Director, Quality Analytical Technical Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Quality Analytical Technical Lead, Small Molecule based in United States.

• Serve as the global point of contact and accountable owner for analytical matters associated with assigned commercial small-molecule products across major markets, including the US, EU, China, Australia, and Canada, while supporting expansion into additional regions.
• Provide technical governance and leadership across analytical activities for drug substance, drug product, and applicable critical raw materials and reagents.
• Translate global product strategies into clear analytical expectations, priorities, and deliverables for internal quality control sites, external laboratories, contract manufacturing organizations, and other technical partners.
• Lead and approve strategies for analytical investigations, including OOS, OOT, OOE, atypical results, invalidations, root-cause assessments, CAPA, and method optimization.
• Drive analytical change-control strategies and execution plans covering method updates, revalidation or verification, reference-standard changes, and instrument or software upgrades.
• Manage escalation of supply-critical analytical issues and align resolution strategies across Quality, Regulatory, Supply Chain, and other relevant functions.
• Own global processes and technical knowledge related to commercial analytical method lifecycle management, including validation and verification strategies, transfers, periodic reviews, trending, and robustness improvements.
• Govern global release and stability specifications, supporting harmonization, lifecycle updates, and scientifically justified changes.
• Lead stability-program strategy, including protocols, regulatory commitments, pull schedules, trend evaluation, and annual review narratives.
• Provide governance for retest periods and shelf life, including extensions, commitments, labeling considerations, and country-specific requirements.
• Ensure development-to-commercial handover of submission-ready analytical documentation, including control strategies, method histories, validation packages, specification rationales, and stability narratives.
• Maintain alignment between analytical control strategies and product risk profiles, including critical quality attributes, critical process parameters, and small-molecule impurity controls.
• Provide analytical subject matter expertise for global regulatory submissions, including Module 3 sections, stability commitments, post-approval variations, supplements, comparability narratives, and analytical bridging.
• Partner with Regulatory CMC teams on health-authority interactions and responses concerning analytical controls, stability trends, and specification justification.
• Provide governance and oversight for external quality-control networks, including expectations, performance metrics, investigation quality, and escalation pathways.
• Support audits and regulatory inspections as the product analytical SME and ensure assigned products and analytical systems remain inspection-ready.
• Influence laboratory capacity planning and capability investments through risk-based technical assessments.

• Bachelor’s degree with 10+ years of biopharmaceutical experience, including significant responsibility for commercial product lifecycle management; a Master’s degree with 7+ years or a doctoral degree with 5+ years of relevant experience is preferred.
• Demonstrated leadership experience in GMP Quality Control and/or analytical sciences, particularly supporting commercial small-molecule products.
• Strong technical expertise in small-molecule analytical methods, including HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, and genotoxic impurities, as applicable.
• Strong working knowledge of analytical method validation and verification, stability trending and statistical evaluation, specification lifecycle management, and data integrity.
• Experience making scientifically sound, risk-based decisions across analytical investigations, method changes, specifications, stability programs, and lifecycle activities.
• Understanding of global GMP, pharmacopeial, and regulatory expectations and the ability to produce documentation and narratives that withstand regulatory inspection.
• Experience supporting regulatory submissions, post-approval changes, analytical comparability, and health-authority interactions is highly valuable.
• Strong ability to lead through influence within a matrix organization, with excellent stakeholder management, negotiation, and cross-functional collaboration skills.
• Excellent technical writing and communication capabilities, with the ability to explain complex analytical and quality topics clearly.