Senior Quality Lead — GMP Compliance & Batch Release

Aquestive Therapeutics

Portage (IN)

On-site

USD 95,000 - 135,000

Full time

8 days ago

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Job summary

Aquestive Therapeutics is seeking a Quality professional to ensure compliance with GMPs and CFR 210/211 for pharmaceutical manufacturing and release. The role involves reviewing documentation, leading batch disposition, and coordinating with Quality Control, Manufacturing and Supply Chain to ensure timely release.

Responsibilities include maintaining the quality system, managing Change Control, CAPA and investigations, and supporting audits.

Qualifications

Candidates must have strong knowledge of GMPs and CFR 210/211 for pharmaceutical manufacturing, testing and release.
Ability to make sound, independent quality decisions and ensure compliance with regulations.
Experience with batch review, release and related quality documentation is preferred.

Responsibilities

Verify that all batches meet GMP and regulatory requirements by reviewing manufacturing and testing records.
Provide leadership summaries for batches not meeting standards and support final disposition decisions.
Coordinate batch release with Quality Control, Manufacturing, and Supply Chain.
Communicate batch release statuses to external partners and respond to questions promptly.
Oversee quality system processes (e.g., Change Control) and contribute to CAPA, investigations and audits.