QA Manager

Job summary

The QA Manager will oversee complaint management systems and processes for both clinical and marketed products, ensuring compliance and effective collaboration with internal and external stakeholders.

Qualifications

• Master's degree in life science, pharmacy, or a related field
• Experience in the life science industry
• Familiarity with complaint processing for drugs, medical devices, and drug-device combination products
• Strong understanding of GMP requirements and Quality Systems in pharmaceutical development and manufacturing
• Experience with electronic Quality Management Systems (eQMS), preferably Veeva Vault
• Proven ability to deliver compliant solutions in a structured and approachable manner
• Excellent written and verbal communication skills, with the ability to engage with external suppliers and partners; willingness to travel as needed

Responsibilities

• Develop and enhance internal complaint management competencies
• Manage complaint processes, including stakeholder coordination and support
• Collaborate with Manufacturing QA, CMOs, and Partners on complaint-related issues
• Continuously improve complaint and recall processes, including documentation and training
• Oversee recall activities and mock recalls
• Contribute to the optimization of Veeva Quality Vault and related processes
• Utilize quality data for reporting and continuous improvement initiatives

Skills

• Strong collaboration and communication skills
• Ability to build trusted relationships with stakeholders
• Pragmatic approach with a focus on compliance

Education

• Master's degree in life science, pharmacy, or similar

Tools

• Veeva Quality Vault, electronic Quality Management Systems (eQMS)