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.