Compliance Manager, EMEA

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 analyze and test our software to ensure it adheres to current regulatory best practices and work with our Product & Engineering teams to ensure we are fully compliant. 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,and to support their audit processes 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 platforms 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, 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 audits / risk assessments by conducting semi-annual mock audits; plan for and remediates process deviations, aligning with EU 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 logs , and System QC tests that align with Pharma customers’ expectations.

Requirements

What You Have Done

• 10+ years experience with software lifecycle management, qualification, validation, and testing regimens.
• Experience with pharma- or biotech-based validation / compliance activities, preferably within EU regulatory environments.
• Experience with software development / pharma lifecycle, processes, and ecosystem, with a strong understanding of EU regulations (e.g., GDPR, specific GxP guidelines within the EU).
• Previous preparation for ISO 9001, ISO 27001, SOC 2 Type II, 21 CFR part 11 (GXP), and 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.

Originally posted on Himalayas