In Genomics, Agilent offers a broad variety of high-quality workflow solutions for various applications within genomics for translational research and more. Sample quality control (QC), next-generation sequencing (NGS) library prep and target enrichment, microarrays, CRISPR, PCR/qPCR, bioreagents, and data analysis solutions including interpretation, and reporting.

This role serves as Quality Assurance Manager for the Cedar Creek site, that manufactures and distributes products for multiple divisions in the Diagnostics and Genomics Group. The Cedar Creek site reports into the Integrated Genomics Division. Responsibilities includes but are not limited to quality operations, supplier quality, quality engineering, field actions, product investigations, document control, change control, training, non-conformances, deviations, CAPA, management review, audits, inspections, complaint investigations and post market surveillance. Serves as the Good Manufacturing Practices (GMP) quality leader for site and represents quality on site leadership team. Collaborates with similar roles in other Genomics locations responsible for manufacturing, research & development, distribution, and quality activities.

Ensures that quality products are designed and manufactured by Agilent, and are in alignment and compliance with national, regional, and global regulations, company policies and business objectives. Develops and implements programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for regulatory compliance. Oversees and directs quality and/or regulatory activities and executes key strategic programs within assigned area of responsibility.

Designs, manages, executes tactical business plan to deliver business strategy. Develops, executes multi-business programs that deliver key goals for the organization and site. Ensures metrics are established, published through dashboards and the quality management systems is assessed on a frequent basis to ensure it continues to meet its requirements and there are adequate resources assigned.

Ensures quality management system procedures are accurate and current. Provides expertise in translating regulatory requirements into practical, workable plans. Represents the company in industry associations and standards bodies and may interact with regulatory agencies. Hosts internal audits and external inspections for Cedar Creek site.

Manages the development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Manages generation and review of documentation used in good manufacturing practices (GMPs). Monitors audits of production and quality control areas and raw material vendors. Selects, develops, and evaluates personnel to ensure the efficient and effective operation of the function.

Manages quality programs for training and career development for department. Represents quality in any site related events and activities. Acts as a change agent to help establish a customer-centered culture. Serves as an internal change agent and communication point of contact for the local organization.

Responsibilities

Leadership and Management:

• Lead the quality team, providing guidance, training, and support.

• Manage resources effectively, including budgeting and scheduling.

• Foster a culture of quality, integrity, and continuous improvement.

Quality Control and Assurance:

• Develop and implement quality control systems and standards.

• Monitor and analyze quality performance across all production processes.

• Inspect and test materials, equipment, processes, and final products to ensure compliance with quality standards.

Operational Excellence:

• Drive operational excellence by identifying areas for improvement and implementing best practices.

• Collaborate with cross-functional teams to optimize processes and enhance efficiency.

Regulatory Compliance:

• Maintain a deep understanding of relevant regulations, including 21 CFR 820, ISO 13485, ISO 14971, and IVDR.

• Ensure that all quality-related activities adhere to these standards.

Customer Focus:

• Understand customer needs and requirements to develop effective quality control processes.

• Devise and review specifications for products or processes.

• Set requirements for raw materials or intermediate products from suppliers and monitor their compliance.

Reporting and Documentation:

• Prepare detailed reports by collecting, analyzing, and summarizing data.

• Track products throughout the manufacturing process to ensure correctness at each stage.

• Bachelor's degree in a relevant field (e.g., General Science, Biology, Chemistry Engineering, Quality Management, or related discipline).

• 3+ years of managerial experience in quality management.

• 5-7 years of experience in IVD, RUO and Medical Device manufacturing.

• Proficiency in operational excellence methodologies.

• Familiarity with 21 CFR 820, ISO 13485, ISO 14971, and IVDR.

• Strong analytical skills and attention to detail.

• Excellent communication and leadership abilities.

• Proficiency in using quality management tools and software

• Candidate must reside in the Austin Metropolitan area.

#LI-PK1