JO-2512-560242
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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