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Regulatory Affairs and Quality Assurance Project Manager

Regulatory Affairs and Quality Assurance Project Manager

  • 2020-13201.3
  • Hercules, California, United States

Bio-Rad is seeking an experienced Regulatory Affairs and Quality Assurance Project Manager to lead standardization and implementation of global process improvements that drive product and process quality and compliance across our diverse global network. This role will collaborate with multiple sites in the US, Europe and Asia Pacific which will require remote meetings and future occasional travel.

Responsibilities

  • Leads complex projects in the medical device field, including process improvements and operational projects to improve process and product quality.
  • Monitors project scope, timeline, and cost to assure project completion on schedule and within desired parameters.
  • Understand requirements and processes for Best in Class Quality Management Systems and regulatory compliance
  • Lead small medium, and large cross functional and multi-site initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
  • Develop high level reporting strategy and metrics to be reported to enable executive management to take action to improve process and product quality.
  • Work with cross functional team to implement metric reporting.
  • Assisting RA/QA leadership with communication of project status and needs to executive management team members.
  • Develop and deliver training content for Quality Systems processes and regulatory compliance.

Qualifications

  • Bachelor's degree or equivalent in Biology, Chemistry, or related field.
  • 8+ years' experience in a medical device or pharmaceutical manufacturing industry or equivalent combination of education and experience.
  • Advanced knowledge of and application of Quality Systems Engineering, Lean Six Sigma and Metrics/Statistics Reporting required.
  • Proven ability to collaborate and influence with or without authority, facilitate groups with diverse perspectives and align teams.
  • Regulatory experience or RAC is desired.
  • Demonstrated project management skills are required with PMP preferred.
  • Salesforce, SAP and Power BI experience is a plus.
  • Experience managing international teams is a plus.
Vaccination Requirement: 
 
Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.
 

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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