Associate Director Quality Performance and Systems - Legal; Risk & Compliance

Associate Director, Quality Performance and Systems - Legal; Risk & Compliance

Location: US Remote - East Coast Time Zone

About Us:

Signant Health is committed to delivering excellence in clinical trials through innovative, patient-centric solutions. We are seeking an experienced Associate Director, Quality Performance and Systems, to lead and optimize our Quality Management System (QMS) and ensure the highest standards of product and process performance.

Role Purpose:

The Associate Director, Quality Performance and Systems, will be responsible for managing and enhancing the QMS infrastructure at Signant Health. This role will lead cross-functional teams, drive process improvements, and support strategic decision-making by providing comprehensive reports and analysis on QMS performance.

Key Responsibilities:

• Maintain and optimize the QMS infrastructure, focusing on document management, training, metrics, process improvements, and risk management.
• Analyze key performance indicators (KPIs) and present detailed reports and recommendations to leadership.
• Lead cross-functional meetings to review QMS performance and drive system enhancements.
• Manage the configuration and utilization of the QMS application, collaborating with IT and vendors as needed.
• Develop and assign QMS training programs for staff at all levels to ensure organization-wide competency.
• Champion the implementation of new QMS tools and processes, providing guidance to colleagues.
• Support customer audits as a subject matter expert in areas like Document Management, Training Compliance, and Quality Management Review.
• Serve as the primary point of contact for QMS-related inquiries from internal and external stakeholders.
• Report to top management on QMS performance and recommend improvements to support strategic goals.
  
  

What You Bring:

• Bachelor’s degree in a relevant field.
• Minimum of 5 years of experience in a GCP or GMP environment.
• Proven knowledge of GCP, GMP, and regulatory guidelines (e.g., ICH, FDA regulations).
• Strong analytical skills with the ability to interpret complex data.
• Excellent verbal and written communication skills.
• Demonstrated experience in project management and change management.
• Proficiency in QMS software and data analysis tools.
• Experience in risk assessment and mitigation strategies.
• Leadership skills with the ability to manage and develop team members.
• Flexibility to work outside standard business hours to support global operations.
  
  

Desirable Qualifications:

• Experience with continuous improvement methodologies (e.g., Lean, Six Sigma).
• Knowledge of ISO 9001 standards.
• Experience in the pharmaceutical, biotechnology, or clinical research industries.
  
  

Why Join Us:

At Signant Health, you’ll have the opportunity to lead a critical function that directly impacts the success of our clinical trials and overall business. If you’re a strategic thinker with a passion for quality and process improvement, we’d love to hear from you.

At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

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