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M&S Graduate Program-Quality Lead-Beijing

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
China
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
M&S Graduate Program-Quality Lead-Beijing (Pharmaceutical Quality Control): Supporting analytical testing, QC laboratory operations, regulatory compliance, and continuous improvement for sterile and non-sterile pharmaceutical manufacturing with an accent on GMP, data integrity, investigations, and quality systems. Focus on building inspection readiness, developing contamination control and sterility assurance systems, collaborating across manufacturing functions, and progressively taking on people leadership responsibilities.

Location: Beijing, China

Company

R&D-driven biopharmaceutical company developing medicines and vaccines, with a focus on digital transformation, AI-enabled manufacturing, and sustainable global supply.

What you will do

  • Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, and stability samples according to SOPs, GxP, and regulatory requirements.
  • Support QC equipment qualification, calibration, preventive maintenance, analytical method verification, and validation activities.
  • Document results according to data integrity standards and participate in deviation investigations, root cause analysis, and CAPA follow-up.
  • Support inspection readiness, self-audits, global audits, and regulatory inspections involving NMPA, FDA, and EMEA requirements.
  • Contribute to contamination control, sterility assurance, laboratory safety, 5S, trend analysis, and continuous improvement initiatives.
  • Collaborate with Production, Quality Assurance, Regulatory Affairs, Engineering, and Supply Chain while developing QC team members and progressively taking on people management responsibilities.

Requirements

  • Master’s degree in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Life Sciences, or a related technical discipline; a top MBA with relevant manufacturing exposure may also be considered.
  • At least 2–3 years of experience in pharmaceutical quality assurance, quality control, manufacturing, or related regulatory and compliance roles, ideally in a GMP-regulated environment.
  • Practical exposure to cGMP operations, deviations, OOS investigations, CAPA, and regulatory compliance.
  • Knowledge of biologic product license application processes, quality systems, quality risk management, continuous improvement, GxP, and health-regulated requirements.
  • Fluency in English is required, with strong written and verbal communication skills for regulatory documentation and cross-functional collaboration.
  • LEAN-oriented problem solving, openness to learning new tools, and the ability to collaborate effectively across the organization.

Nice to have

  • Experience or strong interest in sterile manufacturing, contamination control, or biologics quality systems.
  • Familiarity with Chinese cGMP, FDA, or EMEA regulatory frameworks.
  • Experience with the KNEAT solution.
  • Strong interest in Digital & AI-enabled manufacturing and supply chain solutions.

Culture & Benefits

  • Structured 3-year leadership accelerator with defined rotations, milestones, and a guaranteed landing role.
  • Cross-regional and cross-functional immersion in live manufacturing and supply operations.
  • Mentorship from a Site Head and Global M&S Leader, with regular access to business leaders.
  • Personalized career roadmap, external professional coaching, and capability building in Digital & AI, critical thinking, and leading change.
  • Opportunities to contribute to smart factories, AI-driven supply chain solutions, new product launches, sustainability, and low-carbon manufacturing.

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