Quality & Regulatory Director (Healthcare)
Key Decision Maker in the organisation to develop system and the team
Competitive Salary plus Car, Performance bonus, and Benefits
GAMA Healthcare is a global company with over 150 staff with offices based in the United Kingdom, Australia and China. We are market leaders in various infection prevention and control solutions, our range of Clinell products combine innovative technology with ease of use, providing the professional healthcare industry with the most effective options available. Our mission is to reduce worldwide infections by offering the best innovative solutions together with market leading after sales support.
Founded in 2004 by two medical doctors, GAMA Healthcare has become a world leading developer and manufacturer of infection prevention technology. The Clinell brand is well known to the NHS, providing a range of product lines for surface care, hygiene monitoring, and patient skincare.
In April 2018 GAMA Healthcare received the Queens Award for Enterprise in International Trade and were also recognised by The Sunday Times for the HSBC International Track 200 Award. In less than 10 years, revenues now account for a turnover in excess of £30 million and double-digit growth is forecasted over the next 5 years.
GAMA Healthcare seeks a highly experienced, solution focussed, Quality Assurance Director who would have overall accountability in leading GAMA China's Quality Assurance function. In particular, the Director will ensure that appropriate levels of performance are achieved by GAMA's suppliers and that all applicable local and international regulatory requirements are complied with and that the product quality meets quality standards.
The successful candidate will be critical in building and developing a strong and credible team capable of partnering with business functions and external stakeholders involved in the manufacturing and sales of GAMA products.
- Develop and maintain GAMA China quality processes and a management system aligned to GAMA UK and meeting the requirements of recognised international standards (including ISO13485).
- Maintain product quality by implementing quality assurance policies and procedures. Co-ordinate between suppliers and internal GAMA teams to resolve product issues and improve product quality.
- Collaborate with internal GAMA teams to ensure that new product designs and changes are transferred to external manufacturers following appropriate quality assurance standards and methods.
- Accountable for the application of procedures, monitoring methods and audit protocols to ensure that raw materials and finished products meet GAMA's specifications.
- Ensure that internal audits are conducted to professional standards and that findings are recorded and followed up appropriately
- Ensure that GAMA China suppliers are managed and improved through the application of product specifications; supplier evaluations and audits; reporting and escalating KPIs. Manage non-conformities and follow up of corrective actions. Monitor and reduce waste and rejected materials while maintaining product quality
- Ensure prompt investigation and resolution of quality issues for products manufactured by GAMA China suppliers (including customer complaints and product failures)
- Ensure that GAMA China achieves local and regional product registrations and licences in line with relevant regulatory frameworks* to enable product sales within China (and other markets managed by GAMA China). This includes any necessary testing; submission of dossiers and ensuring suitability of product labelling.
- Provide leadership and manage the performance of all members of China QA team, ensuring the team are motivated, clear on their priorities and are working collaboratively with cross-functional teams to achieve collective goals.
- Manage staff development and training ensuring that the team are multiskilled and empowered in their support of various cross-functional teams and projects. Act as coach and mentor to ensure talent is developed in line with business requirements and personal capabilities, particularly in the area of Quality Management.
- Provide advice on quality and regulatory requirements to key stakeholders as appropriate.
- When required contribute towards GAMA's strategic goals and the achievement of GAMA's annual priorities, with particular focus on compliance and quality of products manufactured by GAMA's external manufacturing partners.
- Ensure team projects are appropriately prioritised and regulatory plans are monitored, communicating with key stakeholders to manage expectations effectively.
- Provide advice and pro-active updates to key stakeholders (China Management / UK Regulatory) on the compliance status of GAMA's external manufacturing partners and sales activities managed from China
- Proactively build / strengthen external stakeholder contacts (e.g. regulatory and certification agencies, industry organisations and business partners)
- Minimum of 10 years' experience in Quality Assurance in a relevant regulated environment (Medical Devices, Biocides, or Pharmaceuticals products).
- 3-5 years management of ISO9001 or ISO13485 Quality Management Systems to drive business performance and efficiency and drive supplier performance.
- At least 3-5 years leading, managing and developing professional teams.
- Experience of working effectively in an entrepreneurial, fast paced international organisation.
- Managing supplier performance within a quality management system
- Experience of operating in an international environment and managing a variety of market-specific regulatory frameworks. (Desirable)
Knowledge / experience with Risk Management and US Good Manufacturing Practice, Medical Devices, Biocides, Pharmaceuticals, Cosmetics, Detergents, Personal Protective Equipment, Electromagnetic Compatibility. (Desirable)
- Key Decision Maker in the organisation to develop system and the team
- Competitive Salary and Compensation is provided