Senior Manager, GCP/GVP Quality Assurance
Qabird
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Benefits offered by this job
Job summary
Pharming is seeking a Senior Manager CQA to provide strategic and operational leadership for clinical quality and pharmacovigilance. You will oversee GCP and GVP activities, work with cross-functional teams, and ensure compliance with global regulations.
The role leads the CQA team and drives risk-based quality management across the product lifecycle. You will collaborate with Clinical Development, Regulatory Affairs, and external providers, ensuring data integrity, participant safety and
Qualifications
- Master’s degree in life sciences, pharmacy, medicine or related field.
- At least 8 years in pharma/biotech with 6+ years in QA and GCP/GVP responsibility.
- Strong knowledge of global GCP/GVP requirements and related regulations.
Responsibilities
- Provide independent GCP/GVP oversight for clinical development and pharmacovigilance.
- Oversee lifecycle management of quality-system documents and procedures.
- Lead quality risk assessments and escalate material risks.
- Maintain inspection readiness and coordinate regulatory inspections.
Skills
Education
Tools
Job description
Pharming is seeking a Senior Manager CQA to provide strategic and operational leadership for clinical quality and pharmacovigilance. You will oversee GCP and GVP activities, work with cross-functional teams, and ensure compliance with global regulations.
The role leads the CQA team and drives risk-based quality management across the product lifecycle. You will collaborate with Clinical Development, Regulatory Affairs, and external providers, ensuring data integrity, participant safety and
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