Director, Quality Control

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
• 1015 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.

As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

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.

Required Experience:

Director