Job Description

Job Summary

The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals.

Job Description

Operational Excellence

• Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance.
• Identify and implement best practices, metrics, and tools to drive performance and accountability.
• Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment.
• Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives.

Risk Management

• Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles.
• Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning.
• Monitor and report on key risk indicators and escalate critical risks to senior leadership.

Global Quality System Processes

• Oversee the design, implementation, and maintenance of global quality system processes (e.g., deviation management, CAPA, change control, document management) guided by process excellence principles.
• Ensure harmonization and standardization of quality processes across sites and regions.
• Support quality system enhancements and digital transformation initiatives, ensuring they are informed by robust business process design and governance practices.

Compliance & Governance

• Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards.
• Support internal audits and regulatory inspections, including readiness activities and remediation.
• Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement.

Leadership & Collaboration

• Serve as a technical leader within a matrixed organization.
• Collaborate with Supply Chain, Regulatory Affairs, IT, and other functions to ensure integrated quality operations.
• Align process improvement initiatives with strategic goals and support leadership in prioritizing efforts that deliver the greatest organizational impact.
• Represent Quality Operations in global forums and strategic planning initiatives.

Qualifications

Required

• Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
• 8+ years of experience in pharmaceutical quality operations, with exposure to both small molecule and biologics.
• Strong knowledge of GxP regulations, quality systems, and risk management principles.
• Proven experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
• Excellent communication, leadership, and project management skills.
• Ability to work in a global, matrixed environment and manage multiple priorities.

Preferred

• Experience with global quality systems platforms (e.g., Veeva, TrackWise).
• Familiarity with digital transformation and data analytics in quality operations.
• Prior involvement in regulatory inspections and audit readiness.

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