Operations Director, Medical Devices/ Pharmaceutical
Type: Permanent
Location: Coventry (fully onsite with occasional flexibility when needed)
Salary: (to be discussed on screening calls)
Additional: Enhanced bonus, private medical (cash plan initiative available), income protection, enhanced pension options
Our Client, an established medical devices company (part of a global group) - is looking to recruit for an experience Operations Manager/ Operations Director to work at their modern site on Coventry. This is a strategic role, we do require that the successful Candidate is based onsite / this is not a hybrid position. There is occasional business travel, but not regular.
The Role:-
• Ensure compliance with all Health and Safety and Environmental requirements. To implement and maintain such systems to reach this aim.
• Remain well informed of relevant Health and Safety and Environmental policies and regulations and lead the Company's engagement with associated external auditors
• Oversee and agree production schedules and adherence to such schedules to fulfil customer orders on a timely basis and hence allow achievement of Clients On Time Delivery performance targets.
• Ensure that production performance is in line with agreed efficiency and cost targets.
• Ensure safe operation of the factory - accident monitoring/Zero LTI's, EMS compliance.
• Oversee design transfer activities to allow the efficient transfer of R&D projects in to stable production processes with acceptable production rates, yields and ongoing manufacturing costs.
• Ensure that all production processes provide efficiencies required to achieve agreed targets whilst maintaining compliance to all relevant medical device regulations.
• Oversee purchasing of raw materials, consumables and all Operations Capital Equipment to provide best value the Client.
• Ensure that the Client's logistics and material transfer functions contribute positively to achieving appropriate targets.
• Oversee maintenance of facilities and Production and Quality Control related equipment in line with Clients policies to allow optimal throughput and minimal delay-causing equipment downtime.
• Recommend process or technical investment and development plans along with strategic direction for the Client and specifically Operations in line with both short and long term business priorities. Oversee the installation of such approved equipment or changes.
• Ensure that all Quality Control activities are conducted in line with Client's policies and procedures
• Ensure the timely testing and reporting of results and where appropriate production of Certificates of Analysis to allow product release and hence achievement of Client On Time Delivery performance targets.
• Motivate and support teams and team leaders/supervisors/managers by frequent communication and briefings, dealing promptly with issues, arranging necessary training and development, setting and reviewing short term objectives, and monitoring performance.
• Support direct reports in achieving training and development of teams and individuals to enhance performance relative to the business objectives.
• Ensure Operations agreed budget costs are not exceeded.
• Responsible for activities as defined in ISO13485 section 5 (to be superseded by ISO13485:2016).
• Attend Client's Quality Management Review.
• Manage Health Safety and Environmental related activities.
• Lead focus on investigation and resolution of assigned Operations related CAPA's.
• Champion compliance to relevant medical device standards through ensuring that all Operations activities are performed in accordance with issued procedures and that any non-compliant activities are fully resolved or highlighted to the Managing Director and Director of QA/RA.
The Person:-
• Demonstrable/ significant management experience in an medical devices and/or possibly a pharmaceutical setting.
• Strong project and budget management experience (in above settings)
• Understanding of MDR (ISO 13485) ((will possibly consider GMP))
• Experienced in lean manufacturing and process improvement
• Good grasp on running data analytics & presenting key data (forecasts, analysis tools, budgets etc)
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