Director, CMC Quality
New
P
PulmovantBiotechnology
Remote, USFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 8 years
- Required Skills
- Risk Management
Requirements
- BA/BS degree in Chemistry, Biology, or Life Sciences.
- At least 8 years of experience in the pharmaceutical industry.
- Demonstrated knowledge of Quality Systems and cGMP within a regulated environment.
- Knowledge of Good Distribution Practices.
- Auditing experience.
- Experience providing quality oversight of CMOs, including audits, batch review, and issue resolution.
- Strong analytical skills with the ability to identify key performance metrics and quality indicators.
- Proven leadership, negotiation, and conflict management skills with experience influencing across functions.
- Exceptional interpersonal, active listening, and questioning skills.
- Experience in environments requiring problem-solving and risk-based solutions.
- Excellent organizational and time management skills with attention to detail.
- Ability to work comfortably under pressure in fast-paced, start-up environments.
Responsibilities
- Ensure manufacturing operations at CMOs and partners comply with regulatory requirements and internal quality standards.
- Lead clinical lot disposition and batch record review to support release and QP certification activities.
- Oversee GMP Quality Systems including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations.
- Conduct cGMP audits of vendors, CMOs, contract testing labs, and logistics providers, and manage Quality Agreements.
- Provide quality and technical input for cross-functional project teams and review documentation like protocols and SOPs.
- Partner with CMC, Supply Chain, and Regulatory Affairs to manage product quality risks and mitigation plans.
- Lead regulatory inspection preparation and readiness activities.
- Support the review of CMC sections for regulatory submissions like INDs and IMPDs.
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