Director, Software Quality Assurance

 

POSITION SUMMARY:

The Director, Software Quality Assurance position is a hands-on role, responsible for the ownership, building, and maintenance of the software quality assurance and computer system validation programs to support Natera’s organizational objectives.  The candidate will be responsible for ensuring regulatory compliance for Software as a Medical Device (SaMD), Design Control V&V, and Validation of Natera’s Quality Systems.  Managing a team of Software Quality and Computer System Validation (CSV) professionals, this role will manage the execution of a high-paced lean validation methodology and help transition into Computer Software Assurance (CSA) where applicable.  Must have a strong background in 21 CFR 820 and ISO 13485, CSV, Design Control V&V, CAP/CLIA/NY State.

 

PRIMARY RESPONSIBILITIES:

• Oversee and manage the compliance aspects for SaMD, Design Control V&V, and Computer System Validation.
• Partner with Software Engineering to identify associated compliance gaps and oversee process improvements/remediation.
• Support the process architecture of the Computer Systems Validation (CSV) process.
• Support execution of monitoring programs to meet compliance and organizational efficiency and to ensure software compliance-related risks are managed to the appropriate level of acceptable residual risk
• Identify gaps in practices, policies, and procedures and prioritize based on current regulatory environment, guides, and regulations, and lead team to remediate or defend identified risks
• Collaborate closely with IT Infrastructure and Security teams to ensure GxP systems integrate appropriately with existing infrastructure and security architecture.
• Manage team of software QA and computer system validation professionals and ensure team is appropriately resourced

 

QUALIFICATIONS:

• BA/BS in a field related to science, healthcare, or software compliance
• 10+ years of experience managing CSV Programs in regulated industry, i.e., In-Vitro Diagnostics (preferred), Medical Device, or Pharmaceuticals
• 10+ years of experience IVD medical device industry in concentrated disciplines of R&D, Engineering Operations, Validation, and/or Quality preferred. IVD medical devices experience preferred.

 

KNOWLEDGE, SKILLS AND ABILITIES:

• Direct operational experience implementing Design Control and Validation processes globally for enterprise and local systems across GMP, GCP, PV, and/or GLP
• Demonstrated innovation, flexibility, open-mindedness, and adaptability in compliant approach to meet objectives in a rapidly changing environment with shifting priorities
• Strong experience leading cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality
• Excellent communication skills with the ability to convey information to internal and external stakeholders in a clear, focused, and concise manner
• Proven experience in managing projects and processes with ambitious milestones under pressure successfully.  Experience with Agile methodology preferred
• Demonstrate high individual effectiveness and organization skills: flexibility, communication, time-management and interpersonal skills, with high attention to detail, and experience handling multiple projects/tasks simultaneously while meeting deadlines.

 

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Duties may require working outside normal working hours (evenings and weekends) at times.
• Typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
• Travel Required for this position:  Up to 15%

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OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental