Data Integrity Manager

Posté 23 janv. 2023

Glasgow, Glasgow - United Kingdom

Demander un identifiant 259574

 

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.

 


Your role: Based in Glasgow and reporting to the Global Director of Global Data Integrity and e-Compliance, you will provide expert advice and lead the timely implementation of policies and guidelines for Data Integrity across our contract testing, GxP business. You will act as the point of contact for both UK and APAC queries and projects. 

In this role, you will work on projects as a member of a cross functional teams as well as individual projects at a site to bring data integrity issues into compliance and guide other employees with data integrity.  Also, help ensure a continuous culture of compliance and provide the necessary direction when called upon to aid others that identified data integrity areas of concern at a site. This includes working together with quality assurance and other GxP members related to digital & business systems, advising on quality requirements for lab system administration.  In particular, leading the implementation of practices supporting the life cycle management of electronic data in a regulated environment (e.g., storage, recovery, archiving solutions).

You will help identify data integrity risks as well as help mitigate and close those risks on a data integrity roadmap.  You will deliver effective and timely execution of strategy for data integrity related concepts and processes. Collaboration with our operational sites and key stakeholders across the organization, will ensure effective oversight & escalation of data integrity issues to mitigate potential risks and drive industry/regulatory requirements.

Additionally, you will work with site leadership, specifically in relation to ensuring that there are proper SOPs to safeguard the ways of working and to share and develop best practices.

 

Who you are: 

  • Bachelors degree or equivalent, in a relevant subject.  
  • Proven experience in Quality & Compliance or closely related field within a GxP environment.
  • Ability to apply acquired knowledge to identify, analyze issues and determine root cause(s)
  • Participate in risk assessments and quality investigations
  • Ensure compliance to and advice the site teams on regulatory requirements, industry trends related to data integrity
  • Experience with CSV
  • Knowledge of ALCOA, Part 11, EU annex 11/GAMP
  • Execute data integrity compliance / gap assessments

 

Travel Requirements:

  • up to 25% travel could be required


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!

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