Quality Assurance Manager

4 weeks ago

Petersburg, United States Civica Rx Full time
About Civica Rx:

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.

We are seeking a Quality Assurance Manager to join our team at our Petersburg, Virginia site. This role will be responsible for leading the quality document control and training team and developing quality systems and processes to enable the manufacture of sterile injectable medications.

The Quality Assurance Manager will work closely with our team to establish and maintain a quality system framework that meets regulatory standards and expectations for the development and reliable supply of quality medicines.

Key Responsibilities:

  • Manage and oversee day-to-day activities associated with document control, records retention, batch record management, and training.
  • Develop and/or improve quality processes and systems.
  • Responsible for oversight of Document controls and training management system at the Petersburg site.
  • Track, trend, and analyze quality system data and information for the site.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Requirements:

  • 8 years' experience in pharmaceutical or medical device industries.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Quality system management experience.
  • Minimum of 3 years' experience in a supervisory role.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

Preferred Qualifications:

  • Experience in Veeva Quality Management Systems.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a dynamic and growing organization.
  • A collaborative and supportive work environment.

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