3 дня назад
Senior Manager QA Auditor (GCP Strategy)
86 800 - 141 200$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager QA Auditor (GCP Strategy) (Global Development Quality Assurance): Leading risk-based GCP audit planning and compliance programs across therapeutic areas and studies with an accent on regulatory alignment, audit outcomes, and cross-functional quality oversight. Focus on identifying risk trends, supporting regulatory inspections, and delivering strategic reports and metrics to senior leadership.
Location: Remote in the UK or Ireland; 10–20% travel may be required.
Salary: $86,800–$141,200 annually.
Company
is a science-driven biotechnology company developing medicines for people with serious diseases.
What you will do
- Lead risk-based audit planning across therapeutic areas and clinical studies.
- Drive strategic audit programs using risk indicators from study teams.
- Ensure audits align with approved programs and scheduled timelines.
- Manage audit outcomes, identify trends, and communicate quality risks.
- Represent quality assurance in complex cross-functional initiatives.
- Deliver audit reports and metrics to Global Development leadership.
Requirements
- Bachelor’s degree and 8+ years of relevant industry experience.
- 5+ years of GCP audit strategy or audit experience.
- Knowledge of FDA, EU, and ICH GCP regulations and guidance.
- Experience supporting or participating in regulatory inspections.
- Strong project management and stakeholder management capabilities.
- Excellent written and verbal communication skills with senior audiences.
Culture & Benefits
- Remote work arrangement for the UK or Ireland.
- Inclusive workplace with reasonable accommodations available during recruitment where required.
- Potential benefits include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Background checks may verify identity, right to work, and educational qualifications in accordance with local law.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
4 дня назад
Senior GCP Auditor (Biotech)
140 000 - 154 000$
5 дней назад
Principal Scientist, Project Toxicologist (Biotech)
152 224 - 205 951$
9 дней назад
Pharmacovigilance Quality Assurance Manager
102 000 - 177 100$
4 дня назад
Sr Staff Medical Affairs Specialist (Genomics)
155 600 - 233 400$
9 дней назад
Pharmacovigilance QA Auditor Specialist
79 000 - 127 650$
9 дней назад
Imaging Specialist Manager (Clinical Trials)
98 125 - 132 757$