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3 дня назад

Manager AVA/Mycoplasma Quality Control (Pharmaceutical Quality Control)

68 600 - 119 600€
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Netherlands
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Manager AVA/Mycoplasma Quality Control (Pharmaceutical Quality Control): Leading AVA and Mycoplasma release and stability testing for biotherapeutic products in a GMP-regulated pharmaceutical laboratory with an accent on viral and microbiological methods, data integrity, and team performance. Focus on managing specialized QC teams, resolving laboratory investigations and CAPAs, supporting audits, and driving automated testing and new product introduction.

Location: Leiden, South Holland, Netherlands

Salary: €68,600–€119,600 base pay annually

Company

Johnson & Johnson MedTech, through Janssen Biologics, develops and manufactures biotherapeutic products for cancer, infectious, cardiovascular, metabolic, and immune-mediated inflammatory diseases.

What you will do

  • Lead the AVA/Mycoplasma Quality Control team responsible for timely release and stability sample testing.
  • Ensure laboratory activities comply with safety policies, quality systems, pharmaceutical GMP requirements, regulatory standards, and data-integrity expectations.
  • Set departmental objectives and performance indicators while managing staffing, budgets, resources, and operational priorities.
  • Lead supervisors and specialists, provide strategic and operational guidance, and develop team capabilities through servant leadership.
  • Coordinate investigations of out-of-specification and invalid assays, CAPAs, change controls, audits, and health-authority inspections.
  • Collaborate with Quality Assurance, Analytical Development, Manufacturing, Technical Operations, Engineering, Maintenance, and global stakeholders on new product introductions and automated testing solutions.

Requirements

  • Master’s, PhD, or equivalent degree in virology, microbiology, life sciences, biotechnology, or a related field.
  • 5–10 years of experience in viral and microbiological method development and validation.
  • Experience leading a specialized group of more than 20 people, including 5–10 direct reports.
  • Pharmaceutical Quality Control experience with marketed products and profound knowledge of pharmaceutical regulations and cGMP principles, including FDA and EU requirements.
  • Strong organizational planning, problem-solving, leadership, team development, presentation, analytical thinking, and quality-awareness skills.
  • Experience with Process Excellence principles and digitalization or digitization initiatives.

Nice to have

  • Experience with Next Generation Sequencing and rapid microbiology testing methods.
  • Knowledge of benchmarking, operational excellence, performance measurement, product testing, QMS, quality validation, SOPs, and tactical planning.

Culture & Benefits

  • Inclusive work environment guided by the company’s Credo and focused on diversity, dignity, and employee development.
  • Annual bonus or sales commission opportunities depending on pay grade, location, and performance.
  • Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
  • Well-being reimbursement and programs supporting financial, physical, and mental health.
  • Insurance plans, service anniversary awards, and recognition programs subject to applicable plan terms.

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