QA/RA Pharma Manager

• Develop, implement and continuously improve the Pharma Quality Management System (QMS)
• Ensure compliance with applicable pharmaceutical regulations and standards (e.g. ISO, cGMP, FDA, EMA)
• Act as the primary QA/RA contact towards regulatory authorities, notified bodies and customers
• Lead and manage internal, supplier and customer audits, including follow-up on findings
• Establish and govern processes for deviations, CAPA, change control and risk management
• Support product development and lifecycle management to ensure compliance is built in from early stages
• Review and approve validation strategies, protocols and relevant technical documentation
• Monitor regulatory developments and translate them into actionable internal requirements
• Drive a strong quality culture through training, coaching and continuous improvement initiatives
• Define and track quality KPIs to ensure transparency, performance and ongoing optimization

• Bachelor’s or master’s degree within Life Sciences, Pharmacy or a related field
• +7 years of experience within QA/RA in the pharmaceutical, biotech or other regulated industries
• Strong knowledge of relevant standards and regulations, including ISO 9001, ISO 13485, cGMP and FDA 21 CFR Part 11
• Experience with risk management (e.g. ISO 14971) and validation processes
• Proven ability to establish, maintain and improve quality management systems in a global environment
• Experience in conducting internal and external audits and ensuring an organization is ready for audit
• Experience working cross-functionally and managing multiple projects simultaneously
• Strong communication, organizational and stakeholder management skills
• Fluency in English, both written and spoken, and preferably also in a Scandinavian language

Fluency in a Scandinavian language