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Job summary
A biopharmaceutical company in Lund is seeking a Senior QA Manager for Validation and Quality. This role requires a deep expertise in validation processes, alongside extensive knowledge in quality systems and compliance. The ideal candidate will have over 10 years of experience in the biopharmaceutical industry, managing validation activities and external partners. Join a growing team focused on life-changing outcomes for patients. This position fits those who thrive in innovative, collaborative environments.
Qualifications
10+ years of relevant biopharmaceutical industry experience, including significant QA roles.
Proven track record of leading validation activities for drug substance and product development.
Strong experience managing CDMOs/CMOs and authority inspections.
Responsibilities
Provide strategic direction for Quality Management activities.
Oversee implementation of quality and validation processes.
Manage relationships with external manufacturing partners.
Skills
Validation expertise
Quality systems knowledge
Supplier qualification
Risk-based compliance
Strong communication skills
Problem-solving abilities
Education
Ph.D. or M.Sc. in relevant field
Job description
A biopharmaceutical company in Lund is seeking a Senior QA Manager for Validation and Quality. This role requires a deep expertise in validation processes, alongside extensive knowledge in quality systems and compliance. The ideal candidate will have over 10 years of experience in the biopharmaceutical industry, managing validation activities and external partners. Join a growing team focused on life-changing outcomes for patients. This position fits those who thrive in innovative, collaborative environments.