7 дней назад
Quality Compliance Manager (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Compliance Manager (Pharmaceutical): Developing and maintaining compliance programs, quality risk management systems, and business-owned quality processes for a pharmaceutical site with an accent on regulatory inspections, risk assessment, and quality documentation. Focus on deciding risk mitigation and corrective actions, leading continuous improvement, and managing compliance and quality risk activities in coordination with global teams.
Location: Beijing, China; onsite
Company
develops medicines and healthcare solutions and operates within the pharmaceutical industry.
What you will do
- Develop, implement, and maintain an effective site compliance program aligned with pharmaceutical laws, regulations, standards, and global requirements.
- Coordinate regulatory inspections and internal or external audits, including preparation of documentation, responses, remediation, and corrective actions.
- Establish and maintain quality risk management processes, including risk assessments, risk matrices, risk libraries, metrics, and periodic reviews.
- Own designated quality processes, systems, and data; perform data quality checks, validations, and KPI monitoring.
- Lead quality alerts, batch recall processes, continuous improvement initiatives, and computerized system oversight.
- Lead and develop the compliance team through hiring, training, coaching, professional development, and performance evaluation.
Requirements
- Experience managing compliance and quality risk activities in a pharmaceutical or health-regulated environment.
- Ability to interpret and apply applicable laws, regulations, standards, and global quality processes.
- Experience supporting regulatory inspections, audits, risk assessments, investigations, remediation, and corrective actions.
- Ability to manage quality processes, computerized systems, data checks, validations, and performance indicators.
- Ability to lead training, facilitate risk assessments, collaborate across functions, and communicate with global teams and health authorities.
- Role is based onsite in Beijing, China.
Culture & Benefits
- Work within a global pharmaceutical organization and collaborate with international quality and compliance teams.
- Participate in global quality risk management and process communities of practice.
- Support an inclusive workplace with equal employment opportunities.
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 →