Product Quality Lead
On-site · Barcelona, Catalonia, Spain
Job Summary
Lead end-to-end quality stewardship for Novartis biologics products from late phase development to discontinuation; provide expert quality guidance, technical support and leadership for implementation of quality guidelines, regulations, standards, processes, and strategy; maintain global Quality oversight and oversee regulatory filing activities including product registration and variation management; act as global quality lead in product-related escalations, recalls and BPDR handling; drive platform-wide Q strategy harmonization and cross-functional collaboration with QC, AS&T, MS&T and ESO QA to ensure product quality throughout the lifecycle.
Required Qualifications
- 5+ years of experience in an operational GxP area in a Manufacturing/Development or Quality
- Solid knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products
- Thorough knowledge and expertise in cGMP and applicable guidelines
- Experience with validation (process and cleaning) is a plus
- Excellent and proven ability to analyze and evaluate cGMP compliance
- Proven ability to influence people and communicate in a process-oriented organization
- Fluent English, written and spoken
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