Senior Associate Quality Compliance

Job Summary

Supporting oversight of external Contract Manufacturing Organizations (CMOs), the remote Senior Associate Quality Compliance will manage product quality, ensure regulatory compliance, and align operations between external partners and internal teams on a contract basis.

Key responsibilities

• Manage product quality and compliance oversight for external CMOs and suppliers, ensuring adherence to global regulatory standards
• Act as the regulatory expert, performing impact assessments for Post-Approval Changes and coordinating regulatory strategies with global teams
• Lead and support audits and inspections, driving quality investigations and risk assessments while contributing to Quality Review Teams

Required qualifications

• Minimum of 5 years of experience in a GXP setting and/or Regulatory Affairs role with a relevant Master's degree
• Expertise in managing external suppliers and contractors, as well as Change Management and Regulatory processes
• Experience with Quality Management Systems (QMS) and electronic Quality Management Systems (eQMS) modules
• Knowledge of US, European, and global cGMPs and compliance issues
• Demonstrated technical know-how in industry quality assurance practices