Quality Training Manager at Vaxcyte, Inc.
San Carlos, CA
About the Job
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for a Quality Training Manager, who will be responsible for developing, implementing, and maintaining the quality training program for the organization. The Quality Training Manager works closely with the Quality Assurance and operations teams to ensure that regulatory standards and expectations are met. The Quality Training Senior Specialist is also responsible for ensuring that training compliance requirements are fulfilled and documented.
Essential Functions:
Requirements:
Reports to: Director, Document Control
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $155,000 – $166,000
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for a Quality Training Manager, who will be responsible for developing, implementing, and maintaining the quality training program for the organization. The Quality Training Manager works closely with the Quality Assurance and operations teams to ensure that regulatory standards and expectations are met. The Quality Training Senior Specialist is also responsible for ensuring that training compliance requirements are fulfilled and documented.
Essential Functions:
- Ensure that the training compliance requirements are fulfilled and documented according to the applicable standards and regulations.
- Work with departmental representatives to manage a role-based quality training program for new hires, existing employees, and contractors.
- Assess the training needs and gaps of the organization and provide recommendations for improvement.
- Manage Training Requirements, Curricula, Learner Roles, and Person records in the Veeva Vault Training LMS.
- Monitor and evaluate the effectiveness and impact of the quality training program and provide feedback and reports including reporting on training compliance metrics and indicators.
- Coordinate and collaborate with management to align the quality training programs with the organizational goals and objectives.
- SME for Training during audits or inspections.
- Stay updated on the latest trends and best practices in quality training and development.
Requirements:
- Bachelor’s BA/BS degree or equivalent experience.
- At least 5 years of experience in quality training, quality assurance, or quality management.
- Experience with Veeva Vault Training or similar LMS platforms.
- Strong knowledge and skills in GxP quality standards, methodologies, and tools.
- Understanding of current regulatory expectations including 21CFR Part 11 requirements.
- Excellent communication, presentation, and facilitation skills.
- Ability to analyze and evaluate the quality training needs and outcomes.
- Ability to work independently and collaboratively with cross-functional teams.
- Proficient in Microsoft Office and SmartSheet.
- Ability to meet deadlines and multi-task efficiently.
- Strong attention to detail, organizational skills, ability to work in a faced paced environment.
Reports to: Director, Document Control
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $155,000 – $166,000