Manager, Quality Operations

Job Summary:

Responsible for leading day-to-day quality oversight of manufacturing and operational activities to ensure compliance with cGMP, regulatory requirements, and company quality systems. Drives execution, inspection readiness, and continuous improvement across quality operations.

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:

• Daily GMP Oversight (Shop Floor + Operations), providing real-time QA oversight of manufacturing and packaging activities of a multi-site, multi-shift operation.
• Manage the product quality release program, ensuring on-time results and adherence to internal procedures.
• Provide quality risk assessment and decision support real-time, including containment correction measures.
• Review and release of batch records.
• Author, review and/or approve quality documentation related to manufacturing.
• Ensure adherence to SOPs, batch records, and GMP requirements
• Lead and/or oversee deviations, OOS, complaints, and investigations, ensuring robust root cause analysis and effective CAPAs.
• Manage Quality Operations personnel, setting priorities, staffing plans and shift coverage.
• Manage incoming materials quality review/approval to ensure materials are appropriately received, assessed, and released for use in accordance with applicable procedures.
• Coach team on GMP decision-making, risk-based quality judgement and investigator rigor.
• Monitor and report key quality metrics, including right first time.
• Identify trends and drive process improvements and simplification.
• Ensure continuous state of audit readiness, supporting health authority inspections and internal audits.
• Act as a primary QA partner to Manufacturing, Quality Control and Supply Chain and Quality Systems.

Qualifications:

• Education: Bachelor’s degree (Science, Engineering, or related)
• Experience: ~7–10 years in GMP pharmaceutical manufacturing QA/QC
• Leadership: Prior people management or strong informal leadership
• Expertise:
  • cGMP regulations (FDA / EU)
  • Quality systems (CAPA, deviations, change control)
  • Manufacturing and/or QC operations

• 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.