Job
Description
Role Overview: Sandoz is seeking a Project Quality Management Specialist to oversee quality and validation efforts in BioPharma IT projects. In this role, you will ensure compliance with regulatory standards, drive process improvement, and provide quality support to project teams. Key Responsibilities: - Plan, execute, and assess quality activities aligned with ITQM objectives and service descriptions. - Ensure projects adhere to security and regulatory compliance requirements. - Coordinate and oversee validation efforts to meet quality standards. - Develop and implement quality/validation strategies, deliverables, and procedures. - Review and approve system documentation for completeness and stakeholder alignment. - Conduct compliance reviews against corporate and regulatory policies such as GxP and CSV. - Guide project teams on quality perspectives, mediate conflicts, and advocate for quality approaches. - Train and coach teams on quality standards and lifecycle processes to foster continuous improvement. Qualifications Required: - Bachelor's degree in computer science, Information Systems, Mathematics, Informatics, or a related field. - 3-6 years of experience in BioPharma IT Quality & Compliance departments. - Hands-on experience managing quality in international and cross-functional IT projects. - Expert knowledge of GxP, CSV, GAMP, and pharmaceutical validation requirements. - Strong understanding of IT system lifecycle phases (requirements, design, testing, deployment). - Project management skills to plan and monitor quality and security tasks. - Familiarity with Agile methodologies; DevSecOps and Six Sigma are advantageous. - Effective communication and stakeholder engagement skills across technical and non-technical audiences. Additional Company Details: Sandoz is a global leader in providing sustainable Biosimilar and Generic medicines to more than 100 countries, delivering over 900 million patient treatments in 2024. The company is committed to shaping the future of healthcare by expanding development capabilities, production sites, acquisitions, and partnerships to increase patient access to affordable, high-quality medicines sustainably. Sandoz fosters an open, collaborative culture that values diversity and personal growth, offering impactful, flexible-hybrid careers in a growth-oriented work environment. Join Sandoz to be a part of a purpose-driven organization and contribute to the advancement of global healthcare. Role Overview: Sandoz is seeking a Project Quality Management Specialist to oversee quality and validation efforts in BioPharma IT projects. In this role, you will ensure compliance with regulatory standards, drive process improvement, and provide quality support to project teams. Key Responsibilities: - Plan, execute, and assess quality activities aligned with ITQM objectives and service descriptions. - Ensure projects adhere to security and regulatory compliance requirements. - Coordinate and oversee validation efforts to meet quality standards. - Develop and implement quality/validation strategies, deliverables, and procedures. - Review and approve system documentation for completeness and stakeholder alignment. - Conduct compliance reviews against corporate and regulatory policies such as GxP and CSV. - Guide project teams on quality perspectives, mediate conflicts, and advocate for quality approaches. - Train and coach teams on quality standards and lifecycle processes to foster continuous improvement. Qualifications Required: - Bachelor's degree in computer science, Information Systems, Mathematics, Informatics, or a related field. - 3-6 years of experience in BioPharma IT Quality & Compliance departments. - Hands-on experience managing quality in international and cross-functional IT projects. - Expert knowledge of GxP, CSV, GAMP, and pharmaceutical validation requirements. - Strong understanding of IT system lifecycle phases (requirements, design, testing, deployment). - Project management skills to plan and monitor quality and security tasks. - Familiarity with Agile methodologies; DevSecOps and Six Sigma are advantageous. - Effective communication and stakeholder engagement skills across technical and non-technical audiences. Additional Company Details: Sandoz is a global leader in providing sustainable Biosimilar and Generic medicines to more than 100 countries, delivering over 900 million patient treatments in 2024. The company is committed to shaping the future of healthcare by expanding development capabilities, production sites, acquisitions, and partnerships to increase patient access to affordable, high-quality medicines sustainably. Sandoz fosters an open, collaborative culture that values diversity and personal growth, offering impactful, flexible-hybrid careers in a growth-oriented work environment. Join Sandoz to be a part of a purpose-driven organization and contribute to the advancement of global healthcare.
