Agilent is the premier laboratory partner for a better world. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at agilent.com.
Post: Order Fulfillment Senior Quality Director
Job Description:
In this role, the person is responsible for manufacturing and supply chain quality processes and other and activities, which result in robust and improved product quality and effective quality processes and systems. The Senior Quality Director provides strategic and most importantly operational quality leadership for the Agilent manufacturing and supply chain sites across the world.
Areas of focus include:
• QA & Compliance;
• QMS Management;
• Quality Control & Metrics;
• Cost of poor quality
RESPONSIBILITIES
• Ensure manufacturing and supply chain procedures and systems comply with manufacturing specifications, relevant product regulations by effective leadership of the Order Fullfillment and Supply Chain (OFS) organzation and across the business-based quality/regulatory organizations;
• Partner with other functions in OFS, corporate and the business groups to ensure product/process transfer and changes are validated and documented in a compliant manner. Ensure that global regulatory requirements are documented and met;
• Maintain QA/RA oversight of the entire product life cycle management process in partnership with business and corporate based quality/regulatory organizations, R&D and Marketing. Provide resources, guidance and support that ensure quality standards are fulfilled throughout the new product development and introduction;
• Act as the Global process owner for processes such as the Non - Conforming Material process, Manufacturing Engineering Alert process, Engineering Change Order process, Documentation Management process, Calibration processes, DEFOA process, and Supplier Quality processes etc.. As process owner, monitor and measure the effectiveness of the processes and implement changes to improve their effectiveness or efficiency;
• Drive global improvement initiatives based on quality and regulatory strategies and ongoing quality operations in manufacturing and supply chain;
• Set clear, defined, best practice company policy and guidance on quality, ensuring compliance with regulatory requirements, and consistency of approach across the company
• Drive competitive advantage by leading Agilent’s effort to develop and implement global quality methods through more consistent operational infrastructure of our systems, processes, and resources
• Partner with business leaders in establishing world-class systems that deliver competitive advantage, enable ongoing cost reduction, and concurrent business growth
• Manage a common manufacturing quality approach and metrics that correct and improve global quality of material, products and processes. Drive ongoing improvement in the use of the Global Quality Management System;
• Collaborate with corporate and business teams on risk management processes, process flows, material controls etc.;
• Support regulatory inspections, product recalls and field corrective actions as required.
• Supports the business on enabling global quality initiatives Manage Audits (internal and external)
Candidate Profile:
• Bachelor’s degree in Engineering or Life Sciences discipline. Advanced degree highly desirable;
• Excellent knowledge of Quality Management and of Regulatory Compliance. Experience of integrating these with Excellence programs such as Lean, Six Sigma, together with the associated culture change
• Requires strategic vision, business skills, and proven leadership in developing, implementing, and supporting innovative business solutions across the Agilent Group
• Requires a comprehensive knowledge of leadership and management principles, strategic planning, project management and roll-out processes and systems
• Strong knowledge of quality management systems and Quality System Standards, including but not limited to ISO quality standards, and QSR (ISO 13485, FDA CFR 21 Part 820);
• Experience in managing QA/QC for Medical device manufacturing.
PERSONAL CHARACTERISTICS
• Exhibits change agent behaviors that bring global intensity to drive and institutionalize the future QA/RA culture within OFS;
• Visionary thinker with a desire to excel and inspire others;
• Strong communicator;
• Confident and out-going personality;
• Excellent influencing and facilitation skills;
• Persistence in face of resistance;
• Possess entrepreneurial skills in terms of innovation and problem-solving
• Have the ability to build strong working relationships across many different functions
• Good business acumen;
• Pragmatic and business oriented;
• Able to identify and focus on the key priorities;
• Self-starting, self-reliant, courage of conviction;
• Passionate, enthusiastic and able to inspire others to drive results;
• Willing to travel globally on a regular basis.
Additional Information:
Location: Americas Asia Pacific Europe
Requisition: 2065110
Industry Type: Pharma/ Biotech/Clinical Research
Job Category: Quality/Regulatory
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