Manager, Quality Operations

Aquestive Therapeutics, Inc.; Portage (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Portage, IN is seeking a senior QA/QC professional to lead day-to-day quality oversight of manufacturing and operations, ensuring cGMP compliance and robust risk management across a multi-site operation.

The role emphasizes leading deviations/investigations, batch release, and collaboration with Manufacturing, QC, and Supply Chain to sustain a state of audit readiness and continuous improvement.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 7–10 years of GMP pharmaceutical manufacturing QA/QC experience.
• Previous people management or strong informal leadership experience.
• Expertise in cGMP regulations (FDA/EU).
• Experience with quality systems (CAPA, deviations, change control).
• Experience in Manufacturing and/or QC operations.
• Strong PM skills and organizational ability with budget awareness.

Responsibilities

• Provide daily QA oversight of manufacturing and packaging operations across multi-site/multi-shift.
• Manage product quality release program ensuring on-time results and adherence to procedures.
• Provide real-time risk assessment and containment actions.
• Review and release batch records.
• Author/review/approve quality documentation for manufacturing.
• Ensure SOPs, batch records, and GMP compliance.
• Lead deviations, OOS, complaints, and investigations with robust root cause analysis and CAPAs.
• Manage QA personnel, priorities, staffing, and shift coverage.
• Oversee incoming materials QA/QC review and release to procedures.
• Coach on GMP decision-making and risk-based quality judgment.
• Monitor quality metrics and drive continuous improvement.

Skills

GMP QA

Project management

Leadership

cGMP regulations

Education

Bachelor's degree (Science/Engineering)

Tools

CAPA system

Change control

Deviations management

Job description

Aquestive Therapeutics, Inc.
Portage, IN 46368, USA

Description

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
• 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.

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.

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.