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3 месяца назад

Associate Director / Director, Analytical Science & Quality Control

Формат работы
onsite
Тип работы
fulltime
Грейд
senior/lead
Английский
c1
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
Associate Director / Director, Analytical Science & Quality Control (Medical): Lead and manage analytical development and quality control activities for drug substances and products from early development through commercial support with an accent on cGMP compliance, vendor management, and regulatory documentation. Focus on developing and validating analytical methods, stability testing, and ensuring quality oversight for the China market including on-site supervision.

Location: Shanghai, China (onsite role)

Company

hirify.global is a biopharmaceutical company focused on developing novel oncology therapeutics to improve quality of life and survival for cancer patients.

What you will do

  • Lead analytical development and quality control testing across drug substance and product lifecycle phases.
  • Manage third-party CRO/CDMO vendors and ensure alignment with global analytical strategies.
  • Oversee quality control for commercial manufacturing and release testing in China, including on-site supervision.
  • Develop and maintain policies, SOPs, and regulatory documentation for analytical activities.
  • Coordinate cross-functional collaboration with internal teams and external partners globally.
  • Lead inspections and audits of vendor sites from an analytical and quality control perspective.

Requirements

  • Location: Must be based in Shanghai, China with onsite presence
  • Bilingual proficiency in Chinese and English (reading, writing, speaking, listening) required
  • 10+ years pharmaceutical industry experience with strong analytical chemistry background.
  • Working knowledge of cGMP regulations and compendial standards (USP, EP, JP, ChP).
  • Experience managing CRO/CDMO relationships and cross-functional teams.
  • Strong problem-solving, communication, and independent working skills in a fast-paced environment.

Culture & Benefits

  • Competitive base salary, bonus, and equity plans.
  • Up to 15 optional and 12 sick days annually.
  • Excellent medical coverage and social security benefits.
  • Supportive work environment emphasizing ownership, accountability, and adaptability.

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