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.
We are seeking a talented and highly motivated Senior Quality Assurance Manager to join our Team Shanghai Personalis Biotechnology Co., Ltd.
This individual will be responsible for providing Quality Assurance (QA) support to our Personalis China testing laboratory operation. The successful candidate must have experience in ISO standards (ISO 15189 or ISO 13485) and GLP- and GCLP-like settings. Previous experience in dealing the Human Genetic Resources Administration of China (HGRAC). Sufficient knowledge and experience to independently operate or being delegated Quality Assurance managing functions.
- Initiates and implements Quality Management Systems (QMSs) activities as appropriate to raise the performance and quality of the organization process outcomes and offered products.
- Establish a QMS at the Personalis China that is aligned with Personalis MP QMS and GLP- and GCLP-like standards and requirements.
- Write, review and approve documentation (SOPs, protocols, technical reports, specifications, etc.) as needed.
- Designs, implements and documents procedures for process control, process improvement, testing and inspection as needed.
- Be responsible for the implementation of processes and site-specific QA strategies to ensure compliance with a GLP- and GCLP-like setting at the Personalis China.
- Support timely application/ re-application for certification or licensure documents submission if/when needed.
- Foster implementation and optimization of the document control structure and organization as well as electronic records management in coordination with the Personalis MP eQMS.
- Review and approve documents and reports to ensure compliance with different standards and licensing bodies and other agencies as needed.
- Review protocols, analytical results, and documents associated with investigations and corrective and preventive action (CAPA) plans.
- Conduct internal audits, track progress, and trend results, and properly document findings.
- Serve as quality control resource for problem identification, resolution, and continuous improvement
- Performs root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
- Collaborate with the laboratory personnel and provide daily subject-matter Quality Assurance (QA) expertise to resolve equipment calibration, qualification and process issues.
- Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
- Participate in supplier audits, specifically by monitoring vendor performance and establish criteria and rating system for critical vendors.
- Assure proper and documented training and competence of the Personalis China site.
- Interfaces with client quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
- Effectively operates with multi-disciplinary teams (e.g. wet-lab, bioinformatics, IT) and provide daily subject-matter QA expertise.
- Assure that all required QA and regulatory compliance requirements are properly executed and documented.
- Drive second-party client and third-party audits.
- Minimum education required: BS/MS in a scientific discipline or equivalent.
- Minimum experience required: 5 years’ experience in ISO standards (ISO 15189 or ISO 13485) and GLP- and GCLP-like settings.
- Proficient bi-lingual written and spoken language skills (Mandarin Chinese; English).
- Experience implementing or optimizing Quality Management System
- Auditor experience needed.
- Experience with robust document controls systems.
- Ability to effectively articulate messaging and purpose to partner with other parts of the organization.
- Experience reviewing and approving (SOPs, protocols, reports, batch records, etc.).
- Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.
- Experience in participating in deviation investigations, determining root cause, and developing corrective action plans.
- Ability to Identify technical problems and suggest resolution of the issues
Additional Skills Required
- Excellent and proficient communication skills
- Excellent organizational skills
- Results and decision driven
- Details oriented, thoroughness and accurate in performing assigned tasks
- Timely execute tasks and meet deadlines
- Ability to execute independently and as part of a team
- Proven ability to use multiple software tools
- Understanding and knowledge of statistical methods applied to QA systems preferred
- Overall technical and scientific understanding of clinical diagnostics in relation to genetic / genomic testing highly desirable
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.