CMC Quality Manager - Clinical Batch Release

Pulmovant; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Pulmovant is seeking a Manager, CMC Quality to oversee quality activities for drug substance, drug product, and finished product across the global clinical development program.

The role focuses on batch record review, clinical packaging and labeling, and release decisions in a fast-paced, start-up environment. Strong attention to detail, risk-based decision making, and collaboration with external partners are essential.

Qualifications

• Knowledge of Quality Systems and cGMP within a regulated environment.
• Hands-on experience with batch record review and product disposition/release for clinical or commercial pharmaceutical products.
• Familiarity with regulatory expectations (EU Annex 13, QP release) preferred.

Responsibilities

• Lead batch record review and clinical/partner disposition for drug substance and drug product, ensuring cGMP compliance.
• Support QP certification and release activities at CMOs for ex-US trials, coordinating timelines with Supply Chain and Clinical Operations.
• Review documentation for accuracy and ensure alignment with master batch records and commitments; drive timely issue resolution.
• Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations.

Skills

Quality Systems

cGMP

Batch record review

Disposition/release

Documentation

Cross-functional collaboration

Education

BA/BS in Chemistry, Biology, or Life Sciences

Job description

Pulmovant is seeking a Manager, CMC Quality to oversee quality activities for drug substance, drug product, and finished product across the global clinical development program.

The role focuses on batch record review, clinical packaging and labeling, and release decisions in a fast-paced, start-up environment. Strong attention to detail, risk-based decision making, and collaboration with external partners are essential.