Quality Systems Manager
You have the chance to join an exciting, growing company that are looking to invest in new & innovative products as well as shaping new departments. This Quality Systems Manager position is brand new to this department & as part of a new department you will be involved in shaping the future of this team.
This company are ambitious & dedicated to increasing their market share. As they are passionate about being market leaders & being at the forefront of new product development, they are continuing to invest in the quality of their product range. As the Quality Systems Manager you will be an integral part of their ongoing journey, influencing the scope of their already promising future.
As the Quality Systems Manager, you will be working alongside key stakeholders (including external counterparts) to ensure that the Quality Systems are designed, developed, established & monitored. You will be responsible for ensuring the business provide robust & effective procedures in compliance with the appropriate GxPs, national & international legislation.
Key responsibilities include:
- Demonstrate effective leadership principles in order to achieve both functional & business objectives, providing direct oversight & guidance to the business in the area of Quality Management Systems.
- Ensure effective quality systems are established and maintained at both internal & external counterparts to enable the business to operate in an effective manner and in compliance with applicable legislation.
- Provide advice to the Regulatory Affairs group on topics concerning Quality and Licensing.
- Ensure systems are established to maintain visibility and awareness of changes in legislation, guidelines and pharmacopoeias, recommending areas for action and implementing change as required.
- Support the wider management of inspections by regulatory bodies as needed across CMO networks
- Conduct inspection readiness audits developing remediation plans as needed in conjunction with the IAC management teams.
- Supports and conducts Due Diligence, site visits and quality audits on request.
- Work closely with other functions (e.g. Quality, Planning, Supply Chain Coordinators, NPI, External Warehouses, Internal Customers, etc.) to ensure product can be compliantly distributed to market in support of product demand.
- Support and develop other members of the Quality teams within the region, where required to ensure they have the appropriate skills knowledge and expertise for the current and future success of the business.
- Support the process of continuous improvement with the aim to reduce cost, improve quality and increase efficiency.
ALL THOUGH BASED IN CAMBRIDGESHIRE THIS ROLE WILL INVOLVE INTERNATIONAL TRAVEL
Quality professional with experience managing systems within a pharmaceuticals company. The successful applicant will also have:
- A high level of understanding & interpretation of Global GMDP guidelines (EU, FDA, PIC/S, WHO) & legislation (EU, FDA)
- An understanding of GMDP audits with experience in the assessment of the products & manufacturers (ideally a lead Auditor)
- An understanding of manufacturing processes & the quality systems within them
- Proactive, independent, organised and self-confident
- Strong interpersonal and communication skills
- Customer focused and cross-functional thinking and behaviour
- Clear communication engaging others to enable understanding
- Works collaboratively maintaining good working relationships with cross functional teams and partners actively participating contributing to team success
- Excellent English language skills both spoken and written. Additional languages beneficial
- Is able to travel up to 50% of time (World-wide travel)
Circa £70,000 - £80,000 + Benefits