Quality Assurance Manager
Based in New Zealand
Competitive Package + Relocation + Benefits
Work Visa Available
Do you have leadership experience gained in a pharmaceutical Quality environment?
Would you like to explore a new a fantastic opportunity to live and work in New Zealand?
My client is a multi-national pharmaceutical company with a site of excellence in New Zealand. Their work is within the research, development, and manufacture of novel drug products & APIs, and due to continued growth are looking to hire a Quality Assurance Manager.
The Quality Assurance Manager will report to the Head of Quality and will be responsible for effectively leading the Quality Assurance team to enable the Company’s quality management systems (QMS). The Quality Assurance Manager aims to ensure that the QMS supports effective and compliant manufacturing operations, distribution and support processes for products that meet Regulatory, GMP requirements and customer requirements. The Quality Assurance Manager is responsible for leading a team of Quality Engineers which provide Quality Assurance support to Manufacturing, Engineering, Maintenance, Supply Chain and Quality Control Laboratories.
This QA Manager role is concerned with monitoring and advising on the performance of the quality management system, releasing materials and product for distribution, producing data and reporting on performance, measuring against set standards. The QA Manager will enable a culture of continual improvement and deploy a risk-based approach as a key to a successful QMS, liaising with other managers and staff throughout the organisation to ensure that the quality management system is functioning properly. Where appropriate, the QA Manager will advise on changes and how to implement them, providing training, tools, and techniques to enable others to achieve quality standards.
This position provides QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigations, corrective/preventive action plans and change control documents. This position also participates as an SME in external and internal audits of operational areas, provides support, direction, and representation for quality management as a decision maker and may serve as back up for the Head of Quality when required.
To be considered for the Quality Assurance Manager position, you’ll need the following skills and experience;
- Considerable experience leading a quality, technical or validation team in a pharmaceutical organisation.
- Development of product specifications and or processes as meet market quality requirements
- Development & execution of QA systems and procedures with an emphasis on validation in a GMP environment
- Regulatory audit exposure (e.g. MHRA, FDA, TGA or equivalent) with a good eye for detail.
- Excellent communication skills, able to communicate effectively at all levels of an organisation
- A customer focus, with a desire to ensure the best service for patients and customers
- Excellent team working, organisation and decision making skills
Key Words "GMP, QMS, QA Manager, Quality Assurance Manager, Pharmaceutical, API, Drug Product, Drug Substance, Validation, Team Leader"
Please apply online or contact Neil Walton at CY partners for further details