Director, CMC Quality & Compliance (Biotech)

Pulmovant; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Pulmovant is seeking a Director, CMC Quality to provide quality oversight of external vendors and ensure cGMP compliance across drug substance, drug product, and finished dosage forms in a global clinical program.

This hands-on role requires strategic yet practical quality systems leadership, audit program management, and collaboration with CMC, Supply Chain, and Regulatory Affairs to support INDs and IMPDs.

Qualifications

• BA/BS degree in Chemistry, Biology, or Life Sciences with at least 8 years of pharma experience.
• Auditing experience required.
• Experience providing quality oversight of CMOs, including audits, batch review and issue resolution.

Responsibilities

• Ensure CMOs and partners comply with regulatory requirements and Pulmovant quality standards.
• Lead clinical lot disposition and batch review with regulatory alignment for ex-US trials.
• Oversee GMP Quality Systems activities at external partners (deviations, investigations, change controls, OOS/OOT).
• Conduct and document cGMP audits of vendors, CMOs, testing labs, packaging/labeling, and logistics providers; negotiate/maintain Quality Agreements.
• Provide quality input to cross-functional project teams and review protocols, reports, test methods, specs, master batch records, and SOPs.
• Partner with CMC, Supply Chain, and Regulatory Affairs to assess product quality risks and develop mitigation plans.
• Lead quality initiatives including inspection readiness and regulatory inspections.
• Support review of CMC sections of regulatory submissions (INDs/IMPDs) and responses to health authority questions.

Skills

Quality systems

cGMP

Auditing

CMO oversight

Risk-based quality

Leadership

Negotiation

Interpersonal skills

Education

BA/BS in Chemistry, Biology or Life Sciences

Job description

Pulmovant is seeking a Director, CMC Quality to provide quality oversight of external vendors and ensure cGMP compliance across drug substance, drug product, and finished dosage forms in a global clinical program.

This hands-on role requires strategic yet practical quality systems leadership, audit program management, and collaboration with CMC, Supply Chain, and Regulatory Affairs to support INDs and IMPDs.