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Senior Quality Assurance Specialist

2 weeks ago

Richmond, California, United States Indivior Full time

About Indivior

Indivior is a global pharmaceutical company dedicated to developing medicines that help change patients' lives. With a vision of making evidence-based treatments accessible worldwide, we strive to eliminate the stigma associated with addiction.

We take our role as responsible stewards seriously and commit ourselves to cultivating our unique culture and highest standards of integrity. Our purpose is to bring science-based life-transforming treatments to patients.

  • Maintain inspection readiness of product programs and support management during inspections by competent authorities.
  • Ensure all regulatory audit findings are formally closed out.
  • Participate in internal audits and remediate any issues to agreed timelines.
  • Execute external audits of North American suppliers per the approved audit schedule.

Responsibilities

The Senior Quality Assurance Specialist will be responsible for planning, coordinating, leading, and managing the activities of the Operational Quality Section within the North American region. This includes ensuring that all relevant process raw materials, intermediates, and final products are manufactured, packaged, tested, and dispositioned in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and most of the world.

  • Provide final INDV oversight of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
  • Manage the quality elements of the Supply Chain for commercial products manufactured in the US.
  • Work with Supply personnel to foster dynamic working relationships with pre-wholesalers/wholesalers in North America to ensure continuity of patient supply of Indivior products within label requirements.

Requirements

  • Bachelor of Science degree, minimum, in a relevant scientific discipline.
  • 10+ years of quality experience in a regulated industry such as FDA, pharmaceutical or medical device.
  • Direct experience in finished product dispositioning.
  • Direct experience in reviewing manufacturing and packaging batch records as well as analytical testing results.