GlaxoSmithKline Supplier Quality Manager in Sacramento, California
Supplier Quality Manager
Open date:Jul 14, 2017 10:48 AM
Experience required:Not Indicated
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Basic qualifications:-Bachelors degree or equivalent in relevant subject
-Extensive knowledge of technologies used within the material / component supply base.
-Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.
-Awareness and understanding of business environment and ability to build networks with third party suppliers
-Good influencing and negotiating skills to ensure implementation of appropriate standards, specifications and agreements.
-Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.
Preferred qualifications:Experience in influencing improvement activity (especially in quality culture and GMP compliance).
In depth experience in active medical device manufacturing and quality operations.
Details:Bioelectronic medicine is an emerging scientific field, aiming to use tiny implantable devices to change precise electrical signals in nerves to treat a range of debilitating chronic diseases. Galvani Bioelectronics represents an important step change in the research and development of these medicines, combining GSK’s discovery and development expertise and deep understanding of disease biology with Verily’s world leading expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications.
At Galvani Bioelectronics, we have demonstrated the feasibility of major inflammatory, metabolic, and respiratory diseases using neuromodulation of peripheral nerves in small animals. We have convincing reason to believe that these therapies, once proven through clinical studies, will bring a new therapy modality and help reduce the prevalence of major chronic diseases. Our ambition is to help patients, and through the development of efficacious therapies, become one of the world’s largest neuromodulation companies
Effective Supplier Quality Management has been identified as being critical to the success of
Galvani. The purpose of this role is to implement Supplier Quality strategies to ensure that materials received by Galvani meet requirements and to complement business initiatives currently being or planned to be implemented within Galvani.
This role involves interface with the supply base but also provides an “inward facing” contact with designated team members to ensure effective management of supplier issues
The responsibilities of this role will be:
Adheres to Galvani’s Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Implement and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications. Establish all QMS and regulatory requirements with assigned suppliers and ensure they are met.
Develop and implement part and process qualification requirements to ensure that delivered products meet specification and quality/reliability requirements. Ensure that verification processes are trained, implemented, measured and effective.
Develop annual supplier audit schedule
Perform or manage on-site supplier audits.
Develop and maintain metrics to trend and report critical supply chain quality issues, and use them to launch timely response. Provide frequent communications and formal status reviews with senior management, QA team and others as required.
Recommend and implement supplier improvement plans. Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis.
Manage supplier corrective action requests to closure, and train internal team members on SCAR requirements.
Support development of incoming product strategy, First Article Inspections, and investigation and disposition of nonconforming materials.
Ensure contract resources are effectively managed and deliver services and products as promised, and that meet our QMS requirements.
You may apply for this position online by selecting the Apply now button.
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