Director, Quality Assurance
7 days ago
Key Responsibilities
- Develop and implement processes for supplier qualification, performance management, and issue escalation.
- Collaborate with sourcing and purchasing teams to identify and qualify suppliers, assessing their manufacturing and technological capabilities, as well as quality and environmental risks.
- Establish global processes for business partner agreements and oversee their implementation.
- Provide proactive quality solutions for end-to-end supplier management, ensuring corresponding quality system elements are in place for quality product delivery.
- Coordinate the development and deployment of supplier quality standards, processes, and tools.
- Review and evaluate supplier quality data to ensure standard methodologies are developed and implemented, providing continuous improvements within the supply chain.
- Work with design and manufacturing engineers to define process parameters and criteria measuring supplier process capabilities and efficiency.
- Support new product launches by ensuring involved suppliers can deliver to required quality standards.
- Actively participate in supplier selection, performance management, and disengagement processes.
- Monitor supplier health authority regulatory inspection outcomes and follow-up as needed.
- Trend and analyze supplier quality and compliance issues, participating in investigations and corrective action execution.
- Oversee the Agilent Approved Supplier List (ASL).
- Establish and maintain supplier audit schedules, conduct audits, report outcomes, and monitor follow-up with all suppliers.
- Acquire and maintain current knowledge of applicable quality and regulatory requirements, ensuring quality systems in all suppliers meet current standards.
- Lead the global supplier quality team in talent management, advancing talent development and enhancing proactive supplier quality capabilities.
Qualifications
- Education: Bachelor's degree in a related field, advanced degree in engineering or a related field preferred.
- 10+ years of industry experience, with increasing managerial responsibility and matrix leadership in a life science environment.
- 5+ years of experience in 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, and other relevant regulations.
- Demonstrated ability to interface with senior executives and cross-functional teams, influence, and drive change.
- Strong leadership and team building skills.
- Experience in managing complex organizational challenges and identifying strategic initiatives.
- Ability to effectively manage multiple priorities with a sense of urgency.
- Experience in a multi-disciplinary life science environment.
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