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GMP Compliance Assurance Manager
2 weeks ago
Job Description
We are seeking an experienced GMP Compliance Assurance Manager to join our team, responsible for ensuring adherence to cGMP Quality Management System and EH&S requirements.
Key Responsibilities:
- Oversee the development and implementation of effective quality systems to ensure high compliance levels.
- Cultivate a high-performing team through coaching, mentoring, and providing opportunities for growth and development.
- Work collaboratively with cross-functional teams to identify and address operational gaps, ensuring seamless execution of processes.
- Develop and maintain quality documents and records, ensuring alignment with global and local regulatory requirements.
Requirements
- Tertiary education in a science or engineering-based field (e.g., biopharmaceutical manufacture, biotechnology, process technology).
- 5-7 years of experience in leadership roles within a Biopharmaceutical GMP manufacturing environment.
- Proven knowledge of Biologics processing and compliance management within GMP/GLP regulations.
- Excellent interpersonal, scheduling, and planning skills, with the ability to work unsupervised.
Benefits
- A comprehensive benefits package, including health and wellbeing programs, flexible arrangements, extra leave, charitable giving and volunteering opportunities, learning and development initiatives.