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eQMS Project Manager

eQMS Project Manager

  • 2021-24181
  • Benicia, California, United States

Bio-Rad is seeking an eQMS Project Manager. This role will be responsible for implementing a global eQMS.

 

Establishing requirements and seeking agreement from all stakeholders, sourcing and qualifying suitable 3rd party providers. Governing, maintenance and correct execution of several Quality process improvement programs including but not limited to applicable quality plans, global quality and regulatory metrics, technical reviews, strategy development.

Responsibilities

  • Document requirements for the e-QMS according to Lean 6S or Configuration Management principles.
  • Partner with all stakeholders to create and deliver a start to finish electronic global solution for agreed elements of the QMS.
  • Leverage existing capabilities and lessons learned, partner with stakeholders to develop future state and industry best-practice processes that are foundational for the eQMS (CAPA, complaints, NCs, audits, eDHF as applicable).
  • Create and manage a Quality Plan governing the e-QMS implementation including other project management activities such as ensuring all functions are planning and executing (pitch, catch, decommission, maintain) as per plan.
  • Develop and implement a technical review process that facilitates collaborative reviews that ensure effective, efficient and data-driven decision making.

Qualifications

  • Bachelor’s degree or Masters in a scientific discipline is required.
  • Certification or proven experience in requirements-based improvement programs such as CMII, 6-sigma or equivalent.
  • 15 or more years in quality or regulatory functions.
  • Proven ability to create and implement large scale improvement programs.
  • Deep understanding and demonstrable experience of applicable requirements in ISO 13485, MDSAP, 21CFR820.
  • Ability to work and communicate collaboratively and effectively in complex work environments.
  • Curious personality and passion to deliver continuous improvement.
  • Effective Communication Skills (Written and Verbal).
  • Experience working with Global Teams.
  • Track record of influencing and consensus building.

 

About Bio-Rad:

 

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

 

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

Agency Non-Solicitation: 

 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

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