Senior Manager, Research and Development Quality - Cuyahoga Heights, United States - Spectrum Dynamics

Spectrum Dynamics
Spectrum Dynamics
Verified Company
Cuyahoga Heights, United States

3 weeks ago

Savannah Johnson

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Savannah Johnson

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Description
  • At Cuyahoga Heights, we are currently seeking a Senior Manager, R&D Quality (m/f/d) for our R&D Quality Management team in Marburg. This is a full-time, unlimited position at non-tariff Level 7. The expiration date for applications is [insert date].
  • In this role, you will be responsible for managing the integration of R&D quality systems, policies, and procedures in accordance with CSL Global Quality Management System (QMS) for Product Development.
  • You will also develop and maintain phase-appropriate quality systems, provide quality oversight for new product introduction, and act as the primary representative for R&D Quality in site quality management forums and discussions.
  • Additionally, you will manage the R&D quality unit, providing change control, batch technical release, deviation management, and risk management functions for Product Development in Marburg and Bern.
  • You will be accountable for the QA team's technical review and disposition of non-clinical toxicological material and clinical material, as well as managing the R&D self-inspection schedule for R&D functional areas.
  • As needed, you will assist with 3rd party quality audits and drive and implement quality continuous improvement projects.
  • Building strong business relationships with local and global quality sites where manufacturing operations are shared between sites is also a key aspect of this role.
  • In collaboration with key PD stakeholders,