Manager, Quality Assurance (Contractor)

Allakos 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:

This role is responsible for adhering to Allakos Quality Systems as well as health authority regulations. This position works closely with internal subject matter experts as well as contracting manufacturing organizations.

Your Role:

Perform master batch record review and executed batch record review
Support activities for dispositioning of Clinical batches bulk drug substances
Lead quality investigation of manufacturing deviations
Lead GMP audits, as required
Lead supplier qualification and reassessment activities as required
Review and updates GMP related SOPs and policies. Participate in projects that support continuous improvement efforts.
Provide CMO oversight of Drug Substance contractors.
Provide Quality Oversight of technology transfer activities
Review and approve qualification protocols and reports.
Lead technical change control process to ensure key GMP documents and processes are appropriately controlled.
Manage QA activities, including and prioritizing daily related to GMP activities
Collaborate with cross-functional team members to resolve quality matters
Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
Manage QA activities, including organization and prioritizing daily task related to GMP activities.
Some travel is required, domestic and international

Qualifications and Expertise:

At least 6-7 years of relevant experience in Quality Assurance in the Biotech/Life Sciences arena.
Bachelor's Degree or higher.
Working knowledge and understanding of ICH, FDA, and EU regulations.
Working experience in GMP environment.
Excellent communication skills, both oral and written.
Excellent interpersonal skills, collaborative approach essential.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

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.

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