Quality System and Regulatory Specialist

IDBS helps BioPharma organizations unlock the potential of AI/ML to improve the lives of patients. As a trusted long-term partner to 80% of the top 20 global BioPharma companies, IDBS delivers powerful cloud software and services specifically designed to meet the evolving needs of the BioPharma sector.

IDBS, a Danaher company, leverages 35 years of scientific informatics expertise to help organizations design, execute and orchestrate processes, manage, contextualize and structure data and gain valuable insights throughout the product lifecycle, from R&D through manufacturing. Known for its signature IDBS E-WorkBook software, IDBS has extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments. 

IDBS is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Do you want to work in a team responsible for delivering ISO 9001and 27001 certifications and SOC; Quality Management; GxP (specifically GMP & GLP); Information Security and Data Privacy? Do you enjoy working with cross-functional teams to deliver process improvements?

We are currently seeking a Quality System and Regulatory Specialist who will be responsible for working alongside the other members of the Quality Assurance and Regulatory Affairs team to deliver the Quality & Regulatory Compliance requirements for our business in collaboration with internal and external stakeholders. This position will be based out of our office in Woking, UK.

What we’ll get you doing:

• Manage Quality and Regulatory Systems and Processes. System owner for TrackWise, including maintaining its validated status; owning and managing of QARA training requirements and associated policies and processes; supplier lifecycle management
• Tool Management and Validation: Create and execute system management and system validation processes for all relevant systems within IDBS
• Audit and Standards: Conduct and deliver assurance through internal audit programme against QMS/GxP/ISMS standards, including required monitoring and reporting; managing external ISO 9001/27001 and SOC2 Type 2 inspections; facilitating customer audits; managing responses to quality and security questionnaires.
• CAPA Management: Manage lifecycle of CAPAs, Deviations, Audit Findings transparently and in collaboration with internal departments.
• Continuous Improvement: Champion continuous improvement for Quality; GxP and Compliance processes

Here is what success in this role looks like:

• Previous experience with quality processes including CAPA lifecycle management; Internal system management and validation;
• Demonstrated knowledge of ISO 9001, 27001 and GxP requirements and implementation; Internal and external audit execution (customers and/or certification bodies).
• Knowledge of computer systems compliance within the regulated life sciences industry
• Knowledge of the software development lifecycle, particularly agile approaches such as Scrum.
• Knowledge of the Software-as-a-Service (SaaS) business model and working environment.
• Previous experience as a document management system administrator; preferably with experience as a system admin for TrackWise or Salesforce

It would be a plus if you also possess previous experience in:

• Previous experience working with SaaS products

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel within Europe and the US without Visas or travel restrictions
• Travel is expected up to 5%

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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