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Quality Manager Corporate Systems & Projects - HELM Pharmaceuticals (m/f/d)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Germany
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
Quality Manager Corporate Systems & Projects (Pharmaceutical Quality): Supporting finished dosage form programs and optimizing HELM’s global Pharmaceutical Quality System across EU and US markets with an accent on regulatory compliance, quality procedures, audits, and clinical quality assurance. Focus on advising cross-functional teams on EMA, FDA, and EU-GMP requirements, maintaining PQS documentation, qualifying suppliers, and troubleshooting quality topics across pharmaceutical development and manufacturing.

Location: Hamburg, Germany

Company

hirify.global is a global family-owned pharmaceutical and chemicals business focused on future-oriented solutions across its international network.

What you will do

  • Support finished dosage form programs across quality-relevant activities from development through product launch.
  • Maintain and further develop global and local Pharmaceutical Quality Systems in line with corporate objectives and regulatory requirements.
  • Ensure regulatory compliance for wholesaler, importer, and medicinal product and API release activities.
  • Provide quality support for clinical development, including oversight of GCP Quality Assurance.
  • Review, implement, and optimize global quality procedures while contributing to the Quality Maturity Program.
  • Own quality topics including Quality Agreements, supplier qualification, PQS documentation, GMP audits, and technical troubleshooting.

Requirements

  • Master’s degree in Pharmacy, Chemistry, Biology, or an equivalent scientific discipline.
  • Several years of experience in pharmaceutical Quality Management, ideally in a generics environment.
  • Strong knowledge of EU and US pharmaceutical regulations and German drug law.
  • Experience with audits, clinical quality management, and pharmaceutical development and manufacturing processes.
  • Proficiency with MS Office and quality-related IT systems such as eQMS, LIMS, or project management tools.
  • Excellent English communication skills and the ability to work effectively in international, cross-functional teams.

Culture & Benefits

  • International work opportunities within a global network.
  • Seminars and further training opportunities.
  • Benefits designed to support work-life balance.
  • Collaborative environment with cross-functional and international teams.

Hiring process

  • Submit an application with the necessary documents through the application portal.

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