**Considering candidates in San Mateo, Santa Barbara, or US-based remote**

Evidation Health is a new kind of health and measurement company that provides the technology and guidance to understand how everyday behavior and health interact. The volumes of behavior data generated from wearables and smartphones has opened up new ways to analyze individuals’ behavior and health in real time. With a virtual pool of 3 million research participants, Evidation Health undertakes research for innovative biopharma and healthcare companies to transform how diseases are identified, treated, and monitored. 

The Systems Software Quality Assurance Lead is a new role for Evidation.  Reporting into the Director of Quality & Regulatory, this role serves the critical function of leading and coordinating the independent QA oversight of software tool validation, change control, and quality assurance process improvements. This position requires familiarity with software development practices under regulatory requirements such as GCP, 21 CFR Part 11, CCPA and HIPAA. This is a sole contributor position.

Your primary responsibilities are 1) to provide QA support, review, and/or approvals of documents and records generated by risk-based processes such as CAPA and Change Control; 2) to work cross-functionally with Evidation functional teams and our customers to develop efficient and effective software tool validation strategies and processes; and 3) to oversee software tool and platform validation efforts to establish and maintain a validated state.

RESPONSIBILITIES

• Review proposed change control documentation packages to evaluate risk, determine necessary Quality Assurance activities, and monitor completion.
• Oversee initial validation of software tools (Off-the-Shelf and configurable Software as a Service systems, for software directly related to regulatory compliance) by supporting definition of user requirements and software validation plans, reviewing software testing results, and approving completed software validation packages.
• Support evaluation of vendor software changes to ensure Evidation maintains a validated state for applicable software tools, proposing re-validation efforts when appropriate.
• Support validation efforts for Data Platform, Study Platform, and Bridge Services.
• Support definition of a baseline for software development practices across the company, in line with ISO 9001 requirements for product development.
• Evaluate QA processes to identify opportunities for streamlining and improving efficiencies for Part 11 and non-Part 11 compliant studies.
• Support evaluation of CAPA effectiveness for software quality-related CAPAs
• Identify common cross study quality issues and work with the Study Implementation and Engineering teams to plan and build long term solutions into the product platforms.

QUALIFICATIONS

Minimum Qualifications:

• 10+ years working in GxP quality assurance, with at least 6 years in software quality
• Familiarity with software development and testing processes
• Hands-on experience with Quality Management System processes such as Corrective and Preventive Action and Change Control in a GxP environment
• Experience defining and/or approving software tool validation documentation 
• Experience in operating and/or testing in compliance with 21 CFR 11, HIPAA, and/or CCPA regulations
• Extreme detail orientation
• Outstanding written communication skills: comfortable creating detailed documentation from a blank page with minimal oversight that will satisfy Regulator and Customer expectations
• Strong oral communication skills: able to analyze disparate information, create a summary or hypothesis, and discuss with a broad audience
• High degree of intellectual curiosity 
• Action orientation and demonstrated ability to own problems and propose realistic, meaningful solutions
• Bachelor’s degree

Preferred Qualifications:

• Familiarity with software validation procedures in medical device or pharmaceutical industries, including validation for 21 CFR Part 11
• Experience working in a clinical study compliance capacity or in regulated product usability and validation testing
• Hands-on document review and approval experience for FDA or IRB submissions
• Familiarity with ISO 13485 or ISO 9001
• Experience working in a fast paced and often ambiguous environment
• Comfortable facilitating and influencing cross-functional discussions, and driving to group consensus
• Consulting or client services experience - familiar with satisfying numerous customers with diverse expectations
• Master’s degree

ABOUT EVIDATION

Evidation measures health in everyday life and enables anyone to participate in groundbreaking research and health programs. Built upon a foundation of user privacy and control over permissioned health data, Evidation's Achievement platform is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Guided by our mission to enable and empower everyone to participate in better health outcomes, Evidation is working to bring people individualized, proactive, and accessible healthcare—faster.

OUR VALUES

• Put individuals first
• Challenge each other and state your good intent
• Go fast while maintaining quality and integrity
• Work to win together

OUR BENEFITS & PERKS

• Competitive salary + performance bonus + equity
• Medical, dental, and vision benefits with generous company contribution
• Company-provided life and disability insurance
• 401(k) with company contribution
• Wellness and wearable device reimbursements, mental health benefits, wellness programs
• Employee advisory committee focused around diversity, equity, inclusion, and belongingness
• Distributed teams and flexible work hours
• Take time when you need it: 13 paid company holidays + flexible time off
• Paid parental leave
• Mobile phone, home internet, and home office furniture reimbursements
• Apple laptop and your choice of monitor + noise cancelling headphones
• LinkedIn Learning and other professional growth opportunities

EVIDATION HEALTH VALUES DIVERSITY AND IS COMMITTED TO EQUAL OPPORTUNITY FOR ALL PERSONS WITHOUT REGARD TO RACE, COLOR, CREED, RELIGION, MARITAL STATUS, AGE, NATIONAL ORIGIN OR ANCESTRY, POLITICAL ACTIVITY OR AFFILIATION, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION INCLUDING GENETIC CHARACTERISTICS, MARITAL STATUS, SEXUAL ORIENTATION, GENDER IDENTITY, SEX OR GENDER.