Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Summary
The Project Quality Manager - Senior Specialist is responsible for coordination and support quality, validation, and IT security control activities within projects, ensuring compliance with standards, effective execution, and continuous improvement under defined governance.
Major accountabilities:
- Support end-to-end quality, validation, and IT security control activities across assigned projects, ensuring adherence to GAMP5, CSV SOPs, SDZ standards, IMF, and regulatory requirements.
- Contribute to the development and execution of the quality& validation strategy, ensuring alignment with defined governance, deliverables, and project objectives.
- Support oversight and assurance activities through execution of risk-based reviews, validation checks, and security control verification to ensure completeness and compliance.
- Coordinate and monitor validation and quality execution, ensuring planned qualification/validation activities are tracked, performed, and documented appropriately.
- Ensure documentation quality and compliance, supporting the creation, review, and maintenance of validation and system deliverables in line with required standards.
- Maintain audit readiness for assigned projects, ensuring documentation is complete, traceable, and audit expectations are met.
- Provide input to project teams on quality and compliance topics, highlighting risks and supporting issue resolution.
- Collaborate with project managers and stakeholders to support quality outcomes, track escalations, and align on compliance requirements.
- Prepare and review system and validation documentation, ensuring alignment with policies, standards, and regulatory expectations.
- Support capability building by guiding teams on validation practices, documentation standards, and system lifecycle processes.
- Contribute to continuous improvement initiatives, applying fit-for-purpose and lean approaches in quality and validation processes.
- Engage with stakeholders, vendors, and suppliers to ensure consistent understanding and application of quality requirements.
Experience and Skills:
- 3-5 Years of relevant experience in BioPharma IT Quality& Compliance departments
Skills:
- ITSQM skills
- Has successfully managed quality during multiple international and/or cross- functional IT projects and/or operations and has a minimum of 3 years hands-on quality management.
- Expert Knowledge and hands-on working experience of Quality and Security Management in the following areas / disciplines GxP, CSV and GAMP·
- Good understanding of pharmaceutical validation requirements driven by health authorities like FDA etc.
- IT System Lifecycle (Requirement Management, Design, Testing, Deployment)·
- Adequate project management skills to plan quality and information security tasks and monitor their implementation during assigned projects.
- Software Development Methodologies: Agile (must have), Dev / SecOPs (good to have)
- Quality and Process Management (CMMI, Six Sigma, good to have)
- Performs a range of work, sometimes complex and non-routine, in a variety of environments.
- Applies methodical approach to issue definition and resolution.
- Has a sound generic, domain and specialist knowledge necessary to perform effectively in the organization typically gained from recognized bodies of knowledge and organizational information
Other skills
- Demonstrates effective application of knowledge.
- Has an appreciation of the wider business context
- Plans, schedules, and monitors own work (and that of others where applicable) competently within limited deadlines and according to relevant legislation, standards, and procedures.
- Contributes fully to the work of teams.
- Demonstrates an analytical and systematic approach to issue resolution.
- Takes the initiative in identifying and negotiating appropriate personal development opportunities.
- Understands how own role impacts security and demonstrates routine security practice and knowledge required for own work.
- Communicates effectively, fluently both orally and in writing.
- Can present complex information to both technical and non-technical audiences.
- Open to resolving conflicts, provide/receive feedback(s), and maintain positive work relationships.
Education:
- Bachelor's Degree (or equivalent) in Computer Science, Information Systems Management, Mathematics, Informatics, or other related fields.
- Certification or accreditation in Information Security (CISM, CISA, CISSP etc.) is a plus.
Languages:
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
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