Manager, Quality Operations

Aquestive Therapeutics•Portage, IN

About The Position

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.

Requirements

Bachelor’s degree (Science, Engineering, or related)
~7–10 years in GMP pharmaceutical manufacturing QA/QC
Prior people management or strong informal leadership
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.

Nice To Haves

Some travel required.

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.