Production Investigations Lead

Job title:

Investigation Lead

Location:

Waterford, Ireland Job type:
Onsite, Days

Contract:

23 month Fixed Term Sanofi contract

About the job Are you passionate about driving a culture of quality, safety, and continuous improvement? Sanofi is seeking an Investigation Lead to join our PFS (Pre-Filled Syringe) Operations team. In this pivotal role, you will act as a role model for our Quality & Safety culture, leading technical and product quality investigations to identify true root causes and implement effective, sustainable corrective actions.

As the responsible person for investigations within your area, you will bring technical expertise, a "right first time" mindset, and a proactive approach to error prevention - all while representing the shift team in engagements with internal and external stakeholders on product quality and safety matters.

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our
deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

• Lead technical and product quality investigations to identify true root causes and implement preventative and corrective actions that ensure zero repeat occurrences
• Complete investigations to quality standards within required time frames, meeting business needs
• Facilitate cross-functional investigations on shift using Gemba tools and act as SME for the Investigation System and associated tools
• Conduct proactive data collation, trending and analysis to identify process and system improvement opportunities, ensuring adherence to end-to-end lead times
• Drive timely closure of deviations, commitments and CAPAs; trend customer complaints to identify effective corrective actions
• Act as shift team coach and role model in collaboration with the Compliance Excellence Lead to drive a culture of compliance and continuous improvement
• Ensure resolution of and/or appropriate escalation of significant issues; participate in key decision-making in consultation with relevant stakeholders
• Provide subject matter expertise and support for systems, technologies and products
• Understand shift team supply commitments to ensure on-time completion of investigations
• Work closely with shift and process teams to ensure effective, right-first-time document design
• Support quality systems operations within assigned area, including conducting and supporting audits (internal, corporate, supplier, customer, regulatory)
• Monitor documentation right-first-time performance trends and implement effective CAPAs to prevent reoccurrence

• Knowledge of cGMP in a regulated environment
• Working knowledge of quality systems in a regulated environment
• Sterile manufacturing experience would be very beneficial
• System investigation experience
• Experience in connection to the remediation process
• Excellent accuracy and attention to detail
• Excellent interpersonal skills
• Problem solving skills

• Make your work count by supporting a company that brings life-changing treatments to millions - and is committed to doing right by patients, communities, and the planet Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what's next
• Pursue Progress.
• Discover Extraordinary.