Project Quality Management Specialist, Technology

4 - 8 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: Sandoz is seeking a Project Quality Management Specialist to oversee quality and validation efforts across BioPharma IT projects. In this role, you will ensure compliance with regulatory standards, drive process improvement, and support project teams from a quality perspective. Key Responsibilities: - Plan, execute, and evaluate quality activities aligned with ITQM objectives and service descriptions. - Ensure projects implement security and compliance with relevant regulations. - Coordinate and control validation efforts to meet specified quality standards. - Develop and implement quality/validation strategies, deliverables, and procedures. - Review and approve system documentation for completeness and stakeholder alignment. - Perform compliance reviews against corporate and regulatory policies (e.g., GxP, CSV). - Guide project teams on quality perspectives, mediate conflicts, and defend quality approaches. - Train and coach teams on quality standards and lifecycle processes to promote continuous improvement. Qualifications Required: - Bachelor's degree in computer science, Information Systems, Mathematics, Informatics, or 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 (requirements, design, testing, deployment). - Project management skills to plan and monitor quality and security tasks. - Familiarity with Agile methodologies; DevSecOps and Six Sigma are a plus. - Effective communication and stakeholder engagement across technical and non-technical audiences. Additional Company Details: Sandoz is a global leader in providing sustainable Biosimilar and Generic medicines. With a focus on shaping the future, Sandoz offers unique opportunities for professional and personal growth. The company's ambition is to expand access to low-cost, high-quality medicines sustainably by investing in development capabilities, production sites, acquisitions, and partnerships. If you join Sandoz, you can expect: - Flexible working arrangements - Learning and development opportunities - Exposure to global operations and cross-functional collaboration - Inclusive and growth-oriented work environment - Career advancement in a purpose-driven organization Note: Skills desired for this role include Communication Skills, Compliance Audits, Compliance Management, Compliance Risk Assessment, Compliance Training, Influencing Skills, and Quality Assurance.,

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Sandoz

Pharmaceuticals

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