Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Sr. Supplier Quality Engineer will be an integral member of the Quality team. The primary responsibilities are to lead the development, implementation and management of activities related to the Supplier Management. This individual will help drive the Quality Management System (QMS) Implementation in accordance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820, ISO 14971 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 Supplier Management process based on risk criteria.
- Perform a periodic Supplier SOP review and amend when required.
- Manage the revision controlled Approved Supplier List (ASL).
- Lead supplier qualification activities for new supplies during applicable stages of Project design and development.
- Support other activities applicable to supplier management and controls during different stages of Project design and development.
- Lead the supplier qualification activities for new and existing suppliers regarding evaluation, monitoring and re-evaluation per the Supplier SOP.
- Develop and implement supplier continuous monitoring based on real monitoring data (Supplier Audit results, CAPAs, NCRs, Supplier Corrective Actions, Significant changes of supplier QMS processes and/or facilities, Changes to the scope of supplier responsibilities and similar).
- Develop, review, assess, coordinate and maintain all requirements of supplier qualification including audit questionnaires, ISO certifications and other applicable certifications.
- Track, trend and support closure of supplier CAPAS’s, NCR’s and deviations for timely completion per requirements of the Supplier SOP.
- Support Quality Agreements implementation, monitor the periodic review cycles for adherence and amending agreements when required,
- Define and ensure the approval of the Supplier Audit Annual Plan/Schedule.
- Ensure supplier maintenance and periodic monitoring cycles adhere to approved supplier audit Plan/Schedule.
- Lead and support supplier audits when assigned. Complete Audit Reports. Open NCR’s, CAPA (SCAR) for any audit findings. Follow up on the audit findings until completion/closure.
- Develop, track and trend supplier metrics for management review, including a summary of supplier performance effectiveness, and propose improvements.
- Ensure execution of the supplier-initiated change notification process is timely for processing of change impact. Coordination with Supply chain, quality compliance, and regulatory to assess and address any risk to safety of patient and user and performance of supplied part/service.
- 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 QMS processes.
- Additional duties as assigned
- 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/Disabilities. Personalis offers a competitive compensation package.