Overview
TEMPORARY Quality Assurance Manager - ESO Injectables (1 year interim opportunity) in the ESO Injectables organization within STO Large Molecules & Injectables Platform. Based in the Greater Madrid Metropolitan Area.
Responsibilities
- Acts as Single Point of Contact (SPOC) for all quality related activities at the External Supplier.
- Supplier relationship management : build and maintain strong strategic relationships with suppliers, work with them on remediation plans when needed, and ensure smooth transition to a reliable status; facilitate open communication and rapid issue resolution including managing non-performance; identify and manage supplier-related risks and resolve conflicts.
- Supplier performance management : monitor and evaluate supplier performance; approve investigations for critical complaints and deviations; address signals and trends and implement measures to minimize recurrence; assess audit / inspection outcomes at suppliers and ensure robust CAPAs and timely closure; support timely launches and eliminate non-value-added tasks in interfacing QA activities with suppliers.
- Internal stakeholder management : provide visibility and updates to leadership and key stakeholders on topics impacting product quality and supply; devise action plans for quick resolution of stock-out cases; represent ESO QA in global escalation calls and apply lessons learned.
- ESO QA routine tasks : implement Supplier Qualification processes to support timely launches; support tech transfers; draft and negotiate Quality agreements; initiate audits and close Audit CAPAs; perform risk assessments during exceptions management; initiate / evaluate / close change controls; approve CQRA and APQRs.
Qualifications
Education : University Degree in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology).Fluent English mandatory.10+ years in the pharmaceutical industry with direct experience in sterile / aseptic products manufacturing / quality.Thorough knowledge of cGMP requirements for sterile / aseptic products including EU GMP Annex-1 and US FDA.Strong technical understanding of pharmaceutical processes, especially sterility assurance.Strong understanding of regulatory requirements for commercial manufacturing and risk management fundamentals.Experience in Quality Operations (QA / QC), Production or related areas; at least 5 years in QA.Experience managing key quality processes (exceptions handling, complaints, batch records reviews, QAA, QRA, APQR).Leadership and communication skills; ability to manage internal and external stakeholders; able to work in a matrix organization; drive performance improvement initiatives.Why Sandoz?
Generic and biosimilar medicines are the backbone of the global medicines industry. Sandoz aims to increase its impact through investment in development capabilities, state-of-the-art production sites, partnerships, and a culture that supports open collaboration and flexible-hybrid careers.
Commitment to Diversity and Inclusion
We are committed to an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Additional Information
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Job function : Quality Assurance
Industry : Pharmaceutical ManufacturingSeniority level : Mid-Senior levelEmployment type : Full-time#J-18808-Ljbffr