1 день назад
Quality Systems And Compliance
152 000 - 190 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Systems And Compliance (GxP/Clinical Development): Designing and implementing a Quality Management System for clinical development programs and a growing drug pipeline with an accent on regulatory compliance, inspection readiness, and scalable quality operations. Focus on managing CAPA, deviations, investigations, change controls, risk assessments, eQMS, and internal and third-party audits across U.S. and global clinical programs.
Location: Remote in the United States or hybrid at the San Diego headquarters
Compensation: $152,000–$190,000 per year
Company
is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.
What you will do
- Execute and support the ongoing effectiveness of the Quality Management System.
- Manage deviations, investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks with internal teams and external partners.
- Create controlled documents and governance frameworks for core quality processes and continuous improvement.
- Translate regulatory and quality requirements into practical, scalable operating models.
- Monitor compliance risks through data-driven quality oversight and coordinate internal and third-party audits.
- Prepare U.S.-based and global clinical programs for regulatory inspections through quality systems and cross-functional alignment.
Requirements
- Bachelor’s degree in a scientific or technical field such as biology, chemistry, engineering, or health science.
- 6+ years of progressive Quality experience in a GxP-regulated industry.
- Experience implementing or improving a Quality Management System and maintaining electronic QMS platforms such as Veeva, ZenQMS, or MasterControl.
- Experience supporting inspection readiness, audits, or regulatory interactions.
- Working knowledge of GCP and applicable GMP principles, global regulatory expectations, risk-based quality systems, and continuous improvement.
- Experience leading cross-functional collaboration with Regulatory, CMC, Clinical Operations, Information Technology, and R&D teams.
Culture & Benefits
- Inclusive environment focused on collaboration across diverse backgrounds and disciplines.
- Company-paid healthcare and flexible spending accounts.
- Voluntary life insurance and 401(k) matching.
- Uncapped vacation.
- Access to an onsite gym and dining at the San Diego facility.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →