We have always walked our own path, at Alector. That’s what led us to the bold thinking and fresh, new approach of empowering the body’s immune system to fight disease. 

Join us in our mission to eliminate neurodegeneration and cancer through immuno-neurology and immuno-oncology. We are developing a broad portfolio of programs, currently in various stages of clinical trials. 

Alector is based in South San Francisco, CA. We were founded in 2013 by thought leaders in biotechnology, neuroscience, and antibody drug discovery.

Alector

QA Engineer

Oversee CQA approach and audit programs ensuring regulatory compliance.

• Executes the direction for CQA’s approach in collaboration with the Quality Leadership Team/CQA Management Team and relevant stakeholders.
• Directs the development and implementation of this approach to ensure an effective CQA oversight and audit program which complies with regulatory requirements and stakeholder expectations.
• Manages the audit program including oversight of Contract Auditors, management of audit plans, reports, and responses, as well as evaluation and refinement of Audit tools and templates (for Clinical Investigator Sites, Vendors, and Internal Audits).
• Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)
• Provides QA support to PV for process improvements, compliance initiatives, issue resolution, etc.
• Assures the creation and implementation of the appropriate strategic risk-based support model for each program.
• Ensures the development of short and long-term risk-based quality strategies in support of development programs based on current regulatory interpretations.
• Provides strategic direction to ensure that the appropriate processes and procedures are in place for CQA
• Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CQA key stakeholders and development functions.
• Support Sponsor GCP Inspection Readiness and Management for Clinical Sites and Sponsor activities including review and staging of regulatory authority expected and actual inspection requests (FDA, EMA, MHRA), organizational preparation activities (mock inspection, storyboarding, etc.) and management of in-process global regulatory authority inspections at Clinical Sites.

Alector Jobs in New York City

Alector

Associate CQA Director -Temporary

Alector