Associate Director, Quality Assurance & Governance

About This Opportunity

We are representing a confidential biotechnology organization in their search for an Associate Director, Quality Assurance & Governance. This fully remote position offers the opportunity to serve as a strategic quality leader, providing oversight and expertise to support clinical development programs across research, development, and medical functions.

In this role, you will drive quality governance, compliance initiatives, and vendor oversight while partnering with cross-functional teams to ensure adherence to global regulatory standards. You will lead investigations, CAPA processes, and inspection readiness activities that protect study participants and preserve scientific integrity throughout the development lifecycle.

Location: Remote, United States (strong preference for Eastern or Central Time Zones)
Employment Type: Full-time

Responsibilities

• Serve as the quality and compliance representative for assigned clinical studies, programs, and functional areas
• Lead quality oversight activities including Study Risk Assessments, quality health assessments, trend analyses, and risk mitigation planning
• Provide strategic consultation to study teams on GCP requirements, quality standards, and regulatory expectations
• Lead and approve investigations related to deviations, non-conformances, and protocol compliance concerns
• Oversee root cause analysis, CAPA development, implementation, and effectiveness verification
• Drive Vendor Quality Governance activities including vendor qualification, performance oversight, and issue management
• Support internal audits, sponsor audits, investigator site audits, and regulatory inspections
• Lead cross-functional quality improvement initiatives that enhance operational effectiveness and regulatory compliance
• Monitor quality trends and metrics to support informed decision-making and continuous improvement
• Partner with vendor quality representatives to ensure compliance with global regulations and industry standards

What We're Looking For

Required Qualifications:

• Bachelor's degree in a scientific, healthcare, or related discipline
• Minimum 10 years of experience in Clinical Operations, Clinical Quality, Compliance, Quality Assurance, or related pharmaceutical/biotechnology functions
• Extensive knowledge of Good Clinical Practice (GCP) regulations and global clinical development requirements, including FDA regulations and ICH guidelines
• Demonstrated experience supporting quality oversight within clinical development programs
• Experience leading investigations, root cause analyses, and CAPA processes
• Strong understanding of Quality Management Systems, risk management principles, and continuous improvement methodologies
• Experience supporting regulatory inspections and audit activities
• Experience with vendor oversight and Vendor Quality Governance
• Strong analytical, problem-solving, and decision-making skills
• Excellent written, verbal, and stakeholder management skills
• Proven ability to influence without authority and collaborate across multiple functions
• Clinical trial systems and process expertise

Preferred Qualifications:

• Master's degree or advanced degree in Life Sciences, Quality, Regulatory Affairs, Healthcare, or related discipline
• Regulatory inspection management experience
• Experience serving as a Functional Quality Representative for clinical studies
• Experience with Study Risk Assessments and quality governance frameworks
• Experience leading cross-functional quality transformation initiatives
• Prior leadership, coaching, or mentoring experience

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and experience against this role's requirements. If there's a strong match, we'll schedule a detailed screening conversation to understand your background, career goals, and fit for this position.

Once we've aligned on the opportunity, we will submit your profile to our client for consideration. Throughout the interview process, we'll provide guidance and support to help you succeed. Please note that all applications must go through Get A Job.ai—direct contact with the client is not permitted.

Pay

Pay information will be discussed during the screening process with our recruiting team.

Equal Employment Opportunity: Get A Job.ai is committed to fostering an inclusive environment. We consider all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.