Associate Director, QC Analytical Lifecycle Management

Brief Job Profile Description The Associate Director, QC Analytical Lifecycle Management provides strategic and technical leadership for analytical activities supporting GMP manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness. The role leads the transfer, qualification, validation, verification, implementation, troubleshooting, performance monitoring, continuous improvement, and retirement of analytical methods used for raw materials, in-process samples, release testing, stability testing, and characterization, as applicable. The position partners across Quality Control, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and external testing laboratories to establish robust, phase-appropriate, and compliant analytical capabilities. The role provides scientific direction for complex investigations and technical decisions, influences cross-functional teams and governance, and develops analytical technical operations capability in alignment with patient safety, product quality, compliance, supply, and business needs. 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