Associate Director, Quality Assurance & Governance

About This Opportunity

We are representing a confidential biopharmaceutical organization in their search for an Associate Director, Quality Assurance & Governance. This is a remote position based in the United States, with a strong preference for candidates located in the Eastern or Central Time Zones.

This role serves as a strategic quality leader, providing oversight, guidance, and expertise to support the effectiveness of the Quality Management System (QMS) across research, development, and medical operations. You will drive a culture of quality and compliance through leadership of vendor quality governance activities, functional quality representation for clinical studies, quality risk management, investigations, CAPA oversight, inspection readiness, and continuous improvement initiatives.

Responsibilities

• Serve as the Clinical Quality & Compliance representative for assigned studies, programs, and functional areas, providing expert guidance on quality and compliance matters
• Support the development, maintenance, and continuous improvement of the Quality Management System by driving quality governance, process enhancement, and compliance initiatives
• Lead quality oversight activities for clinical studies and programs, including Study Risk Assessments (SRAs), quality health assessments, trend analyses, and risk mitigation planning
• Provide strategic leadership and consultation to study teams and functional stakeholders on GCP requirements, quality standards, and regulatory expectations
• Lead and approve investigations related to deviations, non-conformances, protocol compliance concerns, and other GCP-regulated quality events
• Oversee root cause analysis, CAPA development, implementation, and effectiveness verification to ensure sustainable issue resolution and continuous improvement
• Drive Vendor Quality Governance activities, including vendor qualification, performance oversight, quality risk assessments, issue management, and remediation activities
• Partner with vendor quality representatives and internal stakeholders to ensure vendor compliance with global regulations, industry standards, and contractual quality obligations
• Support internal audits, sponsor audits, investigator site audits, and regulatory inspections through preparation, risk assessment, response management, and inspection readiness activities
• Lead cross-functional quality improvement initiatives that enhance operational effectiveness, inspection readiness, and regulatory compliance
• Monitor quality trends and metrics, providing insights and recommendations to support informed decision-making and continuous quality improvement

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, ICH guidelines, and applicable international regulations
• Demonstrated experience supporting quality oversight within clinical development programs and studies
• Experience leading investigations, root cause analyses, CAPA development, implementation, and effectiveness verification
• Strong understanding of Quality Management Systems (QMS), risk management principles, quality metrics, and continuous improvement methodologies
• Experience supporting regulatory inspections, sponsor audits, and internal audit activities
• Experience with vendor oversight and Vendor Quality Governance activities
• Strong analytical, problem-solving, organizational, and decision-making skills
• Excellent written, verbal, facilitation, and stakeholder management skills
• Proven ability to influence without authority and effectively collaborate across multiple functions and organizational levels
• Ability to independently manage competing priorities while maintaining a high level of quality and attention to detail
• Clinical trial systems and process expertise required

Preferred Qualifications:

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

How We Work With You

Our talent team at Get A Job.ai partners with leading organizations to connect exceptional candidates with outstanding opportunities. When you apply through our platform, a dedicated recruiter will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration and guide you through each stage of the hiring process.

Please apply exclusively through Get A Job.ai. Do not attempt to contact the hiring organization directly, as all applications must be submitted through our recruiting process.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Employment Opportunity: Get A Job.ai is committed to fostering an inclusive environment. We welcome applications from candidates of all backgrounds and work to ensure fair consideration throughout our recruitment process.