GxP Systems Supervisor

Posted 25 Jan 2023

Rockville, Maryland - United States

Req Id 260298

 

Work Your Magic with us!

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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 


Your Role: 


At MilliporeSigma, as the GxP Systems Supervisor, you will lead and perform a variety of tasks within the Quality Assurance department that are associated with maintaining regulatory compliance of GxP computer systems (and other business managed applications) throughout their lifecycle.  

 

  • Lead activities at your local site and support activities at other Contract Testing Services (CTS) sites, coordinating activities of both local and global GxP System Engineers and Lab System Admins for maintaining regulatory and procedural compliance for all applicable systems.
  • Direct and perform administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures. Defining, assigning, documenting and managing user access across CTS. 
  • Lead Software/System Development Lifecycle (SDLC) activities and manage Operational Technology (OT) deliverables (including but not limited to System Inventory management, Risk Assessment, Infrastructure Management, Data Classification and Protection, Data Privacy assessments and Service Level Agreements).
  • Own, manage and maintain GxP system lifecycle activities (including but not limited to Change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments and implementing controls).
  • Act as liaison with wider business and collaborate between CTS departments on all SDLC activities (including but not limited to: Validation, Change Management, Periodic Review, Decommissioning) for GxP computerized systems. Ensures transition of OT Systems from project to operations.
  • Act as liaison and interface between laboratory users, IT, OT, Engineering, Validation and external vendors in selection, implementation, and lifecycle management of business-managed systems. Responsible for maintenance plan and contracts with vendors.
  • Responsible for timely communication of status of user requests and/or system outage reporting (e.g., helpdesk tickets).
  • Works with agility and embraces and implements change on a global scale. 
  • Applies technology to drive digitalization, improve quality, and increase customer value.

 

Who You Are:


Minimum Qualifications:

 

  • Bachelor’s Degree in a scientific field (e.g., Biology, Chemistry, Microbiology, etc.) or a technical field (e.g., Information Technology, Computer Science, etc.).
  • 3+ years’ experience in a technical role supporting regulated software applications or laboratory systems.

 

Preferred Qualifications:

 

  • 5+ years’ experience in regulated (GxP) environment.
  • Understanding of GxP regulations and guidelines including but not limited to GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10.
  • Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams). 
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP).
  • Advanced knowledge and application of data integrity regulatory guidance (e.g., FDA, MHRA, WHO).


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


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