New · posted Oct 15
Aquestive Therapeutics · Pharmaceuticals
Director, Quality Assurance
- Portage, IN
- On-site
- Full-time
- Director
Open until filled
The role
The Director of Quality Assurance is a leadership role, responsible for all aspects of the Quality Systems, Clinical Quality and Manufacturing Quality for Aquestive. The Director of Quality Assurance will work with their direct managerial reports, as well as Executive Leadership, to ensure a continued state of compliance while promoting a strong quality culture across the organization for all products, spanning early phase development to commercialization.
This position will be expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to risk identification/mitigation, strategy and execution.
What you need
- Minimum of Bachelor’s degree required. Advanced degree in chemistry, engineering, biochemistry, or related science field desirable.
- Minimum 7+ years of related work experience working in a regulated GxP industry in pharmaceutical manufacturing operation setting or service oriented laboratory.
- Demonstrated ability to direct a function, oversee projects and teams. Minimum of 2 years overseeing direct reports.
- Minimum of 2+ years working in a managerial role with direct reports.
- 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.
As part of Aquestive’s 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.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
What you'll do
- Oversee all aspects of Quality Systems, Clinical Quality and Manufacturing Quality to assure compliance with FDA, EU, ANVISA, TGA and other international GMP requirements for all products manufactured at Aquestive (e.g., 21 CFR Part 210 + 211, EU GMP Volume 4 Part 1).
- Provide strategic direction and leadership to ensure effectiveness of Quality Systems (e.g., CAPA, Change Management, Event Management, Supplier Quality, Internal Audit, Document Management, Risk Management, Record Review and Product Disposition, Training, Field Alert/Recall, etc.)
- Lead and ensure execution of quality strategy for all development and manufacturing activities associated with all products manufactured by Aquestive, including external GMP contract manufacture operations or laboratories for drug substance and drug product.
- Primary contact for all inspection interactions with all domestic and ex-US regulatory authorities.
- Provide direction for escalated quality issues as they arise, determining the need for, and structuring communication for, further escalation to the Executive team and/or external parties.
- Lead strategic quality to quality relationships with business partners, suppliers, external CMOs and third-party testing laboratories.
- Ensure the company is upholding to Quality/Technical Agreements with business partners and suppliers.
- Provides input to all functions to ensure clinical trial activities are conducted in compliance with GCP regulations and internal requirements.
- Actively participate in the Site Leadership Team to drive continuous improvement activities and initiatives throughout Aquestive.
- Analyze, report and present metrics where applicable to show health of system(s).
- Lead GxP inspection strategies across all auditable areas to ensure the company is in an audit-ready status at all times.
- Manage overall coaching, training, development and succession planning for the function.
- Set, manage and monitor budget for Quality Assurance, in conjunction with finance.
Where you'll work
Portage, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Portage, INEqual opportunity, accessibility and legal noticesAquestive Therapeutics's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $186,500 | $209,250 | $231,375 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Aquestive Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- GMP and compliance8
- Quality systems and risk6
- Documentation and SOPs5
- Lab testing and methods4
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Aquestive Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Senior & Principal2 50%
- Director1 25%
- Associate & Specialist1 25%
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Director, Quality Assurance at Aquestive Therapeutics
Open until filled.