Senior Supplier Quality Specialist
Personalis is a genome-scale diagnostics company pioneering genome-guided medicine. Personalis Genome Services provide clinicians and researchers accurate comprehensive end-to-end human genome sequencing and interpretation solutions in Cancer, Immune-oncology and Inherited Disease. We provide accuracy-enhanced genome sequencing assays, conducted in our state-of-the art laboratory. We analyze results utilizing proprietary databases, advanced human reference sequences, and sophisticated algorithms. Located in Menlo Park, CA, we are seeking a talented and highly motivated Sr. Supplier Quality Specialist to join our team.
The Sr. Supplier Quality Specialist will be an integral member of the Quality team. The primary responsibilities are to assist in the implementation and management of activities related to the Supplier Management Program. This individual will help drive the Quality Management System Implementation in accordance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820 and other regulations and guidance’s as applicable. The ideal candidate has knowledge and experience working in regulated environments and sufficient knowledge and experience working in Supplier Quality to operate with minimal supervision.
- Lead the implementation of Personalis Supplier Management program
- Manage the Approved Supplier List (ASL)
- Lead the evaluation and qualification activities for new supplies
- Develop, review, assess, and coordinate audit questionnaires in accordance with Supplier Management program
- Track and trend CAPS’s, NCR’s and deviation for timely completion
- Review Quality Agreement development and monitor the periodic review cycles for adherence
- Ensure supplier maintenance and periodic monitor cycles are adhered to per supplier audit schedule
- Support supplier audits as assigned
- Develop, track and trend supplier metrics for management review and actively monitor supplier quality
- Ensure execution of the supplier-initiated change notification process is timely for processing of change impact and coordination with Supply chain to manage any impact
- Support audits for licensure and accreditation documents submission
- Provide training to the organization across different teams to ensure consistency and compliance to the Supplier Quality processes and procedures
- Participate in the development, implementation and maintenance of the QMS
- Help drive continuous improvement initiatives in support of all Quality Systems
- Additional duties as assigned
Skills and Qualifications:
- Bachelor’s degree in Life Sciences (i.e. Cellular, Molecular, Biology) with a minimum of 5 years of experience managing Supplier Quality Systems
- Must be able to prepare reports for internal metrics and technical content
- Ability to compile data and critically summarize results
- Experience in authorship of standard operating procedures and related documentation
- Excellent written and verbal communication skills
- Experience in CLIA lab operations and Next Generation Sequencing platforms strongly desired
- Experience working in ISO or FDA regulated environments
- Must have proven leadership, interpersonal, and communication skills
- Strong desire to work in a demanding, high-energy, hands-on startup environment
- Expert level use of Word, Excel, and PowerPoint and experience with electronic documents management systems (EDMS)
Personalis is an Equal Opportunity Employer - Minorities, Females, Veterans and Disabilities.
Personalis offers a competitive compensation package.