San Diego, California
Quality Assurance Manager
If culture and mentorship are your priorities – you’ve found your match. This pioneer company in Immunoncology is looking to support and promote a talented Sr. QA Manager who will assist in the development and implementation of cGMP manufacturing. The ideal professional will have a strong background in clinical scale GMP manufacturing and knowledge of FDA and ICH regulatory requirements.
What you will do:
- Work with company’s executives and other senior managers to provide recommendations and strategic directions to improve the culture of compliance and establish the quality by design (QBD) foundation.
- Develop, implement, and coordinate the quality programs in compliance with federal and global regulatory requirements to support clinical manufacturing at CMO sites. Proactively identify and alert management of quality issues in time to resolve potential adverse effects to the product quality and/or the business milestones.
- Work closely with CMO(s) to coordinate cGMP related activities to make sure that company’s timelines are met.
Who you are:
- Bachelor’s or higher degree in Biology, Chemistry, or related Life Sciences degree with at least 8-10 years of experience working under GMP
- Strongly prefer candidate with hands on experience with mammalian cell culture.
- Extensive clinical scale GMP manufacturing experience
- Understanding a phase-appropriate cGMP concept
Why work here:
- Small team environment encourages interdivisional collaboration. You’ll always have your voice heard and can wear many hats!
- Impact: Have a positive influence both as part of a lean team where your voice can be heard, as well as on the company as a whole.
Please email your resume to email@example.com if you’d like to work alongside some of the finest scientists in the life sciences industry!
Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!