Manager, Quality Assurance, Scientific Operations

About the Role

As QA Manager, Scientific Operations, you will own quality management across the team, spanning the Sample Management and Sample Operations functions. Working in close partnership with the Natera QA team, you will be responsible for following, maintaining, and improving existing quality frameworks, compliance structures, and QA/QC systems within Scientific Operations. This role reports to the Director of Scientific Operations.

Responsibilities

• Collaborate closely with the Natera QA team to maintain and follow the Quality Management System (QMS), ensuring Scientific Operations operates in full alignment with company-wide quality standards.
• Lead the design and improvement of QA/QC processes across Scientific Operations; identify gaps in existing systems and implement practical, scalable solutions.
• Propose and drive continuous improvements to existing quality workflows, recommending changes that strengthen compliance without disrupting scientific operations.
• Serve as the primary QA contact within Scientific Operations, connecting closely with the Natera QA team and providing guidance on quality language, standards, and interpretation.
• Lead Root Cause Analysis (RCA) and CAPA processes for quality deviations, non-conformances, or audit findings.
• Train Scientific Operations staff on QA/QC expectations, documentation standards, and regulatory requirements.
• Conduct systematic spot-checks and routine audits of lab run packages, sample logs, and experimental records across Scientific Operations, including both Sample Management and Sample Operations.
• Manage the full lifecycle of SOPs, technical protocols, equipment calibration logs, and safety documents, including version control and periodic review cycles.
• Support internal and external audit readiness by maintaining organized, traceable, and audit-ready documentation systems.
• Flag non-compliant or incomplete documentation; work directly with lab staff and management to resolve gaps and implement corrective actions.
• Partner with scientific staff to enforce data-logging standards within LIMS, ensuring raw data, metadata, and reports meet quality requirements.

Requirements

• B.S. or M.S. in Life Sciences, or a related field.
• 5+ years of experience in Quality Assurance or Quality Management within a biotech, clinical lab, or diagnostics setting.
• Hands-on CAP compliance experience; familiarity with CAP inspection processes and checklist requirements.
• Familiarity with biobank regulations and certification standards (e.g., ISBER, BBMRI, or equivalent).
• Deep understanding of GLP, GxP, ISO 9001/17025 quality frameworks and their practical application in lab settings.
• Experience leading or supporting internal and external quality audits, with demonstrated ability to drive corrective and preventive actions.
• Experience at an early-stage or startup company with direct responsibility for building or significantly maturing QA/QC systems is a plus.

Skills

• Fluent in QA language and terminology; able to communicate compliance requirements clearly to both scientific and operational audiences.
• Strong technical writing skills with demonstrated ability to independently draft, revise, and finalize SOPs, work instructions, and quality documents to regulatory standards.
• Entrepreneurial mindset — comfortable building structure in ambiguous environments and proposing pragmatic solutions.
• Strong attention to detail with a rigorous, systematic approach to auditing and documentation review.
• Diplomatic and objective communication style — able to enforce compliance without stifling scientific agility.
• Able to manage competing priorities across multiple teams and stakeholders simultaneously.
• Strong written communication skills for audit findings, CAPA documentation, and regulatory submissions.

Work Environment

• Duties are typically performed in an office or hybrid office environment.
• This position requires the ability to use a computer keyboard, communicate over video conferencing platforms and telephone, and read printed material.
• Duties may require working outside normal business hours at times to support project timelines and cross-functional coordination.
• The role may involve extended periods of sitting and computer-based work.
• Travel required: Up to 10%.

Pay

Compensation Range: $55—$55 USD (base pay). Final compensation will vary based on experience, qualifications, and skills considerations.

Benefits

• Comprehensive health benefits (medical, dental, vision).
• 401(k) with company match.
• Generous paid time off and company holidays.
• Additional wellness and work-life benefits.
• Pregnancy and baby bonding leave.
• Fertility care benefits.
• Free testing for employees and their immediate families.
• Commuter benefits.
• Generous employee referral program.