Manager, GMP Quality Assurance
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
- Provide master batch record review and executed batch record review
- Manage the disposition activities of batches manufactured by contract manufacturers
- Manage 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 as well as applicable sections of regulatory submissions for compliance with documentation, established standards, and regulations.
- Maintain appropriate development phase GMP compliance for product manufacture, testing, and stability; reviews and assess production and testing methods, specifications, validations, reference materials and test results.
- Review and update GMP related SOPs and policies
- 10-20% travel required, domestic and international
- At least 6 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
- Bachelor's degree or higher
- 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 email@example.com
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.