Manager CQA Biosimiliars
Job Description
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!Execute Clinical QA Oversight for Sandoz GCD (Biosimilar and Complex GX Programs) on the processes, development programs and clinical trials and respective Clinical Quality System to ensure compliance with the Health Authorities re-quirements, internal standards and a full adherence to the principles of patient’s safety, rights and well being, as well as data integrity, with the support of senior manager CQA.
Ensures CQA compliance evaluation activities of studies in Biosimilar BD&L in-licensed deals and Merger & Acquisitions.
Ensures CQA Biosimilar ESP oversight, ensuring risks and trends are evaluated to identify potential quality issues as well as implementation of quality standards, processes, tools, and systems used in managing external clinical service providers (ESP), with the support of senior manager CQA.
Drives a culture of quality in collaboration with GCD business for quality to be embedded in the GCD business.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Ensure the implementation of clinical quality standards in Biosimilar part of GCD business under responsibility.
- Regularly monitors the operational compliance in clinical activities and clinical studies in Biosimilars under responsibility, by executing GCP self-inspections and QA site visits (internal or external clinical sites or ESPs), as needed, with the support of senior manager CQA undefined
- Acts as CQA in revisions of Biosimilar or Sandoz harmonized SOPs as needed. Identify lessons learned relevant for Biosimilar clinical programs, and ensure knowledge sharing in appropriate forums and formats.
- Provides support for audit and inspection readiness to Biosimilar clinical programs.
- Ensures escalation of quality issues/ quality alerts as appropriate to Senior Management.
- Ensures appropriate annual program audit planning, so that ESPs and their critical subcontractors as well as investigator sites used in biosimilar clinical programs are in time audited, qualified or requalified, and audits are planned according to identified risk areas, with the support of senior manager CQA as needed.
- Executes the CQA assessment of clinical studies in Biosimilar BD&L in-licensed products and Merger & Acquisitions.
What you’ll bring to the role:
Essential Requirements:
- Graduate in Pharmacy, Life Sciences or Medical Science
- At least 8 years’ experience in GxP-regulated Clinical or pharmaceutical Operations or Quality Management.
- Good knowledge of global regulatory framework, GxP experience, knowledge of EU and FDA regulations, ICH requirements and common quality standards.
- Fundamental knowledge in pharmaceutical drug therapy (pharmaco- dynamics, pharmacokinetics).
- Experience in an international matrix organization. Good intercultural communication and negotiation skills. Analytical and organizational skills.
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, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise