Senior Quality Assurance Manager

Job Description Summary

We are looking for a proactive and well-connected colleague to join our team as a Senior Quality Assurance Manager. In this role, you will provide leadership and oversight across all quality assurance matters, ensuring that all operational activities comply with cGMP (Current Good Manufacturing Practices), applicable legal and regulatory requirements, as well as the Sandoz Quality Manual and policies. You will be accountable for ensuring that products manufactured at site, by external suppliers, and those imported for the local market are released in full compliance with Sandoz Quality Standards. Through your leadership, you will play a critical role in safeguarding product quality, ensuring supply reliability, and supporting the Sandoz purpose of expanding patient access to high-quality medicines.

Job Description

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 proactive and well-connected colleague to join our team as a Senior Quality Assurance Manager. In this role, you will be responsible for managing quality aspects at external suppliers to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Sandoz Quality Manual and is conducted according to the relevant Standard Operating Procedures.. Through your leadership, you will play a critical role in supporting the Sandoz purpose of expanding patient access to high-quality medicines.

Your responsibilities include, but not limited to:

• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined actions and goals.
• Negotiation of Quality Assurance Agreements (QAA) with external partners.
• Change and deviation management, complaint handling.
• Escalate risks and issues, as well as propose mitigating actions.
• Responsibility for ensuring timely achievement of project Quality deliverables.
• Contribute to process simplification and QMS improvements
• Responsible for external suppler qualification and routine monitoring
• Ensures site readiness for regulatory inspections and quality audits
• Stability reports and PQR’ s review and approval.
• Support Quality activities within transfers, launches and deals.
• Participate quality activities within global projects.

Role Requirements:

• Education: Advanced university degree (Master’s or equivalent) in a relevant field such as Chemistry, Pharmacy, Biotechnology, or Biology.
• Minimum of 10 years’ experience within the pharmaceutical industry, including at least 5 years in the manufacturing of sterile pharmaceutical products.
• Extensive knowledge of aseptic and sterile pharmaceutical processes and strong expertise in the manufacturing of biologics.
• At least 5 years of hands-on experience in operational Quality Assurance within a regulated pharmaceutical environment.
• In-depth understanding of cGMP requirements across major regulated markets, including the EU and US.
• Excellent communication in English and advanced negotiation skills.

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 are 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!  

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.

#Sandoz

Skills Desired

Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise