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 Lead quality, validation, and IT security control assurance within Sandoz projects& programs, ensuring compliance, strong governance, and continuous improvement while enabling teams to deliver compliant, high quality outcomes. Author, review& approve system documentation, ensure compliance with policies and procedures, interface with management and stakeholders, guide project teams from a quality perspective, demonstrate the value of quality products and services, train and coach teams, and drive process improvement in the quality area.
Major accountabilities:
- Own end-to-end quality, validation, and IT security control assurance across assigned programs/projects, ensuring compliance with GAMP5, CSV SOPs, SDZ standards, IMF, and regulatory requirements.
- Define and execute the quality& validation strategy, including integrated security control assurance, with clear governance, deliverables, and measurable outcomes.
- Provide independent oversight and assurance through risk-based reviews, validation assessments, and security control verification, ensuring completeness, accuracy, and compliance.
- Lead and govern validation and quality execution, ensuring all qualification/validation activities are properly planned, executed, and verified through formal reporting.
- Establish and enforce documentation standards, ensuring all system and validation deliverables meet regulatory, audit, and quality expectations.
- Ensure sustained audit readiness, maintain complete, traceable evidence and proactively identify and remediate compliance gaps and findings.
- Act as a trusted advisor to project leadership, providing clear insights on quality risks, compliance posture, and control effectiveness to support decision-making.
- Partner with project managers and stakeholders to drive quality outcomes, resolve escalations, influence decisions, and align cross-functional teams.
- Review and approve system and validation documentation, ensuring adherence to corporate policies, regulatory requirements, and quality standards.
- Build and strengthen quality capability, coaching and training teams on validation practices, system lifecycle processes, documentation, and control assurance.
- Champion continuous improvement and fit-for-purpose approaches, optimizing quality and validation processes to enhance efficiency, consistency, and control effectiveness.
- Drive stakeholder engagement across all levels, including vendors and suppliers, ensuring consistent delivery of quality products and services
Experience and Skills:
- 6-10 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 six 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)
- Interpersonal skills
- Work includes a broad range of complex technical or professional activities, in a variety of contexts
- Excels in diverse and challenging work environments, easily adapts to different contexts, and effectively handles complex technical activities
- Investigates, defines, and resolves complex issues
- Works under general direction within a clear framework of accountability
- Exercises substantial personal responsibility and autonomy
- Plans own work to meet given objectives and processes
- Influences customers, suppliers, and partners at account level
- May have some responsibility for the work of others and for the allocation of resources and should be able to mentor, monitor fellow associates
- Participates in external activities related to own specialism
- 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, and maintain positive work relationships
- Plans, schedules, and monitors work to meet time and quality targets
- Facilitates collaboration between stakeholders who share common objectives
- Fully understands the importance of security to own work and the operation of the organization
- Seeking specialist security knowledge or advice when required to support own work or work of immediate colleagues
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!
#sandoz
