About the position
Pharmaceutical concern is seeking Supplier Quality Engineer who will be responsible and accountable for the successful development, deployment, and implementation of the Supplier Quality Management (SQM) strategy and associated policies, procedures, programs and initiatives that deliver quality/compliance, cost, and/or operating benefit to the supply chain.
Actively partners with stakeholders, individuals and teams, and external suppliers to implement innovative solutions and continuous improvements with demonstrated and measurable business results.
Quality & Compliance representative in a cross-functional team responsible for Supplier Quality life-cycle projects and Product Transfer projects, including NPI/NPDs of Consumer Health products in EMEA region
Responsibilities:
Supplier selection, supplier auditing, supplier performance monitoring, supplier risk mitigation:
- Have regional quality ownership of a supplier contact and relationship, own the quality responsibility agreement between J&J and the supplier
- Manage the assigned supplier portfolio against an acceptable GMP status and risk-based approach
- Own the audit planning for the supplier and ensure timely execution and follow up
- Manage new supplier qualification and change control (selection, qualification, disengagement)
- Implement the worldwide initiatives and other quality improvements at the supplier sites
- Manage supplier quality issues (i.e. micro failures, rejects, etc.) and follow-up on-site investigations
- Support direct materials changes
- Assure a continuous improvement process of the suppliers through KPI and Management Action Plan and CAPA follow up
Business support and internal sites support:
- Build close partnership with Procurement, R&D, Raw Material Center, Global Packaging and support of Business continuity, Cost improvement projects, suppliers portfolio optimization and consolidation
- Build strong partnership with all J&J Internal manufacturing sites and support of non-conformities, material changes, inspections, quality review
Quality & Compliance Program:
- Involve into Global Quality & Compliance programs and transverse working group
- Build close partnership with regional and global quality counterparts
- Support to Suppliers Quality Management Review
- Leading on quality issues trending at the assigned suppliers to drive improvement actions
- Support to Supplier Quality Management quality system continuous improvement
Requirements:
- Scientific masters' degree (Pharmacy, Chemistry, Engineering or related field)
- Broad and deep working knowledge of the pharmaceutical drug product (preferred) or Cosmetics (or equivalent), operating functions of quality and compliance, material supply, material handling and control, product manufacturing, and product packaging
- Fluent English (spoken and written)
- Detailed understanding and application of current Good Manufacturing Practices and Agency compliance expectations
- Personal skills will be decisive: personal organization, autonomy, leadership, relational and communication skills, convictions, critical thinking, adaptability in a changing and complex environment, attention to details
- Quality culture and global mindset
- Previous experience working at a manufacturing site is preferred
- Experience working in a global and multicultural setting is preferred
- Change management and project management experience is preferred
- Exceptional written, verbal, and presentation communication skills
Please note only shortlisted candidates will be contacted
Desired Skills:
- Masters Degree
- pharmaceutical
- project management
