Associate Director, Quality Systems Monitoring & Excellence

The Opportunity:

• Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality Management System (QMS).

• Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation.

• Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs).

• Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements.

• Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments.

• Lead the management of critical quality issues and escalations, facilitate timely cross-functional investigations and remediation plans, and ensure effective resolution of compliance risks and regulatory commitments.

• Partner with cross-functional stakeholders to standardize, simplify, and optimize Quality processes while ensuring compliance with global GxP regulations.

• Lead regulatory intelligence activities and translate evolving global regulatory expectations into Quality System enhancements.

• Leverage AI, automation, data analytics, and digital Quality platforms to enhance compliance monitoring, executive reporting, and operational excellence.

• Build and lead a high-performing team while fostering a culture of quality, compliance, inspection readiness, and continuous improvement across the organization.

Required Skills, Experience and Education:

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related scientific discipline; Master's degree preferred.

• 10+ years of progressive Quality Assurance/Quality Systems experience in the biotechnology, pharmaceutical, or medical device industry, including people leadership.

• Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and applicable international quality standards.

• Demonstrated experience leading regulatory inspections, internal audits, Quality Management Reviews (QMRs), and Quality Systems governance.

• Experience with electronic Quality Management Systems (eQMS), such as Veeva Vault or equivalent.

• Excellent leadership, communication, strategic thinking, project management, and stakeholder management skills.

Preferred Skills:

• Experience supporting late-stage clinical development and commercial products.

• Knowledge of AI-enabled quality solutions, digital transformation, data analytics, and executive dashboard development.

• Professional certification such as ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), RAC, or equivalent is preferred.

• Demonstrated ability to lead global, cross-functional initiatives and build high-performing teams in a fast-paced, regulated environment.

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