Head Of Quality

Description:

Lead and oversee the Quality team, ensuring robust compliance with regulatory standards and internal quality systems. This role is responsible for managing all aspects of Quality Assurance (QA), including audits, CAPA oversight, and FDA readiness, while maintaining and improving QA systems across the organization.

Responsibilities:

• Direct and support all QA functions, including documentation, audits, investigations, and regulatory compliance.
• Maintain and enhance quality systems in alignment with GMP, GxP, and FDA regulations.
• Lead CAPA initiatives and ensure timely resolution of quality issues.
• Collaborate cross-functionally to support manufacturing operations and continuous improvement efforts.
• Provide strategic leadership and mentorship to the Quality team.

Required Skills:

• Quality Assurance
• Audit Management
• FDA Compliance
• CAPA Oversight
• GMP/GxP Knowledge
• CDMO Experience

Top Skills:

• Quality Assurance
• Audit
• FDA
• CAPA

Additional Qualifications:

• Proven leadership experience in Quality roles within biopharma or CDMO environments.
• Bachelor’s degree or higher in a Life Science discipline.
• Expertise in managing regulatory inspections and quality systems.