Description
Global pharmaceutical company seeking Global Quality Compliance Manager to join their global quality team.The Role:
- In this position you will assist in providing objective, independent assurance that all global sites are operating in compliance with best practices and regulatory compliance requirements.
- A primary role of this position is the evaluation and implementation of standardized compliance and quality processes within the companies sites in route to sustainable compliance and all-time inspection readiness.
- You will perform independent evaluations of quality systems and practices at the companies sites located around the globe taking into considerations national and international regulations as applicable (FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, JP).
- Identify potential problems and coordinate resolution to issues prior to their having an adverse effect on the established business.
- Provide guidance on quality/compliance improvement as needed to assure sites are always prepared for Regulatory Agency inspections.
Requirements:
- A minimum of a Bachelor's degree (or equivalent) and a minimum of six years of relevant pharmaceutical compliance/quality experience are required. However, a combination of experience and/or education will be taken into consideration.
- Requires domestic and international travel (approximately 50% of the time).
- Certified Quality Auditor certification desired but not required.
- Ability to read and interpret comprehensive and intricate GMP and research documents; write evaluation/audit reports and technical correspondence.
If you would like to hear more about the role and company please contact me Anna Mooney or apply below with an up to date CV.