Compliance Excellence Training Manager
BioMarin
- Cork
- Permanent
- Full-time
- Site ownership for compliance training and supporting training infrastructure
- Point of contact for Permanent Inspection Readiness and audit SME for site compliance training
- Driving the continuous improvement plan for training compliance and excellence
- Work with functional areas to analyse and document relevant training requirements and develop training plan to implement.
- Owner of metric and governance for site
- Ownership and management of Periodic Review of Curricula
- Responsible for effective internal auditing and gap closure,
- Responsibility to ensure site adapts to changing Regulatory requirements
- Development and delivery of CI Training Plan to address gaps and improve our overall training approach - utilising available technology to compliment traditional Read & Understood training
- Develop and delivery new methods, technologies and best in class training
- Responsible for the maintenance and upkeep of the wider site training matrix and manage continuous improvement of critical competency curricula, assessments and programmes.
- Build and maintain effective relationships with businesses leaders and key stakeholders, advise and support evaluation and implementation of training interventions.
- Driving standardisation and alignment across all training administration and specialist resources
- Site point of contact for the Global Training group
- Site point of contact for IBEC and peers in local companies for collaboration and benchmarking
- Partner with key stakeholder and Subject Matter Experts to design and develop specific learning solutions (for the site) using proven methodology and blended learning delivery options.
- Work collaboratively within Global Learning to implement, maintain and continuously improve site learning processes, systems and ways of working in accordance with best practice.
- Collaborate with the Bus Ops team (site and global) to apply standard work/TWI as appropriate
- Guidance on risk based approach on types of training
- Provide data and insights on learning needs and activities to inform decision making, and support the production of internal reports and qualification requirements
- Minimum 10 years of experience in industry.
- Sound knowledge of cGMPs and equivalent industry regulations.
- Experience in training and compliance.
- Must have a demonstrated track record in driving performance through self and others with knowledge of compliance systems infrastructure
- A demonstrated track record in working with GMP regulations and front of house for external inspections.
- Knowledge of relevant performance measurement tools and metrics to drive continuous improvement.