Sr Associate, Supplier Quality(Delegated RP)
External Posting TitleSr Associate, Supplier Quality(Delegated RP)Job DescriptionOverview
Supply Chain Quality is an international organization committed to ensuring the availability of safe and effective Biogen medicines that meet or exceed patient requirements worldwide. This role will collaborate across functions to proactively develop best compliance practices, excellence in technical approaches, and continuous improvement processes.
• Reviews and verifies the batch release documentation according to local procedures and product specific checklists. Releases and dispositions the batches
• Develops relationship and manages the internal and external stakeholders
• Ensures compliance for materials manufactured with respect to regulatory, and GMP requirements
• Reviews and performs QA approval on release relevant documents, deviations, CAPAS, change-controls. Cooperate cross-functionally with the relevant parties for timely closure of the exceptions, and ensures required documentation is effective
• Participates as a Supply Chain Quality (SCQ) release representative on cross-functional teams and projects
• Provides advice and guidance on regulatory, and compliance question to the stakeholders
• Addresses potential gaps in processes or practices within teams, and projects. Maintains efficient and pertinent process flowLocationZug, SwitzerlandJob CategoryOperations, Technology & Innovation (PO&T)Requisition Number28773BRQualifications
• A minimum of 5 years of experience in the pharmaceutical (small molecules or biotechnology) industry
• Sound knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical trials and/or regulatory is an asset
• Good understanding of the manufacturing process. Previous plant experience is an asset
• Displays technical and/or scientific insight in the design and execution of processes and procedures.
• Strong attention to details
• Solid influential and communication skills. Ability to communicate at all levels both internally and externally
• Positive and pragmatic attitude with focus on delivery on time
• Computer literate with sound knowledge of ERP system
• Fluent English is a must, any other European language is a plus
• University degree in Life Science (Pharmacist or Engineering background preferred)Educationn/aAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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