Job

A fast growing and innovative biopharmaceutical company is looking to hire an experienced Clinical Quality Assurance Manager to join their team.

Position Summary:

This person with work cross functionally with the Clinical Quality and Corporate Quality team. Some of the main responsibilities include:

• Plans and transforms policies, systems and procedures associated with clinical quality
• Contributions in external audits
• Completes internal audits
• Provides knowledge and leadership to various departments to assure clinical trials are conducted in compliance with Good Clinical Practices (GCP)
• Assitis Contract Research Organization staff in the proper execution of GCP
• Works with internal stakeholders in complying with and developing new SOPs
• Demonstrates the highest level of detail within clinical quality compliance

Key Responsibilities:

Position specific requirements

• Familiarity in conducting clinical trials
• Knowledge with internal audits of clinical quality systems
• Involvement in working with CAPA closure and audit finding remediation
• Capable of maintaining databases

Other valuable capabilities

• Familiarity with electronics solutions supporting clinical trials
• Extensive knowledge of MS Word, Excel, Access, Visio and PowerPoint
• Proven ability to work cross functionally

Knowledge, Skills and Experience:

• Minimum 5 years’ experience in Biopharma industry with 5 years’ experience in clinical quality assurance or clinical operations.
• Bachelor’s degree required, science related field preferred