Director, Quality Control

The Director, Quality Control serves as the commercial CMC analytical owner, accountable for ensuring analytical methods, stability programs, and laboratory operations collectively enable compliant product supply and lifecycle management. This position requires a highly collaborative, cross‑functional approach, expert knowledge in risk identification and mitigation, and the ability to make science‑driven, business‑critical decisions.

• Direct QC support for CMC development, regulatory submissions, and product lifecycle management across all products.
• Ensure alignment of QC activities with regulatory submissions (IND, NDA, MAA) and post‑approval commitments.
• Establish transfer strategies, protocols, acceptance criteria, and success metrics.

• Accountable for CMC readiness and sustainment post‑approval.
• Ensure CMC deliverables are complete, scientifically sound, and inspection ready.
• Own post‑approval analytical CMC lifecycle, including annual product reviews, change controls, and lifecycle improvements.

• Own stability as a CMC deliverable linked to shelf life, regulatory and partner commitments, and supply.
• Provide scientific assessment of stability trends, OOT results, and potential impact on product quality.
• Partner with Quality, AR&D, and Regulatory teams to support IND/NDA/MAA submissions and annual updates.

• Direct day‑to‑day QC lab operations (release, stability, in‑process, raw materials).
• Ensure timely and reliable testing to support manufacturing and release schedules.
• Maintain laboratory compliance with cGMP, data integrity, and ALCOA+ principles.
• Oversee scheduling, capacity planning, and resource management.

• Provide oversight of contract laboratories and CDMOs performing analytical testing.
• Review and approve analytical data, deviations, and investigations from external partners.
• Support Quality Agreements and clearly defined analytical responsibilities.

• Lead complex OOS, OOT, and deviation investigations related to analytical results and product performance.
• Drive root cause analysis and scientifically sound CAPAs.
• Partner cross‑functionally to resolve issues.

• Ensure QC systems meet global regulatory expectations (FDA, EMA, ICH).
• Lead inspection readiness activities and serve as QC lead during inspections.
• Ensure data integrity, documentation practices, and audit responses meet expectations.
• Lead, develop, and scale QC laboratory teams (scientists, analysts, managers).
• Build a strong technical and compliance culture with clear accountability.
• Drive capability building in analytical science, problem‑solving, and inspection readiness.
• Participate in all third‑party and customer audits and inspections, and corrective action response.

• Lead, develop, and scale QC laboratory teams (scientists, analysts, managers).
• Build a strong technical and compliance culture with clear accountability.
• Drive capability building in analytical science, problem‑solving, and inspection readiness.
• Participate in all third‑party and customer audits and inspections, and corrective action response.

• PhD, MS, or BS in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 10–15+ years in pharmaceutical/biotech Quality Control or Analytical Sciences.
• Significant experience in CMC development and commercialization, analytical method development, validation, and transfer, and managing QC labs in a cGMP environment.
• Strong understanding of regulatory expectations (FDA, EMA, ICH).
• Experience overseeing CDMOs and contract laboratories.
• Proven leadership in inspections and complex investigations.
• Strong business acumen surrounding pharmaceutical manufacturing.
• Some travel is required.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Equal Opportunity Employer.