Sr. Manager, Quality Control

Aquestive Therapeutics, Inc.•Portage, IN

61d

About The Position

The Senior Manager Quality Control is an experienced management 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.

Requirements

Minimum of Bachelor's degree required. Advanced degree in chemistry, engineering, biochemistry, or related science fields are desirable.
Minimum 7+ years of related work experience working in a Quality Control for a pharmaceutical drug product manufacturing operation.
Minimum of 3+ years experience in managing direct reports in a Quality Control Lab.
Deep understanding of cGMP, ICH guidelines, USP requirements and regulatory expectations for drug manufacturing and QC testing.
Demonstrated ability to lead a group, oversee projects and teams, and work cross-functionally to deliver results.
Expertise in the use of HPLC instruments and data collection software. Experience with the implementation and use of a Laboratory Information Management System (LIMS) is desirable.
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.

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.
Manage the execution of Stability Program, ensuring the performance of data analysis and trending throughout various timepoints to key stakeholders.
Manage the execution of the 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 and develop a strategy for laboratory operations.
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 responses.