Telephone: 086 3073779
Associate Director of Operational Compliance
Our client, a medical device company in Cork are currently looking to recruit an Associate Director of Operational Compliance Job for their site.
Primary responsibilities of the Associate Director:
- Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate.
- Is the front room lead in the Department for all corporate and external body audits (GMP, EHS and Statutory Inspections).
- Act as coach for all members of department in compliance.
- Accountable for development and deployment of visual metrics within the Department.
- 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 in the department, including development and maintenance of a proactive compliance risk register for the Department to ensure PIR.
- Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, EHS Standards, Validation 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
- Create collaboration links across site SLT to share best practices.
- Ensures compliance is at the core in development of departmental strategies.
- Departmental Tier 4 owner for Compliance
- Ensure the highest Quality, Compliance and Safety standards.
- Participate and comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant.
- Prioritisation of proposed mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process under the remit of decision maker roles and responsibilities.
Qualifications required of the Associate Director:
- >4 years' experience in pharmaceutical or Medical industry.
- >4 years' experience in operational leadership.
- Demonstrated technical knowledge and experience in compliance (GMP, Technical)
- Degree in (Science/Engineering). Masters desirable.
- Green Belt or suitable alternative in MPS
- Evidence of Continuous Professional Development
- Demonstrated self-motivation/direction skills with a continuous improvement focus.
- Demonstrated ability to lead and realise improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
For further information on this Associate Director of Operational Compliance Job role in Cork please contact Deirdre Finnerty on 086 3073779 / email@example.com
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