This position is responsible for supporting supplier changes and maintenance activities critical for ensuring GxP compliance of our existing and new manufacturing processes. This role will work with Supplier Quality, Quality Control, Category Managers, Compliance, Buyers, MSAT, Regulatory, and Suppliers to investigate and resolve supplier quality issues. The role will interface with TOPS and Corporate functions to lead and deploy supplier quality related process improvements and initiatives.
- Support qualification of new suppliers and materials/services for product launches and manufacturing process changes in order to ensure completion of project milestones
- Assess and support supplier change notifications (SCNs) and make needed changes to ASL and vendor master
- Initiate and maintain Supplier Quality Technical Agreements (QTAs)
- Assist with investigations related to raw materials/components. Work with suppliers to ensure thorough investigations and root cause analysis and monitor effectiveness of corrective actions
- Support SCAR investigations and supplier audits
- With minimal guidance, schedules and leads cross functional team through planning and execution of smaller project or defined piece of a larger project. This includes developing detailed, accurate project milestones and schedules, interfacing with Supplier Quality, Manufacturing, MSAT, QC, Regulatory, Category Managers, and Buyers to ensure successful project executions.
- Work with suppliers to apply process and capability studies and understand and evaluate material manufacturing processes
- Employ appropriate techniques and methods to successfully and independently execute/support material qualification projects. Make technical recommendations regarding material qualification projects. Identify opportunities for improving existing raw material quality and impact on the manufacturing process by using LEAN Six Sigma tools, Design of Experiments, etc.
- Attend and support Raw Material Review Board, S4, meetings and successful realization of S4 strategic objectives
- Compile supplier performance metrics, including metrics for SCHs, deviations, and other measures of supplier performance
- Support ASL and supplier quality continuous improvement initiatives
- Assist in development, implementation, and enforcement of departmental policies and practices
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin.
- Support supplier and material risk mitigation strategies and action plans
- Support CMC regulatory filings
- Other duties as assigned
- 8+ years experience in GMP regulated environment, with exhibited knowledge and proficiency working within quality systems (specifically Change Control) preferred
- Direct experience overseeing supplier performance and leading supplier quality improvements
- Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects
- Ability to comprehend technical information related to regulatory expectations
- Experience leading and successfully delivering cross functional projects
- Experience in regulatory inspections a plus
- Experience with TrackWise preferred
- BA or BS in a technical discipline (physical or biological sciences). Equivalent experience will be considered