Manager/Sr. Manager GMP Quality Assurance # 1018

Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. We are looking for a contractor or regular full time candidate to fill this position.


  • Provide master batch record review and executed batch record review
  • Manage the disposition activities of batches manufactured b contract manufacturers
  • Mange QA activities, including organizing and prioritizing daily tasks related to GMP activities
  • Lead technical change control process to ensure key GMP documents such as product specifications and certificate of analysis are appropriately controlled
  • Assist in quality investigation of manufacturing deviations
  • Assist in GMP audits, as required.
  • Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations
  • Maintain appropriate development phase GMP compliance for product manufacture, testing, and stability; reviews and assess production and testing
  • Review and update GMP related SOPs and policies
  • Approximately 10-15% travel required, domestic and international

Qualifications & Expertise:

  • At least 6 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
  • Bachelor’s degree or higher, or relevant experience
  • Biologics experience highly desired
  • Working knowledge of cGMPs (US and EU)
  • Working experience in GXP environment
  • Excellent communication skills, both oral and written
  • Excellent interpersonal skills, collaborative approach essential
  • Comfortable in a fast-paced small company environment with minimal direction
  • And able to adjust workload based upon changing priorities
  • Self-motivated with a strong sense of ownership in areas of responsibility

The salary is competitive and commensurate with experience and qualifications. Interested applicants please send resume to and reference Job #1018

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.