimum 5-7 years of relevant experience in with GXP training
• Biotech/pharmaceutical/GXP industry or expertise in a highly regulated environment is strongly preferred
• Extensive knowledge of SOPs and GXPs and the know-how to work and manage within a regulated environment
• Prior experience with eLMS systems (e.g., Veeva or ComplianceWire)
• Strong change management skills and demonstrated ability to simplify and improve business processes
• Adaptable to a fast-paced, complex, and ever-changing business environment
• Practical verbal and written communications skills
• Solid organizational skills and attention to detail
• Self-motivated, self-disciplined, and able to function independently and as part of a team
• Excellent computer proficiency (MS Word, Excel, PowerPoint)

EDUCATION, CERTIFICATES, LICENSES, REGISTRATIONS

• Bachelor of Science degree

The anticipated salary range for the Manager, GXP Training, who will work in Newark, California is $140,000 - $165,.000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.

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