Our client, a pharmaceutical company in Cork are currently looking to recruit an Associate Director of Engineering Compliance for their site.
Purpose of Role:
The Associate Director of Engineering Compliance is responsible for maintaining all aspects of compliance within the site Engineering team, including GMP, EHS, Technical and Engineering compliance. The leadership style is one of collaboration, coaching and facilitating the team to a high performing organization. This will require a substantial amount of time with the various Engineering areas such as Utilities, Capital Projects, Facilities, Engineering Centre of Excellence. The Associate Director of Engineering Compliance moulds the culture to one that supports a High Performance Organisation.
- Personal accountability and responsibility, continuous self-development through colleague collaboration in an open and trusting environment where all colleagues are comfortable to voice their opinions
- S/He will continuously stretch themselves and the department teams’ performance and inspire all colleagues to accomplish extraordinary results.
- The Associate Director of Operational Compliance will continuously benchmark with best in class industry to challenge corporate and site thinking on best practice compliance performance.
- Interprets internal and external regulatory 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.
- Gembas 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.
- 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.
- Act as coach for all members of department in compliance. Works closely with teams to ensure that day to day activities are compliant and aligned with procedures.
- 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.
- To 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.
- Develops innovative lean compliance systems that anticipate future department needs aligned with industry best practice
- Engages with senior stakeholders (internal & external) to influence outcomes as appropriate.
- Core team member at site Quality and EHS Councils.
- 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
- Ensures compliance is at the core in development of departmental strategies.
- Departmental Tier 4 owner for Compliance
- Participate and comply with our manufacturing division Quality Management System (QMS) requirements, including ownership, as relevant.
- Responsible for driving a culture of Continuous Improvement by deploying our organization Six Sigma tools within the IPT. Model our organization 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 for.
- Direct Management responsibility for Compliance Team. Accountable for delivering on compliance projects.
The Ideal Candidate:
- >10 years’ experience in pharmaceutical industry.
- >5 years’ experience in operational leadership.
- Demonstrated technical knowledge and experience in compliance (GMP, Eng., Technical.
- Degree in (Science/Engineering). Masters would be an advantage.
- Green Belt.
- Demonstrated use of Leadership Behaviors
- Evidence of Continuous Professional Development
- Demonstrated self-motivation/direction skills with a continuous improvement focus.
- Demonstrated technical capability in EHS.
- Demonstrated ability to lead and realise improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
For further information on this Associate Director Role role in Cork please contact Orla Crowley Healy on 086 80449473/ email@example.com
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