Closing Date: 01 Nov 16
Salary (£): Negotiable
Senior Associate, Supplier Quality (f/m) in Canton of Zug External Posting Title Sr Associate, Supplier Quality Job Description Job 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. ...
Senior Associate, Supplier Quality (f/m) in Canton of Zug
External Posting Title Sr Associate, Supplier Quality Job Description Job 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, 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 organizations 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 inspections Location Zug, Switzerland Job Category Operations, Technology & Innovation (PO&T) Requisition Number 29375BR Qualifications - 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)
• A minimum Bachelor degree in life science or related faculties Education n/a About Biogen Biogen (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.
• Fluent English is a must
Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to
Petra Ognjenovic: email@example.com
In case of any further question, please do not hesitate to contact Petra Ognjenovic: 0049 89 2109 4906.
Lawrence Harvey is acting as an employment agency in regards to this position.
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