Associate Director, Quality Assurance

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties:

• Host and provide responses to client audits and regulatory inspections.
• Oversee Quality Management System at CSBio encompassing quality investigations including...

Global Life Science Hub has taken on a fascinating, exclusive retained assignment with a rapidly growing life science organisation that provides unique lab services to a vast range of pharma's, from start-ups to top 10. They are looking to further appoint 230 new allocated positions across the United States in the next 24 months.

Due to this exciting growth stage, they’re now searching for a brand-new seasoned Quality Assurance Manager/Director that will be responsible for assisting the Vice President with ensuring quality processes are maintained. The appointed candidate will also be liable to act as the chief internal regulatory advisor in the Senior Director’s absence and will drive growth in the US and Europe.
Responsibilities

• Leads and directs activities of the Quality and Regulatory Services department
• Performs routine assessment of QRS team members and develops team development plans
• Assesses and responds to issues...

Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP Quality Assurance activities, ensuring meticulous adherence to standards that drive our growth objectives forward. Beyond external engagements, you'll be a key collaborator, bridging departments to fortify our operational integrity. Your focus on developing our QA infrastructure will be instrumental in realizing our strategic initiatives. If you're ready to bring your analytical prowess to the table, join us and report directly to the head of RA/QA as we navigate the complexities of quality assurance with precision and purpose.

Requirements

What will you be doing?

• Development, implementation, maintenance of quality assurance infrastructure & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the...