Job Description
We are seeking a highly skilled and experienced professional to join our global Computer System Validation (CSV) team as a Manager QA. This role will be responsible for ensuring that computerized systems meet compliance requirements in our GxP-regulated environment.
The ideal candidate will have a strong understanding of global regulations such as 21 CFR Part 820 and Part 11, ISO 13485, Annex 11, and GAMP 5. They will also have experience in data integrity, data migration, periodic reviews, risk management, change management, and access management.
Key Responsibilities
* Manage and support all validation activities for IT systems and applications to ensure GxP compliance.
* Design and improve the global validation process more efficiently by implementing agile automated validation tools and AI components.
* Identify and implement regulatory changes or digital improvements for the continuous effective development of the CSV process and CSV tools.
* Conduct risk assessments in individual business processes to minimize validation effort and ensure data integrity and compliance with regulatory standards.
* Create and maintain validation protocols, reports, and traceability matrixes according to our global SOPs and guidelines within our quality management system.
* Ensure the audit readiness of IT systems and applications and present and justify the GxP-compliant validation of computerized systems in internal and external audits.
* Work closely with Business, IT, and Quality Assurance to align validation processes and tools.
* Provide training and guidance on validation best practices and regulatory requirements.
Requirements
* A university degree in Computer Science, Engineering, nature sciences, or technical fields.
* 5-8 years of experience in a CSV position in GxP-regulated industries.
* Good knowledge of agile validation tools and automation test management.
* Basic understanding of Generative AI principles, process, and its use in software development lifecycle.
* Experience in GxP compliance with global systems such as SAP S/4HANA, Siemens MES, and Polarion, Salesforce (SFDC), Trackwise Digital, ServiceNow, MasterControl, as well as fluent using of Microsoft Office tools.
* Solution-oriented mindset as well as the ability to deal with conflicts, assertiveness, and to work independently and as part of the team.
* Strong communication skills across different departments and hierarchies in fluent English.
What We Offer
We value our employees who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe, and engaging workplace which forms the basis for high-performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of our organization.
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.