Quality Control Director

Aquestive Therapeutics; Portage (IN); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Control Director to oversee all aspects of the Quality Control Laboratory. This role requires strong leadership, problem-solving skills, and a deep understanding of regulatory compliance. The Director will manage a collaborative team, ensuring product quality and compliance while driving operational excellence. Candidates should have extensive experience in a GxP environment and a strong educational background in relevant scientific fields.

Qualifications

• 10+ years in regulated GxP industry, leading roles.
• Deep understanding of cGMP, ICH guidelines, and regulatory expectations.
• Minimum 5 years overseeing direct reports.

Responsibilities

• Lead and manage Quality Control function and programs.
• Oversee laboratory operations including budgeting and procurement.
• Conduct audits and inspections, ensuring compliance.

Skills

Problem Solving

Strategic Thinking

Critical Reasoning

Decision Making

Interpersonal Skills

Communication

Project Management

Organizational Skills

Education

Bachelor’s degree

Advanced degree in chemistry, engineering, biochemistry

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft PowerPoint

Microsoft Visio

Job description

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The Director of Quality Control is a leadership role, responsible for all aspects of the Quality Control Laboratory for Aquestive. This role maintains close working relationships with other leadership personnel to meet and maintain product quality, identify, solve, and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements.

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:

• 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.
• Lead Stability Program, providing data analysis and trending throughout various timepoints to key stakeholders.
• Lead 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.
• 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 response.

Qualifications:

• Minimum of Bachelor’s degree required. Advanced degree in chemistry, engineering, biochemistry, or related science fields are desirable.
• Minimum 10+ years of related work experience working in a regulated GxP industry in pharmaceutical drug product manufacturing as a lead role (Director, Associate Director or Sr. Manager).
• Deep understanding of cGMP, ICH guidelines, USP requirements and regulatory expectations.
• Demonstrated ability to direct a function, oversee projects and teams. Minimum of 5 years overseeing direct reports.
• Strong skillset in problem solving, strategic thinking, critical reasoning and decision making.
• Strong interpersonal skills and verbal/written communication skills.
• 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.

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.

Equal Opportunity Employer

Job Summary:

The Director of Quality Control is a leadership role, responsible for all aspects of the Quality Control Laboratory for Aquestive. This role maintains close working relationships with other leadership personnel to meet and maintain product quality, identify, solve, and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements.

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:

• 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.
• Lead Stability Program, providing data analysis and trending throughout various timepoints to key stakeholders.
• Lead 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.
• 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 response.

Qualifications:

• Minimum of Bachelor’s degree required. Advanced degree in chemistry, engineering, biochemistry, or related science fields are desirable.
• Minimum 10+ years of related work experience working in a regulated GxP industry in pharmaceutical drug product manufacturing as a lead role (Director, Associate Director or Sr. Manager).
• Deep understanding of cGMP, ICH guidelines, USP requirements and regulatory expectations.
• Demonstrated ability to direct a function, oversee projects and teams. Minimum of 5 years overseeing 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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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