Director, Quality Analytical Technical Lead, Small Molecule

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.

This is a senior technical leadership opportunity focused on the global analytical lifecycle of commercial small-molecule products.
You will serve as the accountable global technical lead for analytical strategy across major international markets and support broader post-approval expansion.
The role combines deep GMP analytical expertise with quality, regulatory, supply, and lifecycle management responsibilities.
You will make risk-based, inspection-defensible decisions covering analytical methods, specifications, stability, investigations, and changes.
Working across internal quality teams, external laboratories, manufacturing partners, and regulatory stakeholders, you will drive consistency and technical excellence.
The position is ideal for a strategic scientific leader who can influence across a complex matrix while maintaining a strong focus on product quality and reliable supply.
You will also contribute to global process ownership, regulatory submissions, inspection readiness, and continuous improvement of analytical systems.

Accountabilities

• 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.

Requirements

• 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 to scientific, quality, regulatory, and business stakeholders.
• Strong program and risk-management mindset, including the ability to prioritize effectively in supply-constrained or time-sensitive environments.
• Strong analytical thinking, problem-solving, initiative, adaptability, and results orientation.
• Comfortable working collaboratively across geographically distributed internal teams and external partners.
• Strong proficiency with standard business software, including Microsoft Office applications such as Outlook, Word, Excel, and PowerPoint.
• Willingness and ability to travel internationally or domestically as required, with travel expected to be up to 20% .

Benefits

• Annual base salary range of $168,000–$228,000 , with actual compensation determined by experience, skills, qualifications, education, certifications, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Opportunity to receive discretionary equity awards and participate voluntarily in an Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance .
• 401(k) retirement plan.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
• Life insurance coverage.
• Paid time off and wellness benefits.
• Remote-based position within the United States.
• Opportunity to work on global commercial product portfolios and collaborate with multidisciplinary teams across international markets.
• Exposure to complex analytical lifecycle, quality, regulatory, and supply challenges within a rapidly growing biopharmaceutical environment.
• Inclusive workplace focused on collaboration, continuous learning, scientific excellence, and patient impact.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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