Quality Management Systems Manager- Elstree- £55,000+
Director, Quality and Regulatory Compliance
As the global partner & leader of the quality management systems (QMS) team you will be responsible for developing & leading the Document Control, Change Management, Quality Management Systems.
Key Areas of Responsibility
You will be responsible for building and maintaining an effective and efficient quality management system.
- Has responsibility for Document Control, Change Management, CAPA and QMS teams by ensuring the deployment of the strategic direction, clear objectives and expectations. Ensure development of talent and a sustained high level of engagement.
- Fosters a positive employee relations environment by promoting open communication, engagement and development of team members. Promotes a culture of inclusiveness, trust, flexibility and teamwork.
- Develops and has responsibility to ensure strategic and global alignment of the QMS strategy with the Divisional and Corporate directions. Responsible for development of best in class QS practices and benchmark against industry leads and regulatory requirements.
- Responsible for oversight of all activities related to the maintenance the Quality Management System (QMS). Ensures QMS reflects actual activities and business needs, and ensures quality systems are developed, implemented and continuously reviewed to ensure compliance with all applicable regulatory requirements.
- Is responsible for assessment and approval of change control of quality system (BPO/QA approval) per regulatory and internal system requirements. Has strategic input in global process, system selection, vendor interaction and user requirement generation for QM Systems.
- Responsibility & oversight of the change control processes and review forums, ensuring effective management and approval of product/process changes for the sites.
- Understands and has knowledge of system integrations and contributes to development & generation of system requirements on a high level.
- Oversee the updating of monthly Quality Assurance KPIs on all key quality system related performance indicators. Report out and participate in quality review and planning processes.
- Supports sites' continued accreditation to all regulatory bodies, supports sites in all internal and external audit programmes. Ensures good relationships and collaboration with notified bodies to manage certification status & changes.
Qualifications Knowledge Skills
- Candidate must have successfully completed a BS of Engineering, Science or equivalent related qualification and have at minimum of 6 years relevant experience in a Regulated Industry.
- Minimum of 1-3 years' experience and a proven track record of successfully creating and managing highly talented, engaged and performing teams preferred with Multi Site responsibility
- Demonstrated ability to lead cross-functional teams
- Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously.
- Experience in quality management systems is essential
- Demonstrated process improvement and management skills.