TriLink Biotechnologies is seeking a Manager, Supplier Quality responsible for managing all aspects of the supplier quality management function, including leading the raw materials team, to meet Quality Management System requirements. This role will ensure compliance with applicable domestic and international standards and regulation Responsibilities include:
- Work with R&D, manufacturing, and materials management on qualification of new suppliers, including identification of supplier risks and mitigation strategies, performing supplier quality audits, managing quality agreements, etc.
- Maintain supplier qualifications and approved vendor list (AVL).
- Coordinate and communicate with R&D, manufacturing, technical support, and materials management to ensure awareness of product related issues and change notifications.
- Lead the incoming raw materials team, including receipt, inspection, sampling, labeling, processing, containment, and storage of materials in appropriate locations. Manage segregation of nonconforming materials to prevent unintended use.
- Work with suppliers to resolve supplier discrepancies and supplier corrective action plans to resolve quality product or service related issues timely.
- Collect and evaluate supplier quality data. Report and present supplier performance metrics monthly and as requested.
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventative actions and effectiveness. Use of quality tools, such as FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Participate on internal audit team and support external audits.
- Work with R&D, manufacturing, quality, technical support, materials management, etc. to identify opportunities for improvement. Manage quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
- Helps train others in supplier management and other quality system processes.
- Supervise subordinate employees, including training, employee development, and performance management.
- Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
- BS Degree in scientific discipline.
- Quality professional with a minimum of 5 years experience in a supplier quality management capacity in a life science industry.
- Requires knowledge of ISO 9001, ICH Q7, 21 CFR 820, or 21 CFR 210/211.
- Strong verbal and written communication skills.
- Strong interpersonal and customer interfacing skills.
- Strong problem solving skills.
- Self-motivated and able to organize and prioritize multiple tasks.
- Identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.