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8 часов назад

M&S Quality Services, Third Party Audits Manager - KL Hub (Pharmaceutical Quality)

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Malaysia
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 Quality Services, Third Party Audits Manager - KL Hub (Pharmaceutical Quality): Planning and executing GxP audits of third-party manufacturers and contract manufacturing organizations with an accent on cGMP compliance, regulatory assessment, and CAPA follow-up. Focus on leading supplier audit programs, supporting root cause investigations, monitoring FDA and EMA requirements, and maintaining inspection readiness.

Location: Kuala Lumpur / Petaling Jaya, Malaysia

Company

hirify.global is a global pharmaceutical company focused on developing and delivering medicines and improving patient outcomes.

What you will do

  • Plan, organize, and conduct GxP quality audits of third-party manufacturers and contract manufacturing organizations.
  • Assess supplier compliance with material, regulatory, corporate, divisional, and country-specific quality requirements.
  • Identify quality gaps, communicate audit findings, and follow CAPAs through closure.
  • Act as the quality interface between suppliers, internal sites, affiliates, and global quality teams.
  • Lead the quality compliance team, coach auditors, assess training needs, and support auditor qualification.
  • Monitor FDA and EMA requirements, support root cause analyses and quality risk management, and improve audit processes.

Requirements

  • Experience in quality auditing within pharmaceutical, biotech, or regulated manufacturing environments.
  • Hands-on experience with GxP/cGMP audits of third-party manufacturers or contract manufacturing organizations.
  • Strong knowledge of FDA, EMA, and applicable regional health authority requirements.
  • Ability to plan and report on-site and remote audits, identify compliance gaps, and drive RCA and CAPA follow-up.
  • Scientific, engineering, pharmaceutical, or related quality degree.
  • Fluency in English is required.

Nice to have

  • Proficiency in Mandarin or Japanese for the relevant region or markets.
  • Experience with sophisticated or for-cause audits and inspection preparedness.

Culture & Benefits

  • Work with global quality professionals and cross-functional stakeholders in an international environment.
  • Mentor new auditors and engage with complex quality and regulatory topics.
  • Contribute to innovative audit solutions and continuous third-party quality improvement.
  • Participate in critical cGMP compliance programs and inspection-readiness initiatives.
  • Work in an inclusive environment that values diverse perspectives and equal opportunity.

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