Quality Assurance Manager

Full Time
Remote
Posted
Job description

A global pharmaceutical company is seeking a Sr. Manager, QA Compliance to join their team for a one year, remote contract position!

The Senior Manager, QA Compliance will oversee the execution of processes related to the qualification of GxP suppliers and support the internal audit program. This position will focus on GxP Suppliers and processes. This position is expected to effectively interact with cross functional team members, Suppliers, and service providers, to support commercial and clinical trials globally. This position will work with team members to ensure the company’s program process meets all written procedures and global regulatory requirements. This position will also have operational oversight including execution of vendor surveys, audit documentation, quality technical agreements, and audit schedules.

Key Responsibilities:

· Coordinate and execute audit schedules

· Project Manage the audit scheduled.

· Execute audit program, including internal and supplier audits and ensuring information is entered into the eQMS

· Monitor audit outcomes and audit findings to ensure timely CAPA follow-up, escalating as required

· Participate in the buildout of our annual audit plan to help ensure it is aligned with our strategy and objectives using a risk-based approach

· Aide in development and documentation of business processes to support qualification of a variety of GxP service providers

· Support stake holders in developing and implementing corrective and preventative actions

· Ensure contract auditors are appropriately qualified

Requirements:

· BA/BS in any Life Science discipline

· 10+ years in pharma/biotech industry

· 5+ years of auditing experience required

· Effective communication and follow-up

EOE

Job Type: Full-time

Pay: $70.00 - $80.00 per hour

Schedule:

  • 8 hour shift

Education:

  • Bachelor's (Required)

Experience:

  • Auditing: 5 years (Preferred)
  • Biotechnology: 10 years (Preferred)

Work Location: Remote

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