Join OmniaBio as a Quality Compliance Associate, where you will drive inspection readiness for audits in Hamilton, Ontario. Contribute to our mission by ensuring strict GMP compliance.
In this role, you will take charge of preparing for audits and inspections, collaborating closely with Quality Compliance and external regulators. You will actively manage all auditing processes, from planning and hosting to ensuring all commitments are addressed in a timely manner. A solid understanding of GMP regulations within the cell and gene therapy space is essential for success.
Key Responsibilities:
• Ensure high GMP compliance expertise in audits • Plan and set agendas for client and regulatory audits • Collaborate with business leaders for audit readiness • Address audit responses and manage commitments • Maintain thorough awareness of evolving GMP regulations
Requirements: • Bachelor’s degree in science or engineering • 5-10 years of industry experience in compliance • Experience in preparing for and responding to audits • Excellent understanding of Health Canada/FDA GMP regulations • Proven skills in cross-functional collaboration
Your contributions will fortify the standards of excellence at OmniaBio as we transform biomanufacturing.