QA/RA Manager (Pharmaceutical, Hybrid)

Job summary

This role involves leading the quality and regulatory affairs for pharmaceutical applications, establishing a robust Quality Management System (QMS) and ensuring compliance with relevant standards and regulations.

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Pharmacy, or a related field
• Over 7 years of experience in QA/RA within the pharmaceutical, biotech, or regulated industries
• Strong knowledge of ISO 9001, ISO 13485, cGMP, and FDA regulations

Responsibilities

• Develop and enhance the Pharma Quality Management System (QMS)
• Ensure compliance with pharmaceutical regulations and standards
• Serve as the primary QA/RA contact for regulatory authorities and customers
• Lead internal, supplier, and customer audits, addressing findings
• Manage processes for deviations, CAPA, change control, and risk management
• Support product development to ensure early compliance integration
• Review and approve validation strategies and technical documentation
• Monitor regulatory developments and implement internal requirements
• Foster a strong quality culture through training and improvement initiatives
• Define and track quality KPIs for performance optimization

Skills

• Strong communication and organizational skills
• Ability to influence and align stakeholders without formal authority
• Proficient in problem-solving with a structured and analytical approach
• Experience in cross-functional collaboration and project management

Education

• Bachelor’s or master’s degree in Life Sciences, Pharmacy, or a related field

Tools

• Familiarity with quality management systems and regulatory compliance tools
• Experience with LEAN principles for quality and efficiency improvement