Director, Quality Assurance

Regulatory Toolkit; Portage (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Aquestive seeks a Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality, ensuring FDA and international GMP compliance for all products from development to commercialization.

You will partner with executive leadership and cross-functional teams to drive risk management, CAPA, audits, and continuous improvement, while maintaining audit readiness and a strong quality culture; some travel required.

Qualifications

• Minimum of Bachelor’s degree required; advanced degree desirable.
• 7+ years experience in regulated GxP pharmaceutical environment.
• Directing teams and managing budgets experience.
• Strong communication and leadership skills.
• Travel required.

Responsibilities

• Oversee Quality Systems, Clinical Quality, and Manufacturing Quality for FDA and international GMP compliance.
• Provide strategic leadership for CAPA, Change Management, Audits, and Risk Management.
• Lead quality strategy across development and manufacturing, including contract manufacturers.
• Primary liaison for regulatory inspections with domestic and ex-US authorities.
• Escalate quality issues to executive leadership as needed.
• Lead relationships with suppliers, CMOs, and labs to ensure quality.
• Maintain Quality/Technical Agreements with partners and suppliers.
• Support clinical trials to ensure GCP compliance.
• Participate in Site Leadership Team for continuous improvement.
• Analyze and report quality metrics to show system health.
• Lead GxP inspection readiness across all auditable areas.
• Manage budget for Quality Assurance.

Skills

Leadership

Quality Systems

GxP

Regulatory compliance

Risk management

Project management

Communication

Strategic thinking

Budget management

Education

Bachelor’s degree

Advanced degree in chemistry/engineering/biochemistry or related science

Tools

Microsoft Office Suite

GxP documentation systems

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.

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.