Job Title: Regulatory Compliance Associate Director
This is a Critical Strategic Hire responsible for leading and shaping the Quality function at a biologics manufacturing facility.
Key Responsibilities:
* Lead, develop and manage the on-site Quality Assurance program to ensure full GMP and regulatory compliance.
* Ensure compliance with regulatory requirements and alignment with corporate policies.
* Develop, maintain and manage all QA documentation (SOPs, forms, procedures).
* Oversee QA operational teams to ensure 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.
* Skillful communicator with proven ability to lead teams and implement efficiency-improving practices.