Director, Quality Assurance

Sierra Space•Louisville, CO

About The Position

The Director, Quality Assurance is responsible for developing and executing quality assurance strategy to ensure product quality, regulatory compliance, and adherence to quality standards throughout the product lifecycle. This 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. The Director, Quality Assurance serves as a key liaison with internal leadership, regulatory agencies, auditors, and external stakeholders while ensuring product integrity and organizational compliance with FDA, ISO, GxP, and other applicable regulatory requirements. The Director, Quality Assurance develops and executes comprehensive quality assurance strategy, implementing the steps needed to achieve objectives across quality systems, documentation control, batch release, and compliance operations. This role provides strategic direction and leads quality assurance activities through subordinate managers and individual contributors, establishing tactical and operational plans that align QA initiatives with business strategy while managing regulatory and business risk. The Director oversees critical quality assurance functions including product release decisions, deviation and CAPA investigations, change control processes, validation activities, internal and external audit management, and supplier quality programs. This position utilizes 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. The Director leverages experience with risk management, CAPA systems, and continuous improvement methodologies (Lean, Six Sigma) to drive operational excellence and implements processes that balance regulatory compliance and quality standards with business objectives, operational efficiency, and value creation. The Director models company values and drives quality culture transformation, holding direct reports and cross-functional partners accountable to quality standards and organizational values.

Requirements

Bachelor's degree in a related field (or equivalent work experience in lieu of 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 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.

Nice To Haves

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.

Responsibilities

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