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Senior QA Manager Validation & Quality

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Life Science Talent

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Location:
Sweden , Lund

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Category:
IT - Administration

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

This role combines deep expertise in validations (e.g process, cleaning, analytical method) from a quality perspective with strong capabilities in quality systems, supplier qualification, and risk-based compliance. The role will act as a subject matter authority for validation and QA processes, supporting cross-functional teams and driving quality excellence across internal operations and external suppliers.

Job Responsibility:

  • Provide strategic and operational direction for quality expectation including validation within drug substance and drug product process development, scale-up, technology transfer, and manufacturing activities
  • Oversee development and implementation of quality and validation processes to ensure compliant, robust and cost-effective manufacturing processes for development, clinical and commercial supply
  • Manage external manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives
  • Support authority inspection and internal Hansa/external audits of suppliers and vendors
  • QA review and approval of validation documentation
  • Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain
  • Establish and maintain strong relationships with internal and external stakeholders to ensure seamless execution of QA strategies and operational tasks
  • Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement

Requirements:

  • Advanced degree (Ph.D. or M.S.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline
  • 15+ years of relevant biopharmaceutical industry experience, including significant roles in QA process development, manufacturing and validation
  • Strong knowledge and experience of biotech and aseptic manufacturing incl testing
  • Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation
  • Strong experience managing external partners and CDMOs/CMOs
  • Strong experience of Authority inspections as presenter, coordinator (FDA, EMA and other markets)
  • Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages
  • Strong communication, and interpersonal skills with the ability to influence across functions and levels
  • Strong problem-solving skills and a hands-on, execution-oriented mindset
What we offer:
  • A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions
  • The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people
  • An opportunity to build a fully integrated biopharmaceutical company with global outreach
  • An open-minded and welcoming atmosphere
  • Friendly, motivated and skilled colleagues with whom you can both laugh and work

Additional Information:

Job Posted:
January 15, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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