2 дня назад
M&S - Quality Assurance Head - IFB
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
M&S - Quality Assurance Head - IFB (Pharmaceutical Manufacturing): Leading quality assurance activities for a new automated insulin drug substance facility in Beijing with an accent on GMP compliance, quality systems, and qualification and validation strategies. Focus on developing risk-based quality processes, supporting DQ, SAT, FAT, IQ, OQ, and nP-PQ activities, and coordinating audits and regulatory inspections.
Location: Beijing, China
Company
is developing a large, automated biologics facility for insulin drug substance manufacturing in Beijing.
What you will do
- Lead Quality Assurance activities across the project and future site organizations, ensuring GMP compliance and continuous improvement.
- Act as the Quality Assurance subject matter expert and lead the development and implementation of Quality Management Systems and quality risk management.
- Develop, review, and release quality documentation in line with project plans, standards, local regulations, and applicable requirements.
- Support C&Q&V strategy execution, including DQ, SAT, FAT, IQ, OQ, nP-PQ protocols, final reports, and the Validation Master Plan.
- Coordinate quality reporting, issue escalation, inspection preparation, audit participation, and post-inspection follow-up.
- Mentor project team members, promote quality behaviors, support risk-based decisions, and contribute to safety training and digital transformation.
Requirements
- Bachelor’s degree in Science, Pharmacy, or an equivalent field; a Master’s degree in Science is preferred.
- 5–8 years of experience in the biopharmaceutical or another regulated industry, including practical Quality Assurance experience.
- Knowledge of biologic product license application processes, regulatory requirements, pharmaceutical manufacturing, automation, scientific writing, and risk analysis.
- Expertise in Quality Operations, Quality Systems, Quality Risk Management, GxP, and regulated-industry requirements.
- Fluent written and spoken Chinese and English are required.
- Strong change management, cross-functional collaboration, decision-making, negotiation, influencing, and people development skills.
Culture & Benefits
- Supportive, future-focused environment centered on scientific innovation.
- Opportunities for career growth through promotions, lateral moves, and international opportunities.
- Rewards package designed to recognize contribution and impact.
- Healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
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