Sr Associate, Supplier Quality
External Posting TitleSr Associate, Supplier QualityJob DescriptionJob Summary:
The main purpose of this job is to manage the QA interface with manufacturing and testing partners for commercial Bulk Drug Product/ finished products by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements. The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements.
- Responsible for quality aspects related to the transfer or set-up of processes related to commercial and clinical large molecule bulk drug products to all contract manufacturing organisations under the responsibility of Biogen Idec International, including but not limited to risk assessments, validations protocols and reports review and approval, defining and following up on quality and performance indicators.
- Manage the QA interface with manufacturing and testing partners for assigned commercial and clinical large molecule bulk drug products, ensure quality issues are appropriately investigated, tracked and resolved in a timely manner.
- Assure the timely and appropriate investigation, impact assessment, close out of deviations and investigations involving partners and contractors. Ensure appropriate corrective and preventive actions are defined, implemented and that their efficacy is evaluated.
- Ensure during Tech Transfer and routine clinical/commercial manufacturing of products that the CMOs maintain quality systems that are in the state of compliance.
- Prepare, manage and maintain quality agreements with manufacturing and testing partners for clinical and commercial products
- Participate to the preparation of annual product quality reviews.
- Perform the periodical evaluation of the performance of contract manufacturing organisations in collaboration with other concerned departments and take action as adequate.
- Participate in regulatory inspections and support regulatory inspections at CMOs. Perform risk assessments as preventive measures or in response to product/ quality system failures, investigations and regulatory inspectionsLocationZug, SwitzerlandJob CategoryOperations, Technology & Innovation (PO&T)Requisition Number29375BRQualifications- A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries
- Relevant experience in either manufacturing, development, quality or regulatory
- Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus)
- Fluent English is a must
- A minimum Bachelor degree in life science or related facultiesEducationn/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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