Manager, GCP Quality Assurance

Location
Redwood City, CA, United States
Posted
Sep 22, 2020
Ref
690038475
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Description: Manager, GCP Quality Assurance

Responsibilities
  • Provides GCP/GLP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites
  • Manage QA activities, including organizing and prioritizing daily tasks related to GCP activities
  • Assist in the development of CQA audit plans (internal and external)
  • Perform supplier qualification audit in support of the QA Vendor Qualification program and routine vendor audits
  • Monitor audit responses and corrective action to ensure accuracy and completeness.
  • Conduct investigations of GCP-related issues (i.e., non-compliance, quality events) and work with subject matter experts to develop corrective and preventative action plans
  • Provide GCP guidance to internal departments for all phases of clinical drug development.
  • Help maintain inspection readiness
  • Develop, review and implement GCP related SOPs and policies
  • Work in collaboration with clinical operation, regulatory affairs, and other stakeholders to ensure compliance to GCP
  • Conduct reviews of project-related Clinical Development documents, as applicable
  • Maintain flexibility to perform other / additional tasks as assigned.
  • Some travel required, domestic and international


Required Experience
  • At least 6 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
  • Minimum of 2 years experience in GCP auditing
  • Bachelor's degree or higher
  • Working knowledge of FDA/EMA regulatory requirements and ICH guidelines
  • Excellent communication skills, both oral and written.
  • Excellent interpersonal skills, collaborative approach essential.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Self-motivated with attention to detail and a strong sense of ownership in areas of responsibility.

This position can be located remotely within the United States.

The salary is competitive and commensurate with experience and qualifications.

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