Ref No: AM17103
Co. Dublin, Ireland
Quality Services and Improvement Manager - Dublin (pharma).
In this role you will act as a key member of the Quality team.
In particular, as Quality Services and Improvement Manager you will be responsible for defining the strategic direction of the Quality Department, particularly focussing on Continuous Improvement (Agile) and Quality Culture activities.
• Defining and monitoring strategic objectives for the Cell Therapy Quality function in line with site and Global Quality objectives.
• Leading change and continuous improvement for the Cell Therapy Quality function.
• Actively participating in the site Agile programme as the being the Cell Therapy Quality representative.
• Defining and leading innovation projects within Cell Therapy Quality and participating in site innovation projects.
• Leading the Lab Excellence programme and participating in Global Lab Excellence activities.
• Leading the site Quality Culture programme and participating in Global Quality Culture activities.
• Defining and ongoing monitoring of the Cell Therapy Quality budget (Operational and Capex).
• Resource planning and monitoring of resource requirements within Cell Therapy Quality.
• Implementing and continually monitoring effective Key Performance Indicators within the Cell Therapy Quality Department.
• Effectively promoting and communicating Quality Improvement activities to the Cell Therapy manufacturing site and the global organisation.
• Acting as a designee to the Head of Quality as required.
• Supervisory duties for Quality personnel may be part of the role.
• Participate fully in any cross-functional training initiatives.
• Drive and promote the corporate values of the company within the workplace.
• Actively foster, in co-operation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
• Ensure timely completion of all SOP reading, training and assessment.
Interested applicants should have:
• Primary Degree in a scientific discipline
• Yellow Belt and Green Belt training is desirable
• Black belt training is an advantage
• Minimum of 7 years’ experience in the pharmaceutical industry
• Minimum 3 years’ experience in a Continuous Improvement / Agile role
• QC laboratory experience is strongly desired
• Cell Therapy and aseptic processing experience would be advantageous
• Strong leadership skills
• Excellent knowledge of cGMP
• High level of initiative
• Excellent verbal and written communication skills
• Strong project management and organisational skills
• Ability to adapt to changing priorities
• Ability to creatively come up with innovation solutions
• Excellent mentoring skills and the ability to bring a team together