12 часов назад
Manager/Sr. Manager, Training, Quality Systems (GxP)
125 000 - 165 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager/Sr. Manager, Training, Quality Systems (GxP): Managing the GxP training program, eLMS administration, role-based curricula, onboarding, training content, and compliance reporting with an accent on quality systems, instructional design, and regulatory inspection support. Focus on designing compliant training architectures, improving digital learning resources, monitoring department-wide training compliance, and supporting audits and quality management reviews.
Location: San Carlos, California, United States; onsite
Salary: $125,000–$165,000 per year
Company
is a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune disorders, and other serious diseases.
What you will do
- Manage the GxP training program and administer the electronic Learning Management System.
- Create and revise role-based training curricula, SOPs, work instructions, training materials, and digital learning resources.
- Manage Quality onboarding, employee curricula assignments, LMS user support, and live or digital GxP training.
- Monitor training compliance, publish reports, escalate issues, and develop training metrics and quality management review content.
- Support LMS upgrades, change management, quality systems, document control activities, audits, and regulatory inspections.
- Oversee training-related employee resumes, CVs, job descriptions, and periodic GxP refresher training.
Requirements
- At least 5 years of experience in a GxP environment, preferably in Document Control or Quality Systems, including at least 2 years working with GxP training.
- Bachelor’s degree in a related field preferred.
- Experience administering electronic learning management systems and training programs in the life sciences or another highly regulated industry.
- Experience with electronic document and quality management systems.
- Knowledge of GxP and Quality Systems principles under US, EU, and other relevant regulatory guidance.
- Strong organization, communication, instructional design, facilitation, cross-functional collaboration, and MS Office skills.
Nice to have
- Experience supporting the transition from a development organization to a commercial organization.
- Experience with regulatory inspections.
Culture & Benefits
- Competitive cash compensation, equity incentive awards, and employer-sponsored benefits.
- Work onsite in San Carlos, California.
- Collaborate cross-functionally with subject matter experts and Quality teams.
- Support continuous improvement of training programs, LMS capabilities, content, and Quality Systems.
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