Associate Director / Senior Manager, Quality Assurance
Associate Director / 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 will be responsible for quality oversight activities related to Method Validation, Release testing, and Stability for Drug Substance and Drug Product.
- In collaboration with SME, provide QA review and approval of transfer and or validation protocols/reports to ensure compliance with current regulatory guidance and industry practices
- Provide Quality oversight of method transfer activities
- Review data packages for compliance, as applicable
- Review change controls
- Lead quality investigation of GMP testing deviations
- Assist in GMP audits as applicable
- 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 release testing, and stability
- Reviews and assess specifications, validations, reference materials and test results.
- Review and assess temperature excursions
- Review and update GMP related SOPs and policies
Qualifications and Expertise:
- At least 8 years of relevant experience in the area of 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.