JO-- Regulatory Compliance Associate Director Location: Fully on-site, Mayo (Biologics Contract Manufacturing) Overview Critical strategic hire responsible for leading and shaping the Quality function at a biologics manufacturing facility.
The role oversees the site Quality Assurance program, ensuring full GMP and regulatory compliance.
Responsibilities Lead, develop, and manage the on-site Quality Assurance program.
Ensure compliance with regulatory requirements and alignment with corporate policies.
Develop, maintain, and manage all QA documentation (SOPs, forms, procedures).
Oversee QA operational teams, ensuring timely and accurate audits, inspections, investigations, and reports.
Provide regulatory training, mentorship, and leadership to QA and operations staff.
Monitor effectiveness of QA systems and resolve compliance, scheduling, or interpretation issues.
Act as a key liaison with operations and regulatory bodies; manage client and agency interactions.
Ensure proper preparation, communication, and retention of all QA records.
Drive process optimisation and continuous improvement initiatives.
Requirements Bachelor's degree required; advanced degree in biological/pharmaceutical sciences preferred.
Extensive experience in GMP pharmaceutical/biotech environments.
Demonstrated leadership in managing QA programs, audits, inspections, and regulatory interactions.
Strong knowledge of national/international regulations, computerised system compliance, validation, and data integrity.
Skilled communicator with proven ability to lead teams and implement efficiency-improving practices.
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