JOB DESCRIPTION

The Associate Vice President (AVP) of Global Quality for Clinical Diagnostics Division (CDD) is reporting to the Vice President of Global Quality for LDG, the Associate Vice President (AVP) of Global Quality, CDD is responsible for providing quality oversight to the Pathology, Companion Diagnostics and Genomics divisions of Life Sciences and Diagnostics Markets Group (LDG). The leader is accountable for all Quality decisions and outcomes impacting both these three divisions and executes the related workload through matrixed teams across Global Quality & Regulatory Affairs.
This position will partner with the AVP, Global Regulatory Affairs (GRA), LDG and the CDD leadership teams to ensure clinical, quality, and regulatory strategies are established, provide input to business strategies, support projects and business objectives, and oversee the execution of quality in accordance with global regulations and standards. The leader will serve as a member of the business leadership teams and will be a member of the LDG Global Quality Leadership team. The new leader will be expected to lead the newly combined team through transformation, and as such, must have strong leadership capabilities to build close business partner relationships and lead teams through change.
The scope of accountability for this position includes providing quality oversight to all research & development, design, manufacture, and distribution of products in CDD, as well as the support, maintenance, and enhancements of the products post launch. The leader must provide quality oversight to the extensive product mix of multiple classes of in-vitro diagnostic, investigation use only, and research use only products, in addition to the variety of technologies delivered under these divisions now and in the future.
The position 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.

Essential Duties & Responsibilities

• Representing Quality Assurance in Agilent internally and externally (FDA, notified bodies, authorities and third parties).
• Responsible for the maintenance, reporting of and continuous improvement of the global Quality Management System 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.
• 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, MDSAP as well as other relevant standards within area of responsibility and confirm compliant execution.
• Establish quality objectives, key performance indicators (KPIs) and action plans within global Quality to ensure compliance with all global regulations.
• Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.
• 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.
• Complaint investigations and review of complaint trending results are conducted promptly to improve the quality of Agilent distributed products. Initiates remedial, corrective, and preventive actions as required to drive down regulatory and/or customer concerns.
• Partners with Regulatory Affairs for regulatory compliance decision-making impacting the global post market surveillance requirements for all CDD products.
• Ensure a robust supplier and external manufacturer oversight process and procedures is established that meets business and regulatory expectations.
• Provides quality oversight throughout product lifecycle, including design & development, manufacturing & distribution, and product support post launch.
• Ensures the timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and modifications to existing products.
• Partners closely with Global Regulatory Affairs, ensuring products are registered in intended markets and regulatory submissions meet the project timelines.
• Stays abreast of global regulations and guidance applicable to products defined in the CDD business strategies (i.e., IVD, RUO, IUO, etc) and influences new quality and regulatory policy as science and technology advances.
• Serves on business leadership teams, working with other functional leads on strategic planning, headcount, and budget management for CDD, representing quality and regulatory.
• Team Management: Provide expertise, guidance, and training to the organization within area of responsibility. Be the role model in driving and support the continuous improvement effort. Responsible for team development, identification of the competence and profile needed, including recruitment. Mentor managers and establish a pipeline of new leaders across the organization.

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QUALIFICATIONS

• Bachelor’s degree in engineering, scientific disciplines (i.e., molecular biology, biochemistry) or other disciplines combined with related technical experience are required.
• Master’s or PhD preferred
• Minimum 8 years working in an FDA-regulated industry with experience interfacing with regulatory bodies.
• Invitro diagnostics and/or medical device industry experience required.
• Strong experience with regulatory inspections and notified body audits in a clinical and diagnostics environment, as lead representative.
• Experience with national and international regulatory registrations, submissions, and developing effective relationships with regulatory agencies.
• Experience in clinical diagnostics, tissue diagnostics, companion diagnostics, flow cytometry, bulk reagent manufacturing, anatomic & digital pathology, primary & advanced staining techniques, genomics field, specifically with qPCR, microarrays, and next-generation sequencing (NGS) technologies.
• Experience in design controls in software and instrumentation (preferred).
• Experience in bringing research-use only and in-vitro diagnostics products to market through business collaborations and regulatory/quality strategies.
• Minimum of 8 years supervisory experience managing direct reports, including hiring, training, coaching, and performance management.

ESSENTIAL SKILLS

• Ability to communicate clinical applications in diagnostics technologies with internal scientists and customers.
• Extensive knowledge of Good Manufacturing Practices (GMPs), global quality systems, and regulatory requirements and standards (ISO, MDSAP countries, EU, UK, China, etc.).
• Strong leadership skills and ability to motivate and lead teams through change.
• Proven ability to drive cultural change across an organization and influence cross-functional teams.
• Demonstrated interpersonal and relationship-building skills to lead multi-cultural and geographically dispersed teams in a fast-paced, matrixed environment.
• Lean, Six Sigma training and/or certification (preferred).

• Representing Quality Assurance in Agilent internally and externally (FDA, notified bodies, authorities and third parties).
• Responsible for the maintenance, reporting of and continuous improvement of the global Quality Management System 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.
• 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, MDSAP as well as other relevant standards within area of responsibility and confirm compliant execution.
• Establish quality objectives, key performance indicators (KPIs) and action plans within global Quality to ensure compliance with all global regulations.
• Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.
• 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.
• Complaint investigations and review of complaint trending results are conducted promptly to improve the quality of Agilent distributed products. Initiates remedial, corrective, and preventive actions as required to drive down regulatory and/or customer concerns.
• Partners with Regulatory Affairs for regulatory compliance decision-making impacting the global post market surveillance requirements for all CDD products.
• Ensure a robust supplier and external manufacturer oversight process and procedures is established that meets business and regulatory expectations.
• Provides quality oversight throughout product lifecycle, including design & development, manufacturing & distribution, and product support post launch.
• Ensures the timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and modifications to existing products.
• Partners closely with Global Regulatory Affairs, ensuring products are registered in intended markets and regulatory submissions meet the project timelines.
• Stays abreast of global regulations and guidance applicable to products defined in the CDD business strategies (i.e., IVD, RUO, IUO, etc) and influences new quality and regulatory policy as science and technology advances.
• Serves on business leadership teams, working with other functional leads on strategic planning, headcount, and budget management for CDD, representing quality and regulatory.
• Team Management: Provide expertise, guidance, and training to the organization within area of responsibility. Be the role model in driving and support the continuous improvement effort. Responsible for team development, identification of the competence and profile needed, including recruitment. Mentor managers and establish a pipeline of new leaders across the organization