The Quality & Regulatory Director role is a senior leadership position responsible for ensuring compliance with international standards and local regulations across the distribution of medicines and diagnostic products. This role plays a critical part in maintaining a robust quality system and safeguarding regulatory integrity while supporting organisational objectives.
Responsibilities
Maintain and oversee the quality system in alignment with GxP principles and corporate policies
Monitor and manage customer quality complaints, ensuring appropriate communication of outcomes to customers
Oversee supplier performance and compliance, including audits of distributors, warehouses and service providers
Lead the implementation and maintenance of SOPs, work instructions and internal training programmes
Coordinate product recalls, field corrective actions, and the management of deviations and corrective actions
Host and manage internal audits and external inspections from regulatory authorities
Act as the primary regulatory contact with local authorities and ensure all licences for distribution activities are obtained and maintained
Review and approve promotional materials to ensure compliance with local regulatory requirements
Requirements
Degree in Pharmacy or an equivalent qualification
At least 5 years of experience in quality and regulatory roles within a pharmaceutical company
Proven experience in implementing and maintaining quality systems
Strong knowledge of applicable regulations and compliance practices
Advanced MS Office skills; SAP experience preferred
Highly organised with the ability to manage multiple tasks simultaneously
Strong communication skills and ability to work collaboratively across teams
Benefits
Health Insurance
Employees' Pension
Employment Insurance
Industrial Injury Insurance
About the company
A company in the biopharmaceutical and healthcare industry, operating globally with a strong focus on improving patient outcomes through innovative therapies and diagnostic solutions. The organisation supports medical advances and healthcare delivery through a broad portfolio of products and services, underpinned by a commitment to quality and sustainability.