Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar 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!
Quality Assurance Manager, ESO (d/f/m)
Responsible for managing quality aspects at external suppliers for Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and Sandoz Quality Manual and is conducted according to the relevant SOPs.
Job Description
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier and drive the implementation of quality procedures, compliant processes and initiatives.
- Lead External Suppliers Qualification process, Initiate and renew QA Agreements, Supplier Quality Risk Assessments and ensure Quality auditing of External suppliers is carried out according to Sandoz Quality Manual and that all respective audit CAPAs are closed.
- Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products are in compliance with Sandoz Quality Manual and the effective Quality Agreement.
- 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.
- Manage Change Requests either from Suppliers or from Sandoz and critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and Sandoz Quality Manual. Ensure investigations are correctly executed.
- Within the organization:
- Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
- Ensure that the QA Lead and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier.
- Provide the Quality input required in Business decisions, Transfers, Launches ensuring the business continuity - Participation in the Business review of External suppliers for quality assessments and input.
- Participate in the Reporting on QA External Supplier activities - this is to include Risk Assessment, reporting and managing of defined KPI’s.
- Ensure that coordinated contact is maintained with other functions within Sandoz also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
What you’ll bring to the role:
Essential Requirements:
- Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
- Fluent in speaking / writing in English
- 5-8 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/API products.
- Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 2 years experience with sterile manufacturing.
- Thorough knowledge of cGMP requirements
- Knowledge with FDA, EMEA and other Health Authorities’ requirements.
- Strong understanding of risk assessment and risk management fundamentals/tools
- Very good Communication and negotiation skills, with definitive and authoritative decision- making ability.
- Ability to work with multi stakeholders and working in a matrix organization.
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!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €64.023,54 /year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.
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.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search | Sandoz
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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
