Vice President, Laboratory Operations

About The Role

Key Responsibilities

• Strategic Leadership: Develop and execute strategic initiatives to optimize laboratory operations, focusing on quality, capacity, TAT, and COGS.
• Operational Excellence: Lead and manage high-performing teams, ensuring accountability for customer satisfaction and achievement of departmental KPIs.
• Financial Management: Contribute to budget preparation, monitor revenue, expenses, test volume, and FTE utilization.
• Stakeholder Communication: Serve as the primary contact for delegated products, providing succinct updates to executive leadership and building effective partnerships.
• Quality and Compliance: Ensure adherence to quality programs, ISO 13485 standards, FDA requirements (CLIA and QSR), GDP, and GCP/cGMP.
• Continuous Improvement: Drive continuous improvement initiatives, implement change management, and utilize Lean Six Sigma principles.
• Talent Development: Lead, coach, mentor, and develop team members, fostering a positive and engaging work environment.
• Representation: Represent the company during audits, client visits, and technical calls, influencing internal and external policy-making

Qualifications

• BS/BA degree (or equivalent) in a STEM-related field
• Biological Sciences preferred. Minimum of 12+ years of relevant experience with a BS, 10+ years with an MS, or 7+ years with a PhD. 5+ years of experience overseeing manufacturing at a Director or Senior Manager level. Ability to travel up to 25%. Current California CLS or CGMBS license preferred. Knowledge, Skills, and Abilities: Proven track record in maintaining Quality program procedures and ISO 13485 standards. Strong understanding of FDA requirements (42 CFR 493 and 21 CFR 820). Knowledge of Good Documentation Practices (GDP) and Good Clinical/Manufacturing Practices (GCP/cGMP). Experience managing product/process nonconformities, audit corrective actions, and CAPAs. Proficient in Microsoft Office Suite, particularly Excel. Excellent written and verbal communication skills, with the ability to influence change. Exceptional organizational, time management, and problem-solving skills. Proven ability to build and manage high-performing teams. Experience providing succinct and timely program updates to leadership. Knowledge and experience with Lean Six Sigma concepts and tools, manufacturing/engineering experience, and LDT laboratory operations. 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, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com . Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information:
• BBB announcement on job scams
• FBI Cyber Crime resource page