Sr Quality Mgr
hace 1 semana
Job Description Summary:
As Senior Quality Manager, you will develop and drive execution of the Quality Management and Compliance strategy for the capacity expansion project on the new facility in Saragossa.
Responsible to develop the QMS for the new site, including but not limited to the new manufacturing plant design quality/operations, quality systems & laboratory design and implementation, knowledge transfer, customer validation and the capacity ramp-up (based on the market demand).
Has full responsibility to ensure that the timing and compliance objectives set up by the project team are achieved per plan.
Through outstanding communication, effective problem solving and active management of ambiguous situations, the primary deliverables for the role are to ensure medical device product safety/efficacy, and compliance with all relevant regulations and customer expectations, whilst leveraging and optimizing resource to achieve this in the most cost effective manner.
The Senior Manager, Quality Management is a member of both the project team and the global Strategic Quality teams._ A superb, wide-ranging __Quality Management_
_ career development role __with _
_BD, a global leader in Medical Technology._
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.
We are always seeking people who have a passion and commitment to join our Company on its journey to 'advancing the world of health'.
Main responsibilities
Project Management:
- Accountable for developing and executing, in conjunction with the Project Leader, the Quality strategy for Pharmaceutical Systems (PS) site located in Zaragoza, Spain.
- Accountable for collaborating with the project team and cross functional organizations in implementing the Quality strategy to ensure the project is executed in accordance with internal, regulatory and customer requirements and in alignment with the global Quality, global Operations & Business strategies.
- Responsible for project management for the Qualityrelated deliverables: design, define, and implement the site's Quality Management System, including its associated documentation, the Quality Control and Chemical & Microbiological laboratories and their requirements, equipment & processes, etc. Ensure the continuous monitoring of planning and metrics to ensure the project progresses on track. Sets regular review with project team and global Quality Management ensuring an efficient and effective issue resolution process.
- Responsible for project resource management: define and plan quality resources required to support each phase of the project. Ensure project quality resource availability on time and to the right level of quality.
- Responsible for project internal communication; ensure the right level of visibility for the project is provided within the organization and that quality issues are raised for resolution and ultimately resolved
- Responsible to hire, onboard and train local QA resources, local leadership team and talent: build and develop the quality organization & team at the new site to ensure a fully operational quality system & team is in place to drive execution. Includes the recruitment, knowledge transfer from other PS sites (BD culture, Business, Customer, and Products) and development of the right connections / network within the organization.
- Responsible to transfer product & manufacturing process knowledge, and process technologies from other PS sites as per project plans.
- Proactively identify and work through escalated obstacles that may hinder the organization and/or the project teams from focusing on and delivering their objectives.
Quality Management:
- Responsible for developing, in conjunction with Project Leader and the Senior Director, Strategic Quality the Quality Strategy and QMS for the new site.
- Responsible for developing and maintaining the quality system and compliance plans for the new site in alignment with global Quality & Business strategies.
- Accountable for the effective execution of the project and Quality strategies by prioritizing and managing people, resources, and budget to accomplish expected requirements and performance.
- Engage and provide leadership directions/objectives, coaching and personal development of project team and quality organization to perform to their best ability and meet project objectives.
- Act as "_Management Representative_" for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
- Build an influential and effective network of communication with project team and worldwide functions to ensure alignment with project priorities.
- Responsible to
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