Associate Director Engineering Compliance

MSD

Cork

Job Description. Our Brinny Site seeks to hire an Associate Director Engineering Compliance. The Associate Director Engineering Compliance is a member of the site Engineering Leadership team. Your core responsibility through the team is to monitor compliance metrics (EHS and Quality) for Engineering and highlight any trends or repetitive issues. You will play a key part in identifying negative trends and through teamwork and collaboration, working through problem solving identifying root causes and aligning on the corrective actions. This role also carries the responsibility for ensuring permanent inspection readiness for third part and internal compliance audits. In addition to monitoring and sponsoring the department compliance activities you will have accountability for the Engineering Continuous Improvement program. This will involve identifying areas for improvement, defining the business benefit and working through the operational engineering teams, delivering the agreed portfolio of projects. What you will do: Bring energy, knowledge, innovation and influence to carry out the following: Interpret internal and external regulatory (Quality and EHS) and compliance developments and communicates action to Department and site as appropriate. Ensure that departmental procedures are aligned with corporate standards and policies. This scope will cover EHS, GMP and Engineering standards. Gemba areas frequently, ensuring that areas are audit ready at all times. Through collaborative and open dialogue coach area owners in the compliance requirements. Assist them in formulating corrective plans where required and putting a process in place confirming that actions are addressed. Engineering Point of Contact for Inspections both internal and external agencies. Critical to the role is promoting the use of ‘Leader Standard Work’. Through the Eng. leadership team ensure that area owners are performing the duties set out in Leader Standard work and highlight any deficiencies. Works closely with team members on investigations to ensure that through thorough and robust investigation, true root causes are identified and robust CAPAs are generated and executed. Embed a culture of compliance and safety excellence within the Engineering team, and to work with compliance peers across the business to ensure best practice compliance is implemented. Accountable for development and deployment of visual metrics within the Department. Conduct field audits to verify that procedures, processes are completed to site requirements. Develop innovative lean compliance systems that anticipate future department needs aligned with industry best practice. Accountable for PIR (Permanent Inspection Readiness) within the department, including development and maintenance of a proactive compliance risk register for the Department to ensure consistent PIR. Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, Engineering Standards and EHS standards. Responsible for proactive monitoring of CAPAs to ensure holistic trends are proactively resolved. Responsible for overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA. Departmental Tier 4 owner for Compliance. Participate and comply with the our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Responsible for driving a culture of Continuous Improvement by deploying our company's Six Sigma tools. Model the our company's Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation. Owner for the departmental compliance calendar ensuring that all compliance activities for the department are tracked, highlighted and action plans are in place. Direct Management responsibility for Compliance Team. What skills you will need: In order to excel in this role, you will more than likely have: >15 years’ industry experience including time spend in a regulated environment. >5 years’ experience in operational leadership. Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical. Degree in (Science/Engineering. Demonstrated self-motivation/direction skills with a continuous improvement focus. Good understanding and demonstrated and for EHS and Quality guidelines and requirements. Good understanding and proven record working in a regulated pharmaceutical environment. Excellent facilitation skills to coach teams through problem solving events. Operational Engineering Experience working in a regulated environment. Strong desire and proven record to build capability within teams. Strong Facilitation skills for steering complex problem-solving events. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.  We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. .

1191 days ago