Aquestive Therapeutics · 11 hours ago
Sr. Manager, Quality Control
Portage, IN
Full-time
Onsite
Senior Level
7+ years expAquestive Therapeutics is a pharmaceutical company focused on improving the lives of patients. The Senior Manager Quality Control is responsible for overseeing all aspects of the Quality Control Laboratory, ensuring product quality, compliance with regulatory requirements, and leading a collaborative team environment.
Pharmaceutical
Responsibilities
Lead, develop and manage the Quality Control function including the Finished/In-Process Product Test Program, Raw Material Test Program, Stability Program, Environmental Monitoring Program and Analytical Method Transfer Program
Provide expertise, direction and resources for operational issues/investigations, process improvement activities, new raw material testing, and new product specification development
Manage laboratory operations including budgeting, procurement, instrumentation and equipment
Oversee relationship for all Third-Party Laboratories, including Quality Technical Agreements, Service Agreements/contracts and issue escalation, ensuring compliance with business and regulatory standards
Manage the execution of Stability Program, ensuring the performance of data analysis and trending throughout various timepoints to key stakeholders
Manage the execution of the Environmental Monitoring Program for both facilities, including analyzing and trending of data
Lead life cycle management of all analytical methods for commercial products, trending, identifying and implementing change when necessary through metrics and analytics
Partner with Research & Development on analytical method development, validation and transfer across all methods
Evaluate new procedures and/or software and/or equipment for use within the laboratory and develop a strategy for laboratory operations
Canvas global industry improvements, changes and forums, taking information back internally and applying to Aquestive
Conduct performance appraisals; provides feedback; and assists in setting goals and objectives
Participate in all third party and customer audits and inspections, and corrective action responses
Qualification
Required
Minimum of Bachelor's degree required
Minimum 7+ years of related work experience working in a Quality Control for a pharmaceutical drug product manufacturing operation
Minimum of 3+ years experience in managing direct reports in a Quality Control Lab
Deep understanding of cGMP, ICH guidelines, USP requirements and regulatory expectations for drug manufacturing and QC testing
Demonstrated ability to lead a group, oversee projects and teams, and work cross-functionally to deliver results
Expertise in the use of HPLC instruments and data collection software
Strong skillset in problem solving, strategic thinking, critical reasoning and decision making
Strong interpersonal skills and verbal/written communication skills
Excellent computer skills required (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio)
Strong project management skills, strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and on budget
Strong business acumen surrounding pharmaceutical manufacturing
Some travel required
Preferred
Advanced degree in chemistry, engineering, biochemistry, or related science fields are desirable
Experience with the implementation and use of a Laboratory Information Management System (LIMS) is desirable
Company
Aquestive Therapeutics
Aquestive is a specialty pharmaceutical company that advances and commercializes medicines to solve critical healthcare problems.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$453.06MKey Investors
RTW InvestmentsLincoln Park Capital FundMadryn Asset Management
2025-08-14Post Ipo Equity· $85M
2024-03-19Post Ipo Equity· $75M
2023-11-02Post Ipo Debt· $45M
Leadership Team
Daniel Barber
Chief Executive Officer
Peter Boyd
Chief People Officer
Recent News
BioWorld Financial Watch
2026-02-04
2026-02-03
Company data provided by crunchbase