Director, Quality Analytical Technical Lead, Small Molecule

• The Analytical Technical Lead (ATL) is the single global point of contact and accountable owner for analytical lifecycle management of assigned commercial products across major markets (US, EU, China, Australia, Canada) and supports Rest of World (RoW) expansion and post-approval maintenance.
• At Director level, this role is responsible for making risk-based, inspection-defensible decisions on methods, specifications, stability, and analytical investigations across a distributed internal/external QC network for small molecule products.
• This leader ensures the analytical control strategy remains robust over the product lifecycle, drives harmonization, and enables reliable supply while meeting GMP, pharmacopeial, and regulatory expectations.
• The Analytical Technical Lead (ATL) may own relevant global business processes, ensure compliance and efficiency., A. Global Analytical Point of Contact (PoC) for Approved Commercial Products
• Act as the global PoC for all analytical-related matters for assigned products, to ensure analytical readiness.
• Provide governance and technical leadership for analytical topics spanning drug substance (DS), drug product (DP), and critical raw materials/reagents as applicable.
• Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.

B. Analytical Lifecycle Management: Changes, Deviations, and Investigations

• Lead and approve strategy for analytical investigations and performance issues (OOS/OOT/OOE, atypical results, invalidations), ensuring scientifically sound root cause analysis and effective CAPA, including method optimization.
• Drive analytical change control impact assessments and execution plans, including method updates, revalidation/verification, reference standard changes, and instrument/software upgrades.
• Own escalation management for supply-critical analytical events; align actions with Quality, Regulatory, and Supply Chain.

C. Global Business Process & Knowledge Owner: Methods, Specifications, Stability, Retest/Shelf Life

• Serve as global business process and knowledge owner for:
• Commercial analytical method lifecycle (validation/verification strategy, transfers, periodic review, trending, method robustness improvements)
• Global specifications governance (release and stability), including harmonization and lifecycle updates
• Stability program ownership (protocol strategy, commitments, pull schedules, trending, annual review narratives)
• Retest period/shelf-life governance (extensions, commitments, labeling impacts, country-specific constraints)
• Take over “submission-ready” documentation sources from development: analytical control strategy, method history, validation packages, specification rationale, and stability trend narratives.
• Ensure defensible alignment between analytical control strategy and product risk profile (CQAs/CPPs), including small-molecule impurity control.

D. Regulatory Support: RoW Filings and Post-Approval Variations

• Provide analytical SME leadership for global regulatory submissions relevant to QC:
• RoW filings (Module 3 analytical sections, stability commitments, method/spec alignment)
• Post-approval changes (variations, supplements), including comparability narratives and analytical bridging
• Partner with Regulatory CMC on health authority interactions and responses related to analytical controls, stability trends, and specification justification.

E. Partner and Network Oversight (Internal QC and External Labs/CMOs)

• Provide governance for external QC networks: align expectations, metrics, investigation quality, and issue escalation pathways (with ESQ as needed).
• Contribute to audits/inspections as product analytical SME; ensure inspection readiness for assigned products and analytical systems.
• Influence lab capacity planning and capability upgrades with a risk-based view.

• Bachelor’s degree and 10+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience required
• Master’s degree and 7+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience preferred
• Doctoral Degree and 5+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience desired

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)., * Demonstrated leadership in GMP QC and/or analytical sciences for:
• Small molecule methods (HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, genotox impurities as applicable)
• Strong working knowledge of method validation/verification, stability trends and statistical evaluation, specification lifecycle management, and data integrity.

Leadership Competencies

• Ability to lead through influence in a matrix organization; strong stakeholder management and negotiation skills.
• Strong technical writing and ability to deliver inspection-defensible narratives.
• Program and risk management mindset; ability to prioritize in supply-constrained environments.