Director, Quality Assurance
Company: Aquestive Therapeutics
Posted on: January 26, 2023
The Director of Quality Assurance is a leadership role, responsible
for all aspects of the Quality Systems, Manufacturing Quality and
Quality Control Laboratory for Aquestive. The Director of Quality
Assurance will work with their direct managerial reports, as well
as Executive Leadership, for ensuring a continued state of
compliance while promoting a strong quality culture across the
organization for all products, spanning early phase development to
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.
- Oversee all aspects of Quality Systems, Manufacturing Quality
and Quality Control Laboratory 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.)
- Provide strategic direction and leadership of all aspects of
the Quality Control Laboratory in support of stability, raw
materials, in-process, drug substance, and finished
- Provide expert technical support for method development
transfers, qualification, validation and laboratory out of trend
(OOT) and out of specification (OOS) investigations.
- 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
- 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
- Lead strategic quality to quality relationships with business
partners, suppliers, external CMOs and third-party testing
- Ensure company is upholding to Quality/Technical Agreements
with business partners and suppliers.
- Actively participate on the Site Leadership Team to drive
continuous improvement activities and initiatives throughout
- Lead inspection strategies for cGMP sites, ensuring
audit-readiness at all times.
- Manage overall coaching, training, development and succession
planning for the function.
- Minimum of Bachelor's degree required. Advanced degree in
chemistry, engineering, biochemistry, or related science field
- 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
- Strong skillset in problem solving, strategic thinking,
critical reasoning and decision making.
- Strong interpersonal skills and verbal/written communication
- 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
- Strong business acumen surrounding pharmaceutical
- Some travel 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 as an exhaustive list of all
responsibilities, duties, and skills required. Aquestive reserves
the right to make changes to the job description whenever
As part of Aquestive's employment process, final candidate will be
required to complete a drug test and background check prior to
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
Keywords: Aquestive Therapeutics, Gary , Director, Quality Assurance, Executive , Portage, Indiana
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