Associate Director Device Quality Assurance (Drug-Device Combination Product)

Associate Director Device Quality Assurance (Drug-Device Combination Product)

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:

As a member of the Allakos team you will have the opportunity to lead and manage the quality aspects of developing drug-device combination products. This role would be the quality subject matter expert for the device development team.

Your Role:

• Quality focused project management expertise by acting as the Quality Single Point of Contact in device projects
• Establish device-related quality system and processes
• Provide technical device quality support for internal/external audits and vendor qualification
• Provide Quality oversight of suppliers including quality agreement, management of quality systems, documentation, and ultimate release of product
• Quality Assurance oversight to ensure adherence to design controls
• Quality expertise on risk management
• Support root cause analysis and discrepancy investigations.
• Communicate potential quality or regulatory issues that may affect product quality or regulatory compliance
• Review and approve protocols and reports
• Monitor and analyze device quality performance to demonstrate levels of control, capability, and compliance
• Establish, review, and update related SOPs and policies

Qualifications and Expertise:

• At least 8 years of relevant experience in the area of device quality
• Experience with biologics
• Bachelor's degree or higher
• Experience working with Contract Manufacturing Organizations
• Working knowledge of 21 CFR 820 and ISO 13485
• Demonstrated capability of applying risk management concepts and tools
• Excellent communication skills, both oral and written.
• Excellent interpersonal skills, collaborative approach essential.
• Comfortable in a fast-paced 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.

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.