Director, Supplier Quality

Develop, implement, and continually improve processes, systems and tools defining the supplier quality framework and life cycle, including supplier audits and qualification, supplier performance management and issue escalation/management, supplier quality metrics program and oversight, etc.

Work with Sourcing/Purchasing in the supplier identification and qualification process, , by assessing manufacturing and technological capabilities and Quality and/or Health, Safety and Environmental risks.

Establish global processes for Business Partner Agreements and support the implementation and oversight with identified business partners (, resellers, distributors, channel partners).

Provide phase-appropriate, proactive quality solutions for the end-to-end management of suppliers, and ensure the corresponding Quality System elements are in place in order to allow for quality product to be delivered to customers.

Coordinate the development and deployment of Supplier Quality standards, processes, solutions, tools, improvement and/or remediation activities.

Review and evaluate supplier quality data to ensure standard methodologies are developed, implemented, and followed, providing for continuous improvements within the supply chain to meet quality standards that are cost-effective but also maximize customer satisfaction.

Work with Design and Manufacturing Engineers to define process parameters and criteria measuring supplier process capabilities and efficiency to meet product, process, and quality requirements.

Support new product launches by ensuring involved suppliers can deliver to the required quality standards.

Actively participate in the selection, performance management, and disengagement processes for external manufacturers and other relevant suppliers.

Monitor Supplier Health Authority regulatory inspection outcomes and follow-up, where required.

Trend and analyze supplier quality & compliance issues for common corrective and proactive preventive actions. Participate in investigations with common or category suppliers and monitor execution of corrective actions.

Oversee the Agilent Approved Supplier List (ASL).

Establish and maintain supplier audit schedule, conduct audits, report outcomes, metrics and monitor follow-up with all suppliers.

Acquire and maintain current knowledge of applicable Quality & Regulatory requirements and trends and ensure that Quality Systems in all suppliers are meeting current these standards.

Lead the global Supplier Quality team across all aspects of Talent Management (recruiting, hiring, termination, organizational design, performance management and leadership development) for all supplier quality professionals across the network.

Advance talent development and enhance proactive supplier quality capabilities through cross-sector rotations, assignments, and collaborations, while leveraging best practices.

Education: bachelor’s degree of science or related field is required, advanced degree in engineering, pharmaceutical or medical field preferred (MSc, PhD).

10+ years of industry experience, with increasing managerial responsibility and matrix leadership in a life science environment.

Experience must include 5+ years of experience with supplier quality management in a regulated environment, such as IVD, Medical Devices, Pharma, Biotechnology, or equivalent.

Expert knowledge of ISO 9001, ISO 13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211. Additional experience in the biopharmaceutical environment, ICH guidelines, etc., a plus.

Demonstrated ability to interface with senior executives and cross-functional teams, and strong proven ability to influence and drive change.

Strong leadership and team building skills.

Experience in managing complex organizational challenges and identifying and successfully implementing corporate-level strategic initiatives and priorities.

Demonstrated ability to effectively manage multiple priorities with a sense of urgency.

Experience in operating in a multi-disciplinary life science environment.

Excellent written and verbal communication skills.

Fluency in written and spoken English.