Alnylam Pharmaceuticals
Senior Manager, Quality Assurance (Finance)
Overview
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 & 2018.
Under the guidance of the Associate Director of External Quality, this individual will manage Contract Manufacturing Organizations (CMOs) involved in production of drug substance on-behalf of Alnylam Pharmaceuticals, to supply clinical trials and future commercial products to all markets. In this role, the person will be responsible for ensuring Alnylam product quality at drug substance contract manufacturing operations while developing and maintaining relationships. Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with external manufacturers to ensure Alnylam quality compliance needs are met in a timely manner. This includes oversight activities such as partner selection, due diligence, establishing and maintaining quality agreements, review of change controls, deviations and metrics as well as providing support to build effective quality systems at the vendor and supporting continuous improvement activities. This individual will work closely with the CMOs, manufacturing, Quality Control, regulatory, quality systems, product quality owners, and the clinical and commercial supply chain operations teams to maintain drug product supply.
Summary of Key Responsibilities
Qualifications
Competencies
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
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