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RA/QA Integrations Program Manager

RA/QA Integrations Program Manager

  • 2022-28233
  • Minnesota, United States

Bio-Rad is seeking an RA/QA Integrations Program Manager (Associate Director).  This role will be responsible for developing the Regulatory and Quality Integrations program to include M&A methodology, playbook and tools, as well as leading due diligence and integration planning/execution for the RAQA organization.  Additionally, the Program Manager will actively support RA/QA PMO projects and initiatives as needed.

 

Note: This position is a fully remote role. 

Responsibilities

  • Establish partnerships within the RA/QA organization to define, implement and execute diligence and integrations.
  • Appropriately identify integration risks and requirements for each target through diligence, audits, and/or gap assessments based on relevant scoping factors, e.g., target size, product mix/complexity, QMS maturity, regulatory oversight, integration goals, etc.
  • Develop integration metrics, dashboards, and mechanisms to communicate integration status/risks/trends to RAQA leadership.
  • Define and continuously improve the tools and templates for executing due diligence and integrations.
  • Apply accepted Project Management and Change Management methodologies to integration projects.
  • Coach and develop RA/QA staff supporting integration projects.

Qualifications

  • Bachelors or Master’s Degree in a scientific discipline or equivalent work experience.
  • 10+ years in Quality and/or Regulatory roles with demonstrated progressive responsibility.
  • M&A diligence and integrations experience for Quality and Regulatory functions highly preferred.
  • Seasoned experience in application of ISO standards and regulatory requirements within the In Vitro Diagnostic and/or Medical Device space (MDSAP, EU, and US regulatory requirements a must, additional geographies a plus).
  • Demonstrated experience developing, executing and closing projects within a program portfolio.
  • Strong communication, relationship-building, and influencing skills in a global teams environment.

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. 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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