Compliance Manager, TetraScience

• 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

Desirable

• 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