Quality Assurance Systems Manager
ARMO BioSciences is seeking a QA Systems Manager to implement and manage GMP quality systems: CAPA, deviations, change control, Batch Record Review.
Responsibilities and Job Functions
- Implementing Master Control for Quality Systems
- Creating forms and implementing Quality Systems: CAPA, deviations, change control, Batch Record Review
- Working with CMOs
- Writing Quality Systems SOPs
- Manage Change Control System
- Facilitates the investigation process
- Being involved with internal and regulatory audits and inspections as required.
- Ensures compliance to internal SOPs and regulatory requirements.
- Ensures the adequacy of investigations performed in relation to manufactured drug product and drug substance to support the batch release process.
- Perform additional duties as assigned.
Knowledge, Experience and Skills
- Bachelor’s degree in a Life Sciences discipline or equivalent
- 5-7 years of GMP Quality Systems experience in an FDA regulated GMP environment.
- Experience implementing and managing quality systems: CAPA, change control, Batch Record Review.
- Experience with on-site FDA inspections
- Experience in biotechnology, biologics, or pharma
- Experience with writing and revising Quality Systems SOPs
- Experience with Master Control
- Experience with CMO and supplier quality
- Experience at both small and large company – understand different facets of quality systems and what the big picture looks like
- Personable, organized, and detail oriented
- Excellent written and verbal communication skills
- Local candidates only
Being a member of the ARMO BioSciences team is a unique opportunity to make a difference in the life of patients suffering of grievous diseases. We demonstrate a strong sense of personal ownership in everything we do and as such expect honesty, integrity, passion and scientific excellence from our employees. ARMO BioSciences is an equal opportunity employer. We are committed to building a workforce that respects individual skills and diversity and commitment to teamwork. We hire outstanding people and subscribe to a rigorous, fast-paced work ethic where the science leads the business.