Reporting to the Vice President of Global Quality for Diagnostics and Genomics Group (DGG), the Associate Vice President (AVP) of Global Quality of the Cell Analysis Solutions Division (CLSD) is responsible for providing quality oversight to the CLSD division, is accountable for all Quality decisions and outcomes impacting the division and executes the related workload through matrixed Quality and Regulatory teams.

This position will partner with other Global Quality and Regulatory Affairs (GQRA) teams to ensure quality, and regulatory strategies are established and provide input to the CLSD businesses, support projects and business objectives, oversee the execution of quality, in accordance with global regulations and standards. The person will be a member of the CLSD leadership team. The new leader will be expected to lead CLSD Quality through on-going integration activities and business transformation, and as such, must have strong leadership capabilities and ability to build close business partner relationships.

The scope of accountability for this position includes providing quality oversight to all research & development, design, manufacture, and distribution of CLSD products, 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 research and in-vitro diagnostics, 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.

KEY RESPONSIBILITIES

• Assure a responsive organizational quality culture and customer focused team responsive to customer needs, regulatory compliance, and business operation needs. Influence the development of Quality objectives for the business and provide necessary leadership to meet them in partnership with divisional leadership team.

• 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. Mentor managers and establish a pipeline of new leaders across the organization.

• 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, in agreement with relevant global laws, regulations and standards and delivers consistent, high-quality outcomes for customers.

• Establish quality objectives and key performance indicators (KPIs) to measure the health of the quality system and continuous improvement initiatives.

• Provides quality oversight throughout product lifecycle supporting product development and validation.

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

• Ensure effective deviation handling (NCR/CAPA/Deviations), verification/validation efforts, quality control/ product release and associated quality reporting are followed.

• Ensure complaint investigations and review of complaint trending results are conducted promptly to improve quality of Agilent distributed products. Initiates remedial, corrective, and preventive actions as required to drive down regulatory and/or customer concerns.

• Partner with R&D to ensure the serviceability of all products and deliver effective training programs to service engineers.

• Partner with Regulatory Affairs for regulatory compliance decision-making impacting the global post market surveillance requirements for all CLSD products.

• Ensure robust supplier and external manufacturer oversight that meets business and regulatory expectations.

• Ensures the timely and compliant generation of validation data required to support regulatory submissions for all new products and modifications to existing products, where applicable.

• 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 CLSD business strategy and influences new quality and regulatory policy as the science and technology advances.

• As business leadership team member, working with other functional leads on strategic planning, headcount, and budget management for the CLSD divisions, representing quality and regulatory.

• Bachelor's degree in engineering or scientific disciplines (i.e., molecular biology, biochemistry), Masters or PhD preferred.

• Minimum of 8 years supervisory experience managing direct reports, including hiring, training, coaching and performance management activities

• Strong leadership skills and ability to motivate and lead teams through change.

• Proven ability to drive cultural change across an organization, working in a cross-functional environment to influence and build consensus among teams.

• Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment.

• Quality and regulatory experience in the cell biology and immunotherapies field preferred. Ability to communicate molecular biology and clinical applications in these technologies with internal scientists and customers preferred.

• Minimum 8 years working in a regulated healthcare industry and experience interfacing with regulatory bodies. Medical device and/or invitro diagnostics industry experience required.

• Experience with Good Manufacturing Practices (GMPs), global quality systems and regulatory requirements and standards for in-vitro diagnostics.

• Experience in design controls in software and instrumentation required.

• Experience with regulatory inspections and notified body audits in a clinical and diagnostics environment, as lead representative is required.

• Lean, Six Sigma training and/or certification preferred.

• Experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies preferred.

• Experience in bringing products to market faster through business collaborations and effective regulatory and quality strategies.

The preferred location for this position would be Winooski, VT or Lexington MA.

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