A leading medical device manufacturer requires an experienced Quality Manager to join its team. As Quality Manager you will lead and oversee all QA functions and staff at the Kent facility. To be considered you must have proven experience working with steriles and significant experience in leading and managing cross-functional teams.
Working pattern: Monday – Friday 8.30am – 16.30pm
To manage and oversee all QA functions and staff within the Ashford facility including Management responsibility Design controls Production and process control Microbiology and CAPA. Application and execution of appropriate governance and reporting models to ensure efficient running of the department in order to match financial production and business requirements.
Drive continual improvement within the function and peer functions ensuring an efficient Quality System is established to support the strategic needs of the business and ensure ongoing compliance to all appropriate regulatory and company requirements.
Ensure ongoing people engagement performance and potential through effective succession planning identification and development of appropriate personal and competencies to constantly drive towards best in class execution and state of the art capabilities of QA functions.
- Management representative for the facility.
- Ongoing promotion and development of all GMP/cGMP activities across the facility and facility management including critical process monitoring and deviation management.
- Establishment and overall responsibility for Management Review CAPA Internal Audit Material release Non-conforming product and material control and disposition Microbiological and chemistry deviation management customer complaints Calibration and validation.
- Establish core KPIs to drive ongoing performance and timeliness of execution such as CAPA Internal audit Calibration training and deviation management.
- Report ongoing performance to the business ensuring priority deficiencies are reported in a timely fashion.
- Preparation and management of departmental budgets
- To ensure that all appropriate engineering and improvement projects have the necessary QA support and remain compliant with all current aspects of GMP/cGMP and change management.
- Control of investigation into customer complaints ensuring reports are compiled and issued in a timely manner
- To review outgoing quality performance ensuring deficiencies and solutions are identified and managed in a timely fashion to ensure ongoing risk mitigation.
- To review validation plans protocols and reports as necessary
- To review manufacturing changes and deviations
- Any other related duties connected with the Company’s business as may be required.
- Proven experience in management positions; Leadership motivation and management including succession planning
- Communication and upward management
- Prioritisation and execution
- Resource management and balancing
- Functional line of sight and alignment
- Functional skills and experience
- Broad Problem Solving methodology and tool use
- Process validation
- Sterile and Aseptic processing
- CAPA execution and management
- Risk management and design transfer including PFMEA
- Broad regulatory experience including FDA inspection
- Ability to read and author technical documentation
- Sterile and aseptic processing preferably within water environments.
- Medical device min level 2 or Pharma
Salary £60k - £65k
Job Ref: 6184