Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier.
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Sandoz Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
- Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
- Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Sandoz Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
- Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Sandoz Quality Manual. Ensure investigations are correctly executed.
- Escalate any issues or instances of instability per the Sandoz escalation policy, and initiate any market action that is required. Support / participate in Sandoz Emergency Management cases as required.
- Ensure that Change requests, either from the External Supplier or from Sandoz, are managed according to the Quality Agreement and Sandoz SOPs from receipt, through to the implementation and closure.
- Performing technical visits of suppliers, issue technical visit reports and perform follow-up.
What you’ll bring to the role:Essential Requirements:
- Minimum 10-15 years of experience in handling ointments, creams and lotions dosage forms OR combination of other dosage forms.
- Critical Negotiations.
- Functional Breadth.
- Project Management.
- People Leadership.
- Collaborating across boundaries.
- Operations Management and Execution.
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Employee Performance Evaluations.
- Gmp Procedures.
- People Management.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Regulatory Exposure.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
