About this role
Job Description Summary
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!Maintain the Quality Management Systems (QMS) for Sandoz in a compliance
state according to key international regulations and develop it to meet Sandoz
needs. Ensure design, maintenance and continuous improvement of designated. Quality System, Processes to drive standardization and harmonization further and meet compliance requirements. Ensure that design, qualification and implementation of the Quality System
related IT system meet business needs and GxP requirements following
Sandoz Quality Manual and Health Authorities expectations. Maintain knowledge with current industry trends, Health Authority expectations
and influence standards accordingly to incorporate and translate into business
processes.
Job Description
Maintain Sandoz global QMS framework compliant with key international legislations,
ensure that it supports customer expectations and Sandoz needs
Ensure design, maintenance and continuous improvement of designated Quality System, Processes to drive standardization, harmonization and simplification further and meet compliance requirements.
Maintenance of the Global Quality IT systems roadmap according to Sandoz GxP
requirements and needs. Ensure that its implementation is completed as per the plan and that Global Quality IT systems are maintained in compliant state.
Ensure that Key Quality Indicators (KQI) are maintained and reported regularly to monitor Sandoz Quality performance reporting and that there are updated according to Sandoz Leadership needs.
Oversees the maintenance, implementation and improvement of Quality Management & Governance and Third-Party Management Quality Systems, to have full compliance with GxP regulations and to meet Sandoz needs.
Lead and/or participate in key QMS projects or initiatives where needed and ensure that defined quality elements and compliance requirements are addressed and that the roll-out to impacted Functions or entities is achieved.
Maintain knowledge of current industry trends and Health Authority expectations, monitor and report trends, drive risk assessments and drive improvements initiatives.
Manage and develop Global QMS team.
Essential Requirements:
University degree in Pharmacy, Chemistry, Engineering or equivalent related discipline
Minimum 8 years’ experience in Pharmaceutical, Chemical or Biological Operations
Broad experience in QA processes and underlying regulatory requirements and industry standards/best practices
Profound understanding of QMS principles and ideally Veeva experience
Leadership and Project Management skills to ensure successful implementation of projects or initiatives
Experience in an international matrix organization
Curiosity and agility to be able to adapt to fast moving environment
Being open to doing things in new/different ways
Good communication skills
Knowledge of English
Skills Desired
Agility, Business Acumen, Business Partnering, Business Strategy,
Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing
With Ambiguity, Decision Making Skills, Employee Performance Evaluations,
Finance Acumen, GMP Procedures, Goal-Oriented, Health Authorities,
Leadership, Logical Thinking, People Management, Problem Solving Skill,
Problem Solving Skills, QA (Quality Assurance), Quality Management Systems
(QMS), Quality Standards, Self-Awareness, Smart Risk Taking
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 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, 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 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 supported!
Join us!
Skills Desired
Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, People Management, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Quality Management Systems (QMS), Quality Standards, Self-Awareness, Smart Risk Taking {+ 4 more}About Sandoz
Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.
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