Senior Quality Strategist for Biologics
hace 2 días
Overview
">Navigate the complexities of product quality stewardship with Novartis. As a Senior Quality Strategist for Biologics, you will be accountable for end-to-end quality stewardship of assigned Novartis biologics product(s) from late phase development to discontinuation.
">About the Role
">This key position involves major accountabilities such as:
">- ">
- Accountable for end-to-end quality stewardship (DS and DP) of assigned Novartis biologics product(s) (NBE's and biosimilars) from late phase development to discontinuation.">
- Provide expert quality guidance, technical support, and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle.">
- Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s) (NBE's and biosimilars).">
- Act as global quality lead in product-related Q escalations, recalls, and BPDR handling for product-specific quality and compliance challenges.">
Requirements
">To excel in this role, you will require:
">- ">
- 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.">
- Sound scientific, technical, and regulatory knowledge, ideally in Biotechnology; expertise in validation (process and cleaning) 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. Any additional language is a plus.">
Estimated Salary: $120,000 - $180,000 per annum
">We offer a competitive salary and benefits package to attract and retain top talent. Join Novartis and reimagine medicine to improve and extend people's lives.
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