Manager, Clinical Quality Assurance - San Diego, CA | Biospace
Get Our FREE Industry eNewsletter

Manager, Clinical Quality Assurance

PaxVax, Inc.

Apply
Location:
San Diego, CA
Posted Date:
11/11/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Clinical Operations, Pharmaceutical, QA, Quality Assurance,

Job Description

The Manager, Clinical QA will be responsible for supporting the Clinical Operations Department, and work collaboratively in the design, execution and reporting of clinical trials at PaxVax, Inc.  

Responsibilities:
•   Support Clinical Operations with quality assurance information, as needed.
•   Review clinical study reports and regulatory submissions.
•   Develop audit plans for appropriate clinical trials.
•   Lead and execute clinical site audits.
•   Lead and execute internal audits.
•   Lead and execute external vendor audits.
•   Ensure Investigational Product is shipped and returned according to SOPs and regulations.
•   Document all product complaints and deviations related to Investigational Product.
•   Review and revise standard operating procedures as required.

Requirements

•   Minimum of Bachelor Degree (BA or BS) required in scientific field.  
•   Minimum of six (6) years’ experience in a FDA regulated pharmaceutical/biotechnology field.
•   Strong understanding and application of cGCPs standards.
•   Experience in cGCP QA oversight and auditing roles.
•   Experience with effective quality system for a FDA regulated environment.
•   Solid computer skills including MS Office required.

Technical Skills and Knowledge:
•   Has the ability to make sound decisions based on experience and applicable regulations, i.e. must be able to review, and approved CAPAs, deviations, change controls, etc. with minimal supervision.
•   Capable of using an electronic quality management system.
•   Has the ability to deal with competing timelines and multiple assignments.
•   Strong communication (written and oral), negotiation, organizational, and interpersonal skills.
•   Must be able to collaborate and work effectively with multiple departments throughout the organization.
•   Must be able to work independently and as part of a team.

Travel:
•   Domestic travel is required (approximately 30%).