Project Quality Manager - Senior Specialist

About the role

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