Role: Supplier Quality Manager
Division: Customer Channels Group / Research and Safety Division
Location: UK, France or Germany
The Supplier Quality Manager Specialist, reporting to the Vice President & General Counsel, RSD is responsible for managing the delivery of Suppliers quality requirements & strategic improvements for customers with specific focus for the Production Customers. He will execute supplier quality management strategy through coordination with the Production Program Team, Product Management, Supply Chain & Global Quality teams (e.g. quality agreements, quality certificates, change notifications, audit,..).
- Execute Suppliers on-boarding and complete Quality Agreements with suppliers
- Execute strategic improvements to quality systems regarding Suppliers Quality management processes in alignment with the Global Quality and Production program strategy and roadmap.
- In coordination with Global Quality and through collaboration with Product Management develop Key Performance Indicator to manage Suppliers and portfolio KPIs to track performance and drive Supplier compliance
- Collaborate with Product Management and key production program suppliers to drive mutually beneficial operational efficiencies utilizing process improvements tools.
- Coordinate with the Production Program, Quality and IT teams to facilitate the change notification and quality certificate processes
- Drive compliance on key customer requirements (e.g. Single/minimal lot, Certificates, Change Notices)
- Coordinate with group & corporate Quality teams to improve our quality system to address cGMP requirements (including issue management & resolution)
- Lead resolution of Quality complaints related to Products
- Support warehouse & supplier audits and response to audits
- Support Global Quality to develop and manage Quality KPIs to track performance and drive compliance
- Collaborate with Product management to growth product portfolio for the Production program
- Maintain cross-functional relationships with internal departments including Sales, Marketing, Customer Service, Supply Chain, Product Management and Production team, among others.
- Bachelor of Science or Advanced Degree in related technical or scientific field
- Relevant cGMP or cGxp experience with experience of Suppliers management
- Relevant experience of managing others in a matrix organizational structure
- Experience working in an ISO (9001 or 13485 – preferred) and/or EMEA current Good Manufacturing Practices (cGMP) production environment (medical device and/or Biopharmaceutical preferred)
- Demonstrated experience with FDA/EMEA and Notified Body Inspections
- Knowledgeable in continuous improvement methodology and related analytical tools, e.g. Six Sigma, Lean, run charts, flow charting, Pareto charts, pivot tables etc.
- Ability to develop & implement strategies and sound recommendations based on both quantitative and qualitative inputs with intuitive understanding of financial drivers.
- Skilled at root cause analysis and problem solving with a results orientation.
Non-Negotiable Hiring Criteria:
- Experienced leader or project manager of cross-functional teams.
- Experienced in supplier management processes.
- Demonstrated success with being results and proactive solution driven, with strong ability to think critically to overcome potential business hurdles to complete tasks.
- Willigness and ability to travel from 10% to 30% of the time.
- Excellent written and verbal communication skills to effectively present to all levels of an organization internally and externally and proactively work and cooperate with others department, suppliers and customers.