Lead Investigator

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

Your Role: 

 

The Lead Investigator will oversee and conduct investigations in accordance with company policies, applicable cGMP FDA, EMA, and other global pharmaceutical regulations. Responsibilities include investigating deviations, leading root cause analysis, writing reports, and establishing CAPAs using SMART methodology.

 

Responsibilities include but are not limited to:

• Maintain oversight of the QA program from a QMS perspective, ensuring compliance and on-time closures.
• Collaborate with cross-functional teams, facilitate problem-solving, and drive continuous improvement efforts.
• Write, review, and approve Deviations, CAPAs, Complaints, as required.
• Lead and inspire cross-functional teams, fostering a culture of compliance and continuous improvement.
• Other responsibilities and projects, as assigned.
• Client facing meetings to drive timely closure of investigations.
• Investigate deviations/non-conformances of all levels: MINOR, MAJOR, and CRITICAL.
• Create SMART CAPAs and Effectiveness Checks as necessary.
• Track and trend data.

 

Who You Are:

 

Minimum Qualifications:

• Associates Degree in Microbiology, Biology, Pharmacy, or other Engineering or Life Science discipline.
• 5+ years of experience in Quality Assurance or compliance within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing environments.

 

Preferred Qualifications:

• Experience with cGMP, Data Integrity, and Quality Systems.
• Experience successfully leading and managing investigations and CAPAs.
• Experience collaborating with regulatory agencies and conducting audits or inspections.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html