Quality Control Director

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/InProcess 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 ThirdParty 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 Bachelors 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 prioritysetting 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 Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drugfree 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.

Required Experience:

Director