Director, Quality Assurance

Aquestive Therapeutics; Portage (IN); On-site; USD 100,000 - 140,000; Full time

Job summary

Aquestive Therapeutics in Portage, Indiana is seeking a Director of Quality Assurance. This leadership position is responsible for overseeing all Quality Systems, ensuring compliance with regulations including FDA and GMP. The role requires collaboration across teams and effective management of quality strategies throughout the product lifecycle.

The ideal candidate will have a minimum of 7 years of experience in a regulated GxP industry, strong leadership skills, and a Bachelor’s degree or higher in a relevant field. Responsibilities include managing quality at all manufacturing stages and interacting with regulatory authorities.

Qualifications

• 7+ years of experience in a regulated GxP industry.
• 2+ years of managerial experience overseeing direct reports.
• Strong skills in critical reasoning and decision making.

Responsibilities

• Oversee all aspects of Quality Systems for compliance.
• Lead and execute quality strategy for all manufacturing activities.
• Provide strategic direction for quality relationships with partners.

Skills

Problem solving

Strategic thinking

Project management

Interpersonal skills

Communication skills

Organizational skills

Education

Bachelor’s degree

Advanced degree in chemistry or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Visio

Job description

Job Summary:

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.

Responsibilities:

• 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.

Qualifications:

• 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.

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 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.

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.