- Maintain, create, or review standardized processes in QMS with input from Clinical Operations as it relates to execution of FDA or other health authority regulated studies for Natera-sponsored studies or where Natera is a testing lab for externally sponsored clinical trials.
- Represent Quality in cross-functional meetings with R&D, Engineering, Lab Operations, Clinical Operations, etc.
- Review trial protocols and assists in the planning and implementation of quality control processes as it relates to conduct of clinical trials.
- Participate in study document reviews (e.g., SOPs, Work Instructions, Quality Agreements, clinical study protocols, statistical analysis plans, UAT, vendor approvals)
- Work cross-functionally with other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Facilitate and guide development and completion of risk management deliverables between systems by collaboratively working with teams such as R&D, Engineering, Marketing and Clinical teams.
- Assigned lead for Clinical trials compliance activities (study start-up, study close-out, management of non-conformances, CAPA, eTMF review, complaints investigations).
- Conduct or facilitate internal and external audits of product processes and recommend improvements (e.g. Notified Body, FDA).
- Participate in CAPA, Deviation, and Non-Conformance investigation and reporting.
- Lead Risk Assessments (e.g. FMEA, Risk Analysis) with cross-functional teams on assigned clinical trial protocols.
- Participate in the management of Approved Suppliers.
- Understand and apply applicable regulations and guidance from FDA 21 CFR 50, 54, 56, 812 QSR 21 CFR 820, ISO 13485, 20916, CLIA, ICH-GCP
- Other duties as assigned
- B.S./B.A. in science, engineering, related field, or equivalent.
- Minimum of 6 years of experience in Quality process improvement in FDA 21 CFR 812, 820, GMP/GLP/GCP/HIPAA environment with medical devices, CLIA laboratory, or Life Sciences industry.
- Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields in a quality role preferred.
- Strong knowledge of Risk Management principles as it applies to execution of clinical trials using medical devices.
- American Society of Quality certifications (CQE, CQA, CQIA) and/or Association of Clinical Research Professional (ACRP, CCRA, CCRC) or Six Sigma preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
- Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects preferred.
- Proficiency with Google: Sheets, Docs, Gmail, Slides, MS Word, Excel, PowerPoint, etc.
- Experience with clinical EDC, Data Management, and LIMS systems
- Familiarity with the organization and structure of the Trial Master File (TMF)
- Familiarity with bio sample management, sample processing, and biobanking best practices
- Competency in SOPs, ICH-GCP, FDA Regulations [21 CFR Part 11, 50, 54, 56, 812, 820] ISO 13485, 20916
- Demonstrated ability to work independently and lead projects
- Demonstrated attention to detail and ability to identify quality problems and propose solutions
- Strong interpersonal skills and communication skills (both written and oral)
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Duties typically performed in an office setting.
- Must be able to sit or stand for long periods of time.
Travel required for this position:
- No ☐ or Yes ☒ : If yes state anticipated percent for travel: up to 15%