Overview We are seeking a Senior Compliance Manager to ensure TetraScience maintains regulatory compliance for customers in validated environments, with a focus on GxP, ISO 9001, and relevant EU regulations. You will collaborate with Product, Engineering, Training, and Quality teams, participate in audits, and support the GxP Package to facilitate customer validation.
What You Will Do Adhere to industry-accepted standards like GxP, ISO 9001, and relevant EU regulations to support customers\' regulated environments.
Work with Product, Engineering, and Quality teams to ensure compliance and regulatory best practices are followed.
Participate in internal and external audits and maintain the Quality Management System to support current and future certifications.
Develop, enhance, and support TetraScience\'s GxP Package, including documentation, templates, and controls for validated environments.
Collaborate with customers to address compliance questions and ensure alignment with their requirements.
Prepare for customer audits and supplier assessments by conducting internal audits and remediating deviations in line with US and international standards.
Contribute to Sales, Implementation, and Customer Engagements from an EU regulatory perspective.
Maintain and improve the Quality Management System and related documentation, ensuring alignment with evolving EU compliance frameworks.
Requirements What You Have Done 10+ years of 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 and processes, with a strong understanding of EU regulations (e.g., GxP in the EU).
Experience preparing for ISO 9001, ISO 27001, 21 CFR part 11 (GxP), Annex 11, and other relevant EU regulatory audits.
Bachelor\'s degree in computer science, physical or life sciences, or related field; strong attention to detail, accountability, ethics, and data management knowledge; ability to write and audit policies and procedures; cross-functional collaboration and influence; strong project management skills.
Preferred Qualifications Advanced degree in regulatory, quality assurance, or compliance field.
Certifications in relevant standards (e.g., Lead Auditor ISO 9001).
Experience 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 Mid-Senior level
Employment type Full-time
Job function Product Management
Industries IT Services and IT Consulting
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Location: Zollikofen, Berne, Switzerland
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