Project Quality Management Specialist, Technology

6 years

0 Lacs

Posted:3 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Purpose

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us—the future is ours to shape!


We are looking for a Project Quality Management Specialist to coordinate and control quality and validation efforts across BioPharma IT projects. This role ensures compliance with regulatory standards, drives process improvement, and supports project teams from a quality perspective.



Your responsibilities include, but are not limited to:

  • Plan, execute, and evaluate quality activities in alignment with ITQM objectives and service descriptions.
  • Ensure assigned projects implement security and compliance with applicable 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, ensuring completeness and stakeholder alignment.
  • Perform compliance reviews against corporate and regulatory policies (e.g., GxP, CSV).
  • Guide project teams from a quality perspective, mediate conflicts, and defend quality approaches.
  • Train and coach teams on quality standards and lifecycle processes, promoting continuous improvement.

What you’ll bring to the role:

Essential Requirements:

  • 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.


Essential Skills:

Analytical, systematic, and process-driven approach with strong influencing and compliance capabilities.

Languages:

Fluent in written and spoken English.

Desirable Requirements:

  • Certification in Information Security (e.g., CISM, CISA, CISSP).
  • Experience with quality and process management frameworks (e.g., CMMI, Six Sigma).


You’ll receive:

  • 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


Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024. While we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, 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 is powered by an open, collaborative culture driven by our talented and ambitious colleagues. In return for applying their skills, they experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and personal growth is supported.

Join us!



Skills Desired

Communication Skills, Compliance Audits, Compliance Management, Compliance Risk Assessment, Compliance Training, Influencing Skills, Quality Assurance

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Pharmaceuticals

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