Director of Quality

About the role

The Director of Quality Assurance serves as an Operating Unit-level Quality Transformation leader for the Drug Delivery Devices portfolio. Reporting to the Senior Director of Quality, this role is accountable for driving cross-site harmonization and operational excellence across three manufacturing sites, with explicit governance responsibility for change control and document management processes.

Responsibilities

• Accountable for Operating Unit-level governance of change control and document management processes across three manufacturing sites.
• Define, standardize, and institutionalize harmonized quality processes that balance regulatory compliance, operational efficiency, and customer expectations.
• Establish clear process ownership models and transition stabilized processes to designated site or enterprise process owners.
• Ensure alignment of site-level execution with Operating Unit quality standards and performance objectives.
• Identify and eliminate process complexity, redundancy, and inefficiencies across sites.
• Lead cross-site process improvement initiatives focused on measurable cycle time reduction, workflow simplification, and improved transparency.
• Drive achievement of targeted reductions in onboarding, change control, and document management cycle times.
• Apply structured continuous improvement methodologies (e.g., Lean, Six Sigma, value stream mapping) to redesign critical quality workflows.
• Partner with Site Quality leaders and Operations to deploy standardized solutions while maintaining operational continuity.
• Influence and support enterprise QMS harmonization initiatives by defining process requirements and governance expectations.
• Own Operating Unit quality KPI governance, ensuring metrics are meaningful, predictive, and aligned with strategic priorities.
• Transition manual reporting processes (Excel, PowerPoint-based) to scalable, automated reporting solutions.
• Define standard metric definitions and reporting cadences across sites.
• Provide executive-level dashboards and performance insights to Operating Unit leadership.
• Identify leading indicators of quality risk and performance degradation.
• Serve as the primary quality interface for key pharmaceutical customers within the Operating Unit.
• Lead quality discussions during Quarterly Business Reviews and executive customer meetings.
• Provide data-driven performance updates, proactive risk communication, and continuous improvement roadmaps.
• Strengthen customer confidence through transparency, consistency, and harmonized quality execution.
• Partner with Commercial and Operations to address systemic quality concerns impacting customer experience.

Requirements

• Bachelor's Degree in Science, Engineering, or related field required.
• Minimum 10 years of progressive Quality experience in FDA-regulated medical device or combination product environments.
• Demonstrated experience leading cross-site or multi-site quality initiatives.
• Experience governing or improving core Quality System processes (e.g., change control, document management, lifecycle processes).
• Experience operating effectively in a matrix environment without direct authority.
• Experience interfacing with external customers on quality-related matters.

Qualifications

• Deep knowledge of core Quality System processes within FDA-regulated medical device or combination product environments, including change control, document management, CAPA, and risk management principles.
• Strong understanding of applicable global medical device regulations and standards (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR), with the ability to translate regulatory expectations into practical and scalable quality processes.
• Practical experience applying Lean, Six Sigma, or other continuous improvement methodologies to reduce cycle times and improve process transparency.
• Strong analytical capability, including development and governance of quality KPIs and performance dashboards.
• Experience modernizing reporting structures and supporting automation of quality data tracking and visualization tools.
• Ability to operate effectively in a matrixed and geographically diverse organization, influencing without direct authority.
• Executive-level verbal and written communication skills, with the ability to present complex quality information clearly to senior leadership and external customers.
• High degree of ownership, accountability, and strategic thinking.
• Strong organizational and follow-through skills with the ability to manage multiple cross-site initiatives concurrently.

Skills

• Strong analytical capability, including development and governance of quality KPIs and performance dashboards.
• Practical experience applying Lean, Six Sigma, or other continuous improvement methodologies to reduce cycle times and improve process transparency.
• Ability to operate effectively in a matrixed and geographically diverse organization, influencing without direct authority.
• Executive-level verbal and written communication skills, with the ability to present complex quality information clearly to senior leadership and external customers.
• Strong organizational and follow-through skills with the ability to manage multiple cross-site initiatives concurrently.

Benefits

Not specified.

Pay

Not specified.

Schedule

Hybrid position requiring the team member to be onsite a minimum of 3 days per week.