The Associate Vice President (AVP), Quality Assurance serves as the organization's highest-ranking Quality leader, reporting directly to the Chief Executive Officer. This executive role provides strategic leadership and operational oversight for SCRI's Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, industry standards, and organizational policies.
The AVP is responsible for driving a culture of quality and continuous improvement across the organization, maintaining a state of ongoing inspection readiness, and advancing quality initiatives that support operational excellence and organizational growth. As a key member of the leadership team, this individual partners closely with stakeholders across the enterprise to strengthen quality processes, mitigate risk, and ensure the highest standards of research integrity, participant safety, and regulatory compliance.
This is a remote position based in the US; relocation assistance and visa sponsorship are not available.
Key Responsibilities for success include:
Provide senior Quality leadership and operational direction to support consistent execution of the Quality function across SCRI in alignment with organizational objectives.Lead, develop, and mentor a high-performing Quality Assurance team, fostering a culture of accountability, collaboration, continuous learning, and operational excellence.Establish clear goals, performance expectations, and development plans for Quality staff, ensuring the team has the capabilities and resources needed to support organizational growth and evolving regulatory requirements.Build and sustain strong partnerships across departments, serving as a strategic advisor to executive leadership and key stakeholders on quality, compliance, and risk management matters.Maintain, optimize, and continuously improve the established Quality Management System (QMS) to ensure it remains effective, risk-based, scalable, and responsive to business and regulatory requirements.Ensure regulatory compliance and sustained inspection readiness through oversight of policies, procedures, training, documentation practices, and quality oversight activities.Oversee audits, inspections, CAPA, deviations, investigations, and quality metrics, using trend analysis and risk evaluation to support timely and effective resolution of quality issues.Advance continuous improvement efforts that strengthen quality processes, systems, and performance measures in alignment with regulatory expectations and business priorities.Drive organizational quality initiatives by promoting best practices, change management, and cross-functional engagement to enhance quality culture and enterprise-wide compliance.Manage departmental priorities, budgets, and resource allocation to ensure efficient and effective delivery of Quality Assurance services and strategic objectives.
Success in this role is measured by the ability to:
Maintain a strong culture of quality and compliance across the organization.Ensure ongoing inspection readiness and successful regulatory audits and inspections.Drive continuous improvement of the Quality Management System (QMS) and related processes.Achieve timely and effective resolution of audits, CAPAs, investigations, deviations, and other quality issues.Develop and retain a high-performing Quality team through effective leadership, coaching, and talent development.Deliver meaningful improvements in quality metrics, operational efficiency, and risk management.Build strong partnerships with business leaders and stakeholders to support organizational objectives.Ensure quality initiatives align with business goals while meeting applicable regulatory and industry requirements.
This role is successful when SCRI maintains a compliant, inspection-ready environment, quality risks are proactively managed, and the Quality function is viewed as a trusted strategic partner across the organization.
Qualifications for success include:
Progressive Quality Assurance, Quality Management, or compliance leadership experience in regulated healthcare, clinical research, life sciences, or similar industries.Experience managing Quality Management Systems, including audits, inspections, CAPA, deviations, change control, training, and quality metrics.Proven success leading teams, partnering across functions, and driving quality, operational improvements, and business results.Extensive knowledge of FDA guidelines, GCP, applicable regulations, Quality and Clinical IT Systems and experienceKnowledge of medical and clinical research terminologyThorough understanding of investigative site research requirements, quality metrics, and performance measures7+ years' experience interpreting and applying regulatory requirements, translate them to operational practice, and provide practical guidance to leadership and cross-functional business partners.Highly effective ability to engage with senior leaders, regulators, auditors, and internal stakeholders on quality and compliance matters.Bachelor's Degree required, Master's Degree preferred
RAPS - Regulatory Affairs Certification highly preferred
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As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
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