Compensation Overview

POSITION SUMMARY:

The CSV Specialist IV comes with leadership skills and managerial capabilities to support the quality system & processes of the Natera’s medical device, lab, clinical and quality software. The CSV IV works with multiple functions to conduct computerized system validation activities. This position represents compliance requirements (including 21 CFR part 11, part 820 & annex 11 compliance) related to software implementation, leads audits (internal, supplier, and external), leads CSV activities following CSV procedure.

With limited supervision works with Natera Software Engineering and cross-functional teams to ensure appropriate software documentation is in place to support computer system validation. Working with QA leadership, this position will provide value-added guidance throughout the software lifecycle. Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems. Review software change requests and maintenance updates along with associated test plans, protocols, and reports. Support internal and external audits (Part 11, 820, CLIA/CAP, ISO 13485). Support CAPA, Deviation, and Nonconformance investigation and reporting. Other duties as assigned.

RESPONSIBILITIES:

• Lead computerized system validation (CSV) activities for Lab, Product, and Quality Management software systems.
• Review software change requests and maintenance updates following change control and maintenance release process.
• Author s/w validation & test plan, protocols, report, develop software trace matrices and provide guidance on drafting requirements, specifications and procedures; perform risk based validation testing, and ensure validation state of software systems are maintained.
• Review & provide guidance on Spreadsheet validation projects.
• Support preparation and execution of s/w internal audits, s/w supplier audits as well as hosting external audits related to software.
• Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.
• Partners with leadership to implement strategies for software compliance.
• Participate in development of regulatory content for submissions to regulatory authorities.

QUALIFICATIONS

• 10+ years of work experience in Biotech industry preferred or a relevant combination of skills, education and experience
• Bachelor’s degree in life sciences, engineering, software or equivalent
• ASQ or SQA certification preferred

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to grow as a people manager, leading large, complex software validation projects, including custom software application validation.
• Knowledge of CSV procedure, GAMP 5 V model, regulatory requirements for non-product and product software (21 CFR Part 11, part 820, Annex 11, 13485, IEC 62304, 14971) to be able to respond to SQA/CSV related regulatory/compliance queries.
• Extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases.
• Good at task execution, working in agile environment, ability to work independently as well as in a team, with good communication skills.
• Preferred experience with validation of lab, clinical & quality s/w systems (e.g. LIMS, eTMF, CTMS, EDMS, etc)