Alvotech hf
Alvotech hf
Alvotech hf

Quality Control Strategic Lead

Quality Control has a exciting opportunity within the team to further support our commitment to improving lives by expanding access to more affordable biologic medicine. The role is cross-functional and plays a part in various places in the value stream such as regulatory and filing support, analytical technical transfer, reference material, compliance to guidelines and participations in inspections

Helstu verkefni og ábyrgð
  • Reporting to Head of Quality Control
  • Manage strategy of all method transfers for QC, including protocol/report/gap analysis generation, review and approval between the receiving and transferring unit.
  • Strategic partner on behalf of QC in cross-functional activities with project leads and program managers.
  • Responsible for documentation and strategy of qualification of in-house reference material.
  • Participate in preparations for regulatory submissions, inspections, and responses to health authorities.
  • Other topics that require strategic leadership or input.
Menntunar- og hæfniskröfur
  • Minimum B.S in a technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
  • 10+ years of experience in pharmaceutical industry.
  • Experience in quality management system, method transfers, regulatory submissions, reference material qualification and working cross functionally.
  • Good conceptual, problem-solving, and organizational skills – must be detail-oriented, well-organized, and able to work independently and in teams.
  • Open to flexible working hours.
  • Excellent written and verbal communication skills.
Auglýsing birt15. nóvember 2024
UmsóknarfresturEnginn
Tungumálahæfni
EnskaEnska
Nauðsyn
Mjög góð
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar