866-274-4009 Contact Us

Sr. Manager, Quality Management Systems

King of Prussia, PA, US
Apply Now >

Summary

The Center for Breakthrough Medicines (CBM) is seeking an experienced Senior Manager of Quality Systems to play a critical role in delivering a Quality Management System (QMS) that enables innovation, productivity, continuous improvement, and adherence to applicable regulations. The Senior Manager of Quality Systems will be responsible for building impactful relationships and collaborations across the organization while relying on practical experience to advance a proactive and quality beyond compliance strategy in a fast-paced organization

Responsibilities

  • Provide hands-on expertise in the day-to-day managing of data and document control including all aspects of issues management – change control, deviations, investigations, and CAPA.
  • Monitor the overall quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
  • Coordinate and provide training in support of the QMS.
  • Actively participate in the preparation of Quality Management Reviews and Quality Improvement plans.
  • Propose, initiate and prepare SOPs and other governance documents.
  • Review, approve and/or administer critical compliance documents in support of GLP, GCP and GMP operations according to CBM SOPs and regulatory requirements. This may include test specifications, batch record reviews, stability monitoring, authorizations to ship.
  • Perform vendor/CRO/CDMO audits and oversight.
  • Collaborate with other subject matter experts across the R&D organization to conduct cross-functional investigations, risk management and mitigation plans.
  • Represent Quality at designated cross-functional project/program team meetings.

Qualifications

  • 5-8 years of relevant Quality experience including managing GXP quality systems in the Pharma/Biotech industry.
  • Significant experience with both digital and paper based QMS solutions.
  • Diverse, Quality operations experience across functions in R&D – including CRO/CDMO oversight activities.
  • Clinical and commercial experience

Education & Experience

· Bachelor’s Degree in Life Sciences.

Sr. Manager, Quality Management Systems

King of Prussia, PA, US
Apply Now >