eCompliance Manager

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
The eCompliance Manager is responsible for providing Quality Assurance oversight, governance, and expert guidance for the validation of computerized systems (CSV) and qualification of IT infrastructure supporting GxP-regulated processes. The role ensures compliance with applicable regulatory requirements, including GxP, 21 CFR Part 11, Annex 11, and other relevant regulations, as well as adherence to the Sandoz Quality Management System, Quality Manual, and global procedures.
The eCompliance Manager serves as the primary Quality partner for technology and infrastructure initiatives, providing compliance oversight throughout the system lifecycle. This includes supporting projects and operational teams by interpreting regulatory requirements, advising on validation and qualification strategies, and ensuring implementation of risk-based and compliant solutions.

Job Description

Major accountabilities: 

• Provide Quality Assurance oversight for Computerized Systems Validation (CSV) and IT Infrastructure Qualification activities. Ensure compliance with GxP, 21 CFR Part 11, Annex 11, data integrity requirements, and Sandoz quality standards.

• Review and approve GxP-impacting changes, deviations, CAPAs, periodic reviews, supplier qualification assessments, and validation/qualification documentation.

• Support global projects and operational teams with expert guidance on validation, qualification, and compliance requirements. Review and approve key validation and qualification deliverables for computerized systems and infrastructure projects.

• Assess compliance risks and recommend appropriate mitigation strategies. Drive continuous improvement, inspection readiness, and harmonization of validation and qualification practices across the organization.

• Partner with Quality, IT, Infrastructure, and business stakeholders to ensure compliant implementation and operation of GxP-regulated systems.

Ideal Background:

Specific Professional Competencies

• Solid understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11.

• Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)

• Experience with SAP, Veeva, MES is preferable

Education:

• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent:

• Fluency in English (oral and written), additional language(s) a plus

Experience:

• 10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance.

• Solid experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.

• Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments.

• Highly experienced in the operational management of GxP solutions including its related technologies to support the operation.

• Experience in the development, implementation, and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.).

Why Sandoz? 

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. 

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.  

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!  

  

Join us, help us make healthcare fairer and faster.  

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Project Management