Director, Quality Assurance

About the Role

The Director, Quality Assurance is responsible for developing and executing a quality assurance strategy to ensure product quality, regulatory compliance, and adherence to quality standards throughout the product lifecycle. The role provides strategic leadership and direction through subordinate managers and individual contributors to maintain robust quality systems, oversee release activities, manage audit processes, and drive quality culture across the organization.

• Develop and execute the comprehensive quality assurance strategy, implementing the steps needed to achieve objectives across quality systems, documentation control, batch release, and compliance operations.
• Oversee product release decisions, deviation and CAPA investigations, change control processes, validation activities, internal and external audit management, and supplier quality programs.
• Provide strategic leadership to QA functions, establishing tactical and operational plans that align QA initiatives with business strategy while managing regulatory and business risk.
• Serve as a key liaison with internal leadership, regulatory agencies, auditors, and external stakeholders to ensure product integrity and organizational compliance with FDA, ISO, GxP, and other applicable regulatory requirements.
• Lead quality assurance activities through subordinate managers and individual contributors, holding direct reports and cross‑functional partners accountable to quality standards and organizational values.
• Leverage risk management, CAPA systems, and continuous improvement methodologies (Lean, Six Sigma) to drive operational excellence and implement processes that balance regulatory compliance with business objectives, operational efficiency, and value creation.
• Utilize quality metrics, KPIs, and data‑driven decision making to achieve performance goals and compliance targets, while maintaining budget management accountability for quality assurance operations, resources, initiatives, and project schedules.

• Bachelor’s degree in a related field (or equivalent work experience in lieu of a degree).
• Proven track record of successfully managing large teams and complex projects.
• Deep knowledge of quality management systems, regulatory requirements (FDA, ISO, GxP), and industry standards with an ability to ensure organizational compliance and product integrity.
• Strong communication and influence skills to interact effectively with internal leadership, regulatory agencies, auditors, and stakeholders on quality assurance matters.
• Experience leading quality assurance functions including product release, deviation/CAPA management, change control, validation, and audit management.
• Demonstrated experience with risk management, quality investigations, and root cause analysis methodologies.

• Advanced degree (Master’s or PhD) in a related scientific or quality field.
• 10+ years of progressive quality assurance experience in regulated industries (pharmaceutical, biotech, medical device).
• Professional certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Six Sigma Black Belt.
• Experience managing regulatory inspections (FDA, EMA, or other health authorities) and external audits.
• Track record of successfully implementing or remediating quality systems in response to regulatory findings.
• Experience with electronic quality management systems (eQMS) and digital quality transformation initiatives.

• Pay Range: $ - $

• Medical, dental, and vision plans
• 401(k) with 150% match up to 6%
• Life insurance
• 3 weeks paid time off
• Additional benefits not specified

Sierra Space Corporation is an equal opportunity employer and is committed to working with and providing reasonable accommodations to applicants with disabilities.