Associate Director, QC Analytical Lifecycle Management

Typical Accountabilities

• Provide strategic, scientific, and operational leadership for GMP analytical technical operations supporting manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness.

• Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement in accordance with approved procedures and regulatory expectations.

• Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support.

• Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments.

• Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments, within assigned authority and applicable procedures.

• Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners.

• Ensure analytical methods and associated control strategies are scientifically sound, fit for intended use, appropriately validated, and compliant with GMP, data integrity principles, relevant pharmacopeias, approved procedures, and applicable regulatory commitments.

• Lead assessments of method performance and laboratory trends, identify emerging risks, and implement sustainable improvements that strengthen robustness, efficiency, right-first-time execution, and inspection readiness.

• Author, review, and approve protocols, reports, procedures, technical assessments, specifications, validation documentation, regulatory-supporting content, and other GMP records within assigned authority.

• Support regulatory submissions, health authority questions and inspections, internal and external quality audits, and regulatory commitments by providing clear technical rationale, documentation, and subject matter expertise.

• Develop and manage program plans, priorities, resources, timelines, metrics, and governance to deliver analytical activities in alignment with manufacturing schedules and business objectives.

• Provide analytical technical expertise for raw-material testing, extended characterization, and external testing laboratories when required by product, program, or laboratory needs.

• Provide technical governance and performance oversight for external laboratories, including alignment on technical expectations, issue escalation, and delivery requirements, in partnership with accountable Quality and Supply functions.

• Influence and align cross-functional teams and technical stakeholders; lead, coach, and develop analytical technical operations professionals as organizational scope and staffing require.

• Maintain awareness of current regulatory and industry standards, including relevant pharmacopeial requirements, FDA and other health authority guidance, ICH guidance, and industry best practices.

• Make timely, risk-based decisions in a matrix environment, including when information is incomplete or timelines are constrained, while maintaining patient safety, product quality, and compliance as primary priorities.

• Perform other duties, as appropriate.