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Quality Systems Manager

Employer
AnaptysBio, Inc.
Location
San Diego, CA, US
Start date
Oct 15, 2019

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

We are seeking a Quality Systems Manager to establish our quality systems, processes, and procedures to ensure compliance with regulations. The manager will work with internal and CMOs/CROs team in handling quality system events, including design controls, deviations, investigations, change management, CAPA, quality metrics, audits, and risk management.

Requirements

Education & Experience
  • Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
  • Eight years of Quality Assurance experience in the bio-pharmaceutical industry
  • Experience working with CMOs/CROs


Knowledge and Competencies
  • Strong working knowledge of quality systems and regulations (GMP 210 & 211, GCP, and/or GLP)
  • Ability to work and make decisions independently and as part of a team
  • Strong and effective verbal, interpersonal, and written communication skills
  • Strong problem-solving skills and analytical skills applied to investigations
  • Self-motivated and able to organize and prioritize multiple tasks
  • Strong collaboration, strategic thinking, leadership, and teamwork skills
  • Advanced computer skills

Company

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. We are developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, our PD-1 agonist program in a Phase 2 trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, our BTLA agonist program, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Our preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Our corporate vision is to transform patient health by delivering innovative immunology therapeutics. Find out more about us by following us on Twitter.

 

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Company info
Website
Phone
858-362-6295
Location
10770 Wateridge Circle
Suite 210
 San Diego
California
92121
United States
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