Job Summary: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 will be expected to work in a highly collaborative, cross functional team environment, provide expert knowledge to risk identification/mitigation, strategy and execution and is expected to make scientific and business critical decisions.
Responsibilities:Analytical Strategy- 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 robust transfer strategies, protocols, acceptance criteria, and success metrics
Commercial Analytical CMC Ownership- 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 / trending, change controls impacting filings, lifecycle improvements and optimization
Stability Program Oversight- 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 to product quality
- Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates
Laboratory Operations- 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
External Laboratories & CDMO Oversight- 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
Investigations & Problem Solving- 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
Compliance & Inspection Readiness- 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
People Leadership- Lead, develop, and scale QC laboratory teams (scientists, analysts, managers)
- Build 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.
QUALIFICATIONS- 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, 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
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
