Senior Quality Assurance Manager
Norgine, United Kingdom
Job Description
Norgine are looking to recruit a Senior Quality Assurance Manager to be based from the Hengoed site. As a Senior Quality Assurance Manager, you will act as the site lead for Regulatory and Customer (Quality) inspections, being the point of contact, leading inspections and ensuring that the site remains at a state of inspection readiness.
Responsibilities include but are not limited:
- Deployment of the Quality Strategy by development, implementation and management of key quality system elements that support Manufacturing amp; Supply activity.
- Implement and maintain quality systems consistent with the Quality Strategy to yield continuous improvement for processes and procedures
- Implementation of process improvement with effective use of resources
- Monitor regulatory and industry expectation and best practice to keep Norgine quality and manufacturing processes in a fit for purpose condition
- Manage implementation and provide oversight of quality systems providing guidance and expertise to departmental heads
- Identify training needs, develop and deliver training in relevant aspects of quality systems
- Develop, write, implement and train out Policy and Global SOP documentation.
- Monitor compliance with guiding documentation, report and take action as appropriate
- Develop and implement the strategy to ensure that the site remains at a state of continual inspection readiness
- To actively participate in the leadership of site, participating as a member of the site management team
- Provide the quality input and assessment through the presentation of the quality metrics
- Define and continuously review KPI’s used to monitor quality system status, develop and deliver proposals for remediation and improvement
- Conduct cGMP compliance audits
Experience Required:
- Pharmacy or Scientific Degree or equivalent, a seasoned professional with a professional qualification as desirable.
- Qualified Person under the Directive EC/2001/83 (preferred)
- An extensive knowledge of current GMP, GDP,GCP, ISO13485 standards and ICH guidelines for the manufacture of pharmaceutical products and medical devices.
- Experience auditing and in regulatory inspections in GMP/GDP/GCP/ISO environments.
- Experience of working within Quality Management Systems and knowledge of how they can add value and ensure compliance within a pharmaceutical company.
- Demonstrated operations experience with a can do approach.
- Demonstrated ability to lead, motivate and manage staff in a global multi-facility, matrix environment.
- Excellent influencing skills and ability to establish effective working relationships with personnel at all levels within Norgine.
If you think you have what it takes, you must apply to be considered.
Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.