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Key Responsibilities:
- Ensure manufacturing operations at CMOs comply with regulatory requirements and internal quality standards.
- Lead clinical lot disposition and batch record review, supporting QP certification for ex-US trials.
- Oversee GMP quality systems at external partners, including deviations, investigations, and change controls.
Qualifications:
- BA/BS in Chemistry, Biology, or Life Sciences with at least 8 years of pharma industry experience.
- Demonstrated knowledge of Quality Systems, cGMP, and Good Distribution Practices.
- Auditing experience and proven ability to manage CMOs, including batch review and issue resolution.
Skills Required:
- Strong analytical skills to identify key performance metrics and quality indicators.
- Excellent interpersonal, negotiation, and conflict management skills.
- Ability to work in a fast-paced start-up environment with tight deadlines and changing priorities.
Pulmovant
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.