- 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
- Act as coach for all members of department in compliance.
- To embed a culture of compliance and safety excellence within the Biologics 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.
- 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, Engineering 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.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT.
- The Associate Director of Operational Compliance who is recognized as the Compliance expert within the Department will provide strategic and operational leadership to manufacture and supply quality pharmaceutical products
- >10 years' experience in pharmaceutical industry.
- >5 years' experience in operational leadership.
- Demonstrated technical knowledge and experience in compliance
- Degree in (Science/Engineering)
- Green Belt or suitable alternative in MPS
- Demonstrated use of the Leadership Behaviours
- 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.
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