Qualifications

• Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
• Experience in a GxP biotechnology or pharmaceutical environment required; biologics/cell therapy experience preferred.
• Knowledge in quality assurance within highly regulated manufacturing environments.
• Experience with Contract Manufacturing Organizations (CMOs).
• Familiarity with regulatory inspections preferred.
• Extensive knowledge of US cGMP, GDP compliance regulations, and EU GMP requirements.
• Strong problem-solving skills with attention to detail; ability to manage multiple priorities.

Responsibilities

• Support quality management reviews and product assessments.
• Lead the review and release process for clinical trial materials.
• Create, review, and approve GMP-related documents such as SOPs and batch records.
• Coordinate investigations and implement corrective actions.
• Manage change control processes with stakeholders both internally and externally.
• Support internal and external audits to ensure compliance.
• Collaborate with cross-functional teams to address quality-related issues.
• Assist with validation activities at contract sites.
• Promote a culture of quality and operational excellence throughout the organization.

Benefits

• Support for professional development and continuous improvement initiatives.
• Opportunity to work in a collaborative, fast-paced environment.
• Exposure to advanced biotechnology practices and regulatory standards.
• Engagement with a strong commitment to quality and integrity.