Director of Quality
Las Vegas, Nevada / Bespoke Pharmaceuticals - Las Vegas, NV / Full Time
We have recently partnered with one of our customer's to provide direct hire recruiting services. By applying to this position you understand you are not applying to a direct full-time role within CAI. During the screening process, details surrounding the client's location and benefits will be provided. Our client is looking for a Director of Quality who will be responsible for ensuring the highest quality standards throughout development and manufacturing processes.
This leadership role requires a comprehensive understanding of quality management systems, quality assurance, quality control, microbiological, regulatory compliance, and training requirements for biopharmaceutical fill/finish processes.
Position Requirements:
- Bachelor’s or advanced degree (preferred) in a relevant scientific or in an engineering discipline.
- Extensive experience (typically 10+ years) in quality assurance and quality control within the biopharmaceutical industry.
- Strong understanding of cGMP, ICH guidelines, and other relevant regulatory requirements.
- In-depth knowledge of Terminal Sterilization methodologies (electron beam, ethylene oxide, VHP, etc.) is highly desired.
- Working knowledge of microbiological and quality requirements for 501B compounding.
- Proven experience in successfully leading and developing high-performance teams.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Experience with regulatory inspections and interactions.
- Must live in Las Vegas, NV area, relocation assistance available.