Compliance Excellence Training Manager
Description
Who We Are
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Compliance Excellence Training Manager - Ringaskiddy, Cork (hybrid role 3 days onsite)
Closing date for applications: Friday 15th March 2024
The Business Operations team is dedicated to evolving Shanbally’s operational excellence journey, leading change and driving the Site Training strategy.
The Role:
This role is a key role in the wider BioMarin leadership team. The Compliance Excellence Training Manager has overall responsibility for ensuring the site meets the regulatory and compliance standards for training and manages the execution of an CI plan to evolve our training infrastructure, processes and technology in line with best in class.
The Manager will work cross functionally with leadership across the Shanbally site.
The core responsibilities include:
- 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.
Routine Activities
- 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
Improvement Responsibilities
- 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
BusOps Team Player
The Compliance Excellence Training Manager will work in collaboration with BusOps team members to reinforce he site culture of inclusion and teamwork.
This role will be responsible for managing and leading the compliance Training Specialists and driving cross-functional collaboration with Site Department Training Administrators.
Other duties as assigned.
Skills and Experience
- 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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.