The Head of Quality Assurance/Regulatory Affairs (QA/RA) will be responsible for an organization of more than 80 employees centered around Pathology and Reagent Partnership divisions.

Responsibilities include the Denmark and US Quality/Regulatory organizations, which are comprised of Quality Operations, Document/Change Control, Training, Quality Management Systems Improvement, Complaint Management and Regulatory Compliance. The position resides in Agilent Carpinteria, CA and requires extensive cross-functional interaction throughout the Agilent organization, strong liaison activities with the Agilent site management teams, Agilent senior management as well as with external notified bodies and third parties including FDA and other global regulatory authorities.

• Location: Carpinteria, California

• Travel: Global travel required. 50 days per year, including monthly trips to Denmark

   

   

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

KEY RESPONSIBILITIES

• Representing QA/RA in Agilent internally and externally (FDA, notified bodies, authorities and third parties).

• Responsible for the maintenance, reporting of and continuous improvement of the global QMS within area of responsibility: Ensuring that controls are implemented and executed during operations and are aligned with global Agilent requirements. Ensure proactive and reactive voice of customer and internal feedback is incorporated into improvement measures.

• Identify access and manage quality risks or compliance concerns proactively and take immediate corrective action as required.

• Assure the quality system is applicable and in agreement with relevant laws and regulation and the FDA 820s, EU MDD, MD-IVD, ISO 9001 and 13485, Japanese PAL as well as other relevant standards within area of responsibility.

• Local execution based on local/global strategies, agreed objectives, KPIs and action plans within global QA.

• Deviation handling (NCR/CAPA/Deviations), Verification/Validation efforts, Quality Control/ Product Release and associated Quality Reporting: Assuring a responsive organizational quality culture and customer focused team responsive to customer needs, regulatory compliance and business operation needs.

• Customer Complaints Management and Safety Reporting: Responsible for the processes and handling of customer complaints of products to correct and improve quality of Agilent distributed products including global product safety reporting (MDRs/Vigilance reports, etc.). Ensures that complaints are addressed as required by global regulatory requirements, trended and driven to closure. Initiates remedial, corrective and preventive actions as required to drive down regulatory and/or customer concerns.

• Supplier Management: Assures supplier management program meets business and regulatory expectations.

• Team Management: Provide expertise, guidance and training to the organization within area of responsibility. Be the role model in driving and supporting the continuous improvement effort. Responsible for team development, identification of the competence and profile needed, including recruitment.

• Quality leadership over the development of new and/or modified products: Ensures staff is developed in antibody, software and hardware system design controls and guiding pathology organization in appropriate global regulatory requirements for product development. Participates, as required, as an independent reviewer on phase deliverables and design reviews. Assures product launches meet well-defined requirements, which include global relevant regulations and ensures regulatory associates are provided with appropriate and timely information for product submissions.

The Head of QA/RA will play an important role within Agilent's global QA function in the Pathology and Reagent Partnerships divisions. The ideal candidate is experienced in QA in regulated industries and demonstrates strong leadership capabilities. You are an engaging and convincing communicator who is used to working cross-functionally in an international organization. Lastly, the ideal candidate is a skilled relationship builder, who can collaborate and influence across functions, leveraging relationships to create alignment and affect cultural change.