Quality & Compliance Lead (API), Supplier Quality Management M/F

Job Description
Quality & Compliance Lead (API), Supplier Quality Management
This position reports into EMEA Supplier Quality Lead and can be based in France, Sweden or Spain.
Who We Are
At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here .
What Will You Do
The Quality & Compliance Lead (API), Supplier Quality Management, supporting the local manufacturing site, is responsible for the Quality Lifecycle Management for the assigned API, Excipients & Chemical suppliers.
Key Responsibilities
Direct Material (DM) Supplier Quality Lifecycle Management-

• Assume ownership of the quality lifecycle management for the assigned suppliers
• Act as interface for the quality topics between the supplier & Kenvue.
• Responsible for the full quality life cycle management of assigned DM suppliers primarily comprising of following activities (not limited to)-
• Supplier selection
• Supplier Site Qualification (Onsite Audits where applicable)
• Negotiating & approving quality agreements
• Onboarding
• Change Management
• Quality Event (Non-Conformance/ Deviation) Management
• Performance Monitoring
• Disengagement
• Ensure regulatory & Kenvue requirements are implemented at the assigned DM suppliers
• Deploy continuous improvement process at the suppliers through KPI, Management Action Plan and CAPA follow.
• Feed into the regional & global supplier performance metric for the assigned suppliers
• Any other task assigned by the line manager
  

Kenvue sites & Business support-

• Establish close partnership with cross-functional team viz. procurement, R&D, Raw Material Center, Global Packaging to support of Business continuity, NPD, NPI, Cost improvement projects & other assigned projects
• Build strong partnership with Kenvue Internal manufacturing sites for supporting investigation of the quality events, supporting material changes & participating in inspections/ audits.
  

Quality & Compliance Program-

• Manage the assigned supplier’s portfolio against to applicable GMP requirement.
• Own the audit planning for the assigned supplier ensuring timely execution of the audits, follow up & closure.
• Engage in deployment Quality & Compliance programs in the region in line with the Global strategy with active engagement with the Global Teams
• Support the cross-functional supplier review governance meetings
• Support the supplier performance review with the manufacturing sites
• Develop & deploy supplier reliability program as applicable
  

Required Qualifications

• Bachelor’s degree (Chemistry, Pharmacy, or related field).
• Fluent English (spoken and written) - must have. All Applicants are requested to deliver their CV in English language.
• 5+ years of experience in a highly regulated healthcare industry e.g., Pharmaceutical, API Manufacturer with hands-on experience in deploying/ maintaining Quality Management Systems
• Experience in EU GMP product manufacturing environment
• Experience in API & Excipient Supplier Quality Management
• Good understanding of the European regulatory guidelines for Pharmaceutical Products
  

Soft Skills-

• Good team player
• Self-Driven
• Owner Mindset, take lead
• Stake holder (Internal & External) management in a matrixed environment
• Analytical Thinking & Attention to detail
  

Desired Qualifications

• Advanced degree in Chemistry, Pharmacy, or related field.
  

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
  

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
Europe/Middle East/Africa-France-Haute-Normandie-Eure
Other Locations
Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Sweden-Skåne-Helsingborg
Job Function
Quality (Generalist)
Organization
JNTL Consumer Health I (Switzerland) GmbH
Job Qualifications
What we are looking for