Scientific Data Management Lead

3 days ago


Petersburg, Virginia, United States Civica Rx Full time
Job Title: Manager - Scientific Data Management

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. As a leader in the healthcare and pharmaceutical industry, we are committed to ensuring that quality generic medications are accessible and affordable to everyone.

Job Summary:

We are seeking an experienced Manager - Scientific Data Management to join our team. The successful candidate will be responsible for managing the manual and automated Visual Inspection program, including defect library, knapp test kits, AQL strategy, and inspection qualification. This is a leadership role with a focus on the start-up, execution, and maintenance of GMP inspection programs, compliant to USP 790 and 1790.

Key Responsibilities:
  • Assist in classification of rejected units.
  • Develop, write, review, and approve SOPs, specifications, and other documents to support the manual/automated visual Inspection, packaging, and AQL sampling.
  • Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
  • Actively participate in new equipment and process qualifications.
  • Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
Requirements:
  • Advanced knowledge of Visual inspection principals, practices, and applications.
  • Knowledge of Lean Six Sigma Tools and DMAIC problem solving approaches.
  • At least 3 years previous management or leadership experience including leading or working effectively with a cross functional group.
  • Bachelor's degree in a science related field; Solid understanding of basic requirements of regulatory agencies.
About Civica Rx:

Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.

We are led by an experienced team of healthcare and pharmaceutical industry leaders and have partnered with over 55 health systems to achieve our mission. Our manufacturing facility in Petersburg, Virginia, is currently in late-stage construction and hiring for the site is well-underway.

To learn more about Civica Rx and our mission, please visit our website.



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