Senior Manager, Quality Assurance
Senior Manager, Quality AssuranceAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:As a member of the Allakos team, you would be responsible for all quality oversight activities related to Large Scale manufacturing.
- Manage the disposition activities of batches manufactured by contract manufacturer
- Manage QA activities, including organizing and prioritizing daily tasks related to GMP activities
- Provide Quality oversight of technology transfer activities
- Provide master batch record review and executed batch record review
- Review and approve qualification protocols and reports
- Lead technical change control process to ensure key GMP documents and processes are appropriately controlled
- Lead quality investigation of manufacturing deviations
- Lead GMP audits, as required.
- Collaborate with cross functional team member to resolve quality matters
- 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 methods, specifications, validations, reference materials and test results.
- Review and update GMP related SOPs and policies
- Some travel required, domestic and international
Qualifications and Expertise:
- At least 8 years of relevant experience in quality assurance in the Biotech/Life Sciences arena
- Bachelor's degree or higher
- Extensive experience working with Contract Manufacturing Organizations
- 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.