2 дня назад
M&S-China EM&S Quality Regulatory Manager (Pharmaceutical Quality)
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-China EM&S Quality Regulatory Manager (Pharmaceutical Quality) (GMP/Regulatory Compliance): Establishing and maintaining quality management systems for contract-manufactured pharmaceutical products in China with an accent on regulatory compliance, sterile drug production, supplier oversight, and post-marketing change control. Focus on coordinating inspections and audits, managing CAPA and quality agreements, reviewing packaging artwork, and making quality decisions that protect patient safety.
Location: Shanghai, China; onsite
Company
is a global healthcare company developing medicines and applying science to improve patients’ lives.
What you will do
- Establish and maintain the quality management system for contract manufacturing, including self-inspections, quality reviews, metrics, risk communication, and continuous improvement.
- Manage local product regulatory status, licenses, GMP certifications, annual product quality reports, annual drug reports, and submissions to health authorities.
- Coordinate regulatory inspections and external audits, and ensure timely implementation and closure of CAPA plans.
- Maintain change control, post-marketing change management, regulatory databases, departmental SOPs, training matrices, and annual GMP training.
- Review packaging artwork and coordinate regulatory changes with cross-functional teams.
- Manage suppliers and materials, perform contract manufacturing oversight, conduct in-plant supervision, and evaluate CMO quality systems and quality assurance agreements quarterly.
Requirements
- Master’s degree or higher in Pharmacy, Chemistry, Biology, Biochemistry, or a related field.
- At least 5 years of practical experience in pharmaceutical production and quality management, including at least 3 years in sterile drug production and quality management.
- Knowledge of GMP regulations including NMPA and EMA, ICH guidelines, the MAH system, biological product quality and production management, quality control, and pharmaceutical manufacturing processes.
- Strong inspection management, analytical, problem-solving, judgment, decision-making, communication, and coordination skills.
- Good English skills and the ability to work across functions and organizations.
- Ability to work onsite in Shanghai, China.
Nice to have
- Experience operating within the MAH system.
Culture & Benefits
- Supportive, future-focused environment with opportunities for professional growth and international career development.
- Rewards package recognizing individual contribution.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Equal-opportunity workplace supporting people from diverse backgrounds.
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