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:

 

This position supports the quality assurance organization by ensuring the sterile manufacturing facility follows EU regulation Annex 1 and other regulatory requirements. 

 

Responsibilities include but are not limited to:

Lead and manage the development and execution of a robust remediation plan to address compliance gaps identified in EU regulation Annex 1 and other relevant regulations.Collaborate with cross-functional teams, including Quality Control, Regulatory Affairs, Manufacturing, and Engineering, to assess the current state of compliance and define corrective actions.Conduct thorough gap assessments and risk analyses to prioritize remediation efforts and develop effective strategies for addressing identified compliance gaps.Design and implement sustainable solutions that align with regulatory requirements and industry best practices, while also considering operational efficiency and impact.Develop and maintain a detailed project plan for remediation efforts, outlining tasks, timelines, responsibilities, and milestones.Monitor progress and regularly report to senior management and regulatory authorities on the status of remediation activities, including successes, challenges, and potential deviations from the plan.Collaborate with internal and external auditors to facilitate compliance audits and inspections, ensuring all documentation and evidence are readily available.Provide guidance, training, and support to staff members involved in compliance-related activities, fostering a culture of compliance excellence.Stay updated on changes to regulations, guidelines, and industry trends related to sterile manufacturing and compliance, and apply this knowledge to the ongoing improvement of compliance practices.Serve as a subject matter expert in compliance matters, providing insights and recommendations to senior leadership and cross-functional teams.Design and implement sustainable solutions to track product quality and site performance metrics.Author annual product quality reviews and site performance reports.

Who You Are:

 

Minimum Qualifications:

Bachelors Degree in Pharmacy, Chemistry, or other Life Science field.  5+ years of experience in Quality Assurance and Compliance within a sterile manufacturing facility.

 

Preferred Qualifications:

 

Masters Degree in Life Science. 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