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Director, Quality Control

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 RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US  for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development.   Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row! The Director of Quality Control (Norton)will lead an organization responsible for analytical and microbiology testing, environmental monitoring, stability testing of Drug Substance produce at the facility and assay qualification/validation of methods developed internally and externally. Oversees quality control operations to assure compliance with quality systems and all applicable regulations. Accountable for managing, coordinating, and communication of status on all QC related activities such as release/stability testing, LIR investigations, outsourcing activities. Lead organization through a large growth period from startup to production of clinical and commercial supplies at the site. Summary of Key Responsibilities Develop, establish and implement Quality Control procedures and processes to ensure success of Alnylam programs. Manage organization responsible for qualification, validation and execution of analytical methods for raw materials, and drug substance lot release and stability, environmental monitoring and in-process testing. Ensure all methods and procedures are compliant with established policies, global cGMP regulations and ICH guidelines Drive compliance with all elements of the Quality system including change controls, deviations, investigations, CAPA, and training. Deliver internal inspection readiness always for global regulatory agencies and internal auditing and serve as subject matter expert during inspections and audits Author relevant IND and NDA sections and responses to health authority inquiries and observations. Direct major laboratory investigations, including OOS, and QC related deviation investigations Develop and manage organization metrics designed to monitor performance and improve efficiencies and quality culture for the site. Provide long-term budgetary and organizational planning for the QC group in alignment Company's clinical development and commercialization plans and global expansion. Collaborate with Analytical Development team to transfer new or optimize existing assays and establish specifications Qualifications Bachelor's Degree in Analytical Chemistry or related science discipline. Advanced degree (MS, PhD) desired.  15+ years experience in a pharmaceutical or biotechnology company with  7+ years in a quality control leadership role Expert knowledge of GxP, FDA, EMA and other regional (e.g. PMDA) regulatory requirements for analytical testing Strong leader with an ability to manage and develop individuals and groups Ability to lead teams in in dynamic situations Strong verbal and written communication and presentation skills, Detail-oriented with the ability to work and lead effectively in a fast paced, multi-disciplinary team environment Effective project and time management skills   Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. TOQA20191048
Salary Range: NA
Minimum Qualification
15+ years

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