Compliance Manager, EMEA

TetraScience; Ireland; Remote; EUR 80,000 - 110,000; Full time

Job summary

TetraScience is seeking a Compliance Manager to oversee regulatory compliance and enhance the Quality Management System. The role requires 10+ years of experience in compliance within EU regulated environments. Candidates should have a strong foundation in software lifecycle management and a critical understanding of quality frameworks and audits. Join a forward-thinking team that drives innovation in scientific data management solutions.

Benefits

Competitive Salary and equity

Supportive team-oriented culture

Generous paid time off (PTO)

Flexible working arrangements

Qualifications

• 10+ years experience in software lifecycle management and validation testing.
• Experience in pharma or biotech compliance in EU regulated areas.
• Strong knowledge of data management technologies.

Responsibilities

• Ensure compliance with GxP, ISO, SOC 2 Type II, and EU regulations.
• Maintain and improve TetraScience's Quality Management System.
• Prepare for customer audits and regulatory assessments.

Skills

Attention to detail

Project management

Accomplished writing and auditing

Understanding of EU regulations

Education

BS in computer science, physical or life sciences

Advanced degree in regulatory or compliance field

Job description

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Who We Are

TetraScience is the Scientific Data and AI Cloud company. We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes.

TetraScience is the category leader in this vital new market, generating more revenue than all other companies in the aggregate. In the last year alone, the world's dominant players in compute, cloud, data, and AI infrastructure have converged on TetraScience as the de facto standard, entering into co-innovation and go-to-market partnerships: Latest News and Announcements | TetraScience Newsroom

In connection with your candidacy, you will be asked to carefully review the Tetra Way letter, authored directly by Patrick Grady, our co-founder and CEO. This letter is designed to assist you in better understanding whether TetraScience is the right fit for you from a values and ethos perspective.

It is impossible to overstate the importance of this document and you are encouraged to take it literally and reflect on whether you are aligned with our unique approach to company and team building. If you join us, you will be expected to embody its contents each day.

What You Will Do

A pivotal part of that digital transformation includes adherence to industry-accepted standards like GxP, ISO 9001, SOC 2 Type II, and relevant EU regulations. The Compliance Manager will ensure TetraScience maintains its current and future offerings in a manner which supports customers' regulated and validated environments. You will work with our Product, Engineering, and Quality teams to ensure we are fully compliant and adhere to current regulatory best practice. You will participate in regular audits (both internal and external) and keep our Quality Management System current and relevant to maintain current and achieve future certifications. Additionally, you will help develop, enhance, and support TetraScience's GxP Package, which is an offering that accelerates the customer's validation through items such as documentation, templates, and assurance of controlled environments. You will also work closely with customers.

• Maintain familiarity with all TetraScience products and components in order to ensure compliance, with a specific focus on EU regulatory requirements
• Work with customers to ensure that TetraScience's Products and Platform can be adapted to their compliance and quality team's needs and requirements for both documentation and for customers to perform last mile validation of their scientific workflows that include TetraScience's products as a critical component
• Work with your peers on the Compliance team, Product, Engineering, Training, and Quality Engineering to develop, support, and promote TetraScience's GxP Package to reduce burden on pharma compliance and quality teams
• Work with TetraScience leadership to ensure that processes across the organization are consistent, automated, and enforced. Be an independent check on cross-functional Quality efforts
• Prepare TetraScience for customer audits / supplier assessments by conducting internal audits; plan for and remediate process deviations, aligning with US and international standards
• Contribute during the Sales, Implementation, and Customer Engagements process to address compliance questions from an EU regulatory perspective
• Maintain and improve our Quality Management System, ensuring adherence to evolving EU compliance frameworks
• Maintain all current compliance documentation per internal policy, including Engineering and Security Policies and SOPs, Employee training records, and validation documentation that align with Pharma customers' regulatory obligations
  
  

Requirements

What You Have Done

• 10+ years experience with software lifecycle management, qualification, and validation testing regimens.
• Experience with pharma- or biotech-based validation / compliance activities, preferably within EU regulated environments
• Experience with software development / pharma lifecycle, processes, and ecosystem, with a strong understanding of EU regulations (e.g., GxP regulations within the EU)
• Previous preparation for ISO 9001, ISO 27001, SOC 2 Type II, 21 CFR part 11 (GXP), Annex 11, and any other relevant EU regulatory audits
• BS in computer science, physical or life sciences, or related experience with:
• Strong attention to detail; sense of accountability, responsibility, and ethics
• Strong knowledge of data management technologies
• Accomplished at writing and auditing policies and procedures
• Experience working cross-functionally; understanding how to influence and change behaviors
• Strong project management skills and ability to keep non-dedicated resources on task

Preferred Qualifications

• Advanced degree in a regulatory, quality assurance, or compliance-related field
• Certifications in relevant compliance standards (e.g., Lead Auditor ISO 9001)
• Experience working with EU-based pharmaceutical or biotech companies
  
  

Benefits

• Competitive Salary and equity in a fast-growing company
• Supportive, team-oriented culture of continuous improvement
• Generous paid time off (PTO)
• Flexible working arrangements - Remote work

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management

• Industries

  IT Services and IT Consulting

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