Investigation Lead

Biopharma Careers; Waterford; On-site; EUR 31,000 - 42,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks an Investigation Lead to join the PFS Operations team. You will lead investigations, ensuring root-cause analysis and corrective actions to prevent recurrence, while collaborating with cross-functional teams to uphold quality and safety standards.

As the responsible person for investigations within your area, you will drive proactive data analysis, support CAPA closure, and coach shift teams to maintain a culture of compliance and continuous improvement.

Qualifications

• 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.

Responsibilities

• Lead technical and product quality investigations to identify true root causes and implement preventative and corrective actions.
• Complete investigations to quality standards within required timeframes, 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.
• 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.

Skills

Root-cause investigations

Quality systems

cGMP knowledge

Data analysis

Problem solving

Interpersonal skills

Attention to detail

Leadership

Job description

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.

About Sanofi

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.

Main responsibilities

• 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 timeframes, 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

About you

• 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

Why choose us

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 .

Progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€31 200,00 - €41 600 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefit programs.