Senior Director, Quality Control

Key Responsibilities

Quality Control Strategy and Laboratory Operations

• Set the Quality Control strategy and operating priorities in alignment with company, site, product, and Quality objectives.
• Provide oversight of laboratory operations and testing performed in support of raw materials, in-process samples, final product, stability programs, environmental monitoring, and other required quality activities.
• Ensure testing is planned, performed, reviewed, and reported accurately and within established timelines to support manufacturing and product disposition.
• Establish laboratory capacity and resource plans based on production schedules, testing demand, business priorities, and future growth.
• Maintain clear governance for work prioritization, issue escalation, and coordination across Quality Control teams and sites.

Compliance and Inspection Readiness

• Ensure Quality Control activities comply with applicable current Good Manufacturing Practice requirements, company procedures, regulatory commitments, and industry standards.
• Maintain inspection readiness across Quality Control laboratories, systems, records, and personnel.
• Represent Quality Control during regulatory inspections, customer or partner audits, and internal audits, and ensure timely, complete responses to requests and observations.
• Promote data integrity and complete, accurate, and contemporaneous documentation throughout laboratory operations.
• Review relevant regulatory submissions and post-approval changes for technical accuracy and consistency with Quality Control capabilities and commitments.

Testing Governance and Product Support

• Establish and maintain effective oversight of internal and external testing, including schedules, sample flow, results, exceptions, and release dependencies.
• Partner with Quality Assurance, Manufacturing and other functions to support timely product review, disposition and patient delivery while maintaining quality and compliance requirements.
• Ensure appropriate technical review and approval of laboratory methods, specifications, protocols, reports, and controlled procedures.
• Provide Quality Control leadership for new products, technology transfers, process changes, method transfers, validation activities, and laboratory readiness.
• Ensure qualified vendors and contract laboratories are appropriately governed and that performance, risks, and issues are routinely reviewed and escalated.

Investigations and Quality Systems

• Provide oversight of laboratory investigations, deviations, out-of-specification and out-of-trend results, corrective and preventive actions, change controls, and related risk assessments.
• Ensure investigations are scientifically sound, completed on time, and address root cause, product impact, recurrence risk, and effective corrective actions.
• Identify and escalate significant quality, compliance, testing, capacity, and supply risks with clear recommendations and recovery plans.
• Use investigation trends and performance data to identify recurring issues and strengthen laboratory controls and systems.

People and Financial Leadership

• Select, develop, and retain qualified leaders and staff with the technical knowledge and judgment required to perform Quality Control responsibilities.
• Set clear objectives, assign accountability, and provide ongoing coaching, feedback, recognition, and performance management.
• Ensure personnel are trained and qualified for assigned responsibilities and maintain an organization structure that supports effective oversight and succession planning.
• Develop and manage the Quality Control budget, headcount plan, operating expenses, capital needs, and external testing spend.
• Promote a culture of patient focus, quality, ethical conduct, collaboration, accountability, and timely escalation.

Performance Management and Continuous Improvement

• Establish and report performance measures for testing cycle time, schedule adherence, right-first-time performance, investigation timeliness, laboratory capacity, compliance, and external laboratory performance.
• Use performance data and tiered management routines to identify constraints, set priorities, and drive timely decisions and actions.
• Sponsor improvements to laboratory processes, systems, workflows, and electronic tools that increase reliability, efficiency, visibility, and compliance.
• Lead or support cross-functional initiatives that improve manufacturing support, testing readiness, product release, and organizational performance.