Senior Specialist Global Quality Excellence (stability Programs)

Merck Merck · Pharma · North Brabant, Netherlands

Senior Specialist Global Quality Excellence (Stability Programs) at Merck's Animal Health organization. Focuses on optimizing stability programs across the global manufacturing network by reducing ongoing stability testing in a science-based and risk-based way, aligned with GMP and regulatory expectations. Supports Quality 31 productivity initiatives.

What you'd actually do

  1. Act as global point of contact for sites on Stability Program Reduction opportunities within Quality 31.
  2. Support the implementation of lean ongoing stability program strategies aligned with global Health Authority requirements.
  3. Collaborate with site Quality, QC, and Laboratory teams to translate global strategy into practical site-level opportunities.
  4. Support the development of scientific and regulatory justification packages for stability reduction initiatives.
  5. Facilitate risk assessments, including product risk profiles, bracketing approaches, alternative approaches, stability protocol updates, and change controls.

Skills

Required

  • Bachelor’s degree in Life Sciences, Chemistry, or related scientific discipline
  • Strong knowledge of GMP and pharmaceutical/animal health quality systems
  • Relevant experience working in Quality, QC, or Analytical environment
  • Demonstrated ability to work cross-functionally and across multiple sites, including influencing without direct authority
  • Strong analytical, (technical) documentation, and communication skills
  • Excellent command of the English language, oral and written
  • cGMP Regulations
  • Change Management
  • Deviation Management
  • Good Automated Manufacturing Practice (GAMP)
  • Manufacturing Quality Control
  • Pharmaceutical Quality Assurance
  • Quality Auditing
  • Quality Management Standar

What the JD emphasized

  • fully aligned with GMP
  • global regulatory expectations
  • science-based and risk-based way