Quality Consultant SME Pharma Medical Devices

2 weeks ago

San Francisco, United States Excellis Health Full time
Job DescriptionJob DescriptionSalary:

Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark.  An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of solutions using our comprehensive knowledge and proven turnkey solutions to clients.  Excellis continues to expand its markets and services to meet the ever-changing industry needs.  With 70+ employees and historical growth of 25% plus year over year, Excellis anticipates continued growth in the United States and in Europe.


Role and Responsibilities

This consulting SME position will be responsible for providing quality expertise to both the EHS staff as well as our external clients. This position will be expected to understand current regulations, review, and interpret proposed regulations and provide expert input to those who are responsible for assuring regulatory compliance. This SME position will also be involved with interpreting and overseeing the associated quality compliance aspects of the regulations as they pertain to our client’s operations. Again, there is an expectation that this position understands the current quality compliance requirements, can review, and interpret proposed requirements and can provide expert feedback to those who are responsible for assuring compliance to the regulations.

  • Understanding and interpreting the FDA regulations for both Pharmaceutical and Medical Device products including those for developing, filing/approving, manufacturing, labeling, packaging, testing, storing and distributing the products
  • Understanding and interpreting the DSCSA regulations for pharmaceutical prescription products for the entire supply chain (manufacturer to consumer)
  • Understanding and interpreting the cGMP quality compliance aspects that are in part derived from the pertinent FDA regulations
  • Conducting internal and external audits to evaluate the degree of quality compliance and conformance to regulatory requirements and organizational QMS.   
  • Develop and recommend CAPA activities
  • Evaluate adequacy of QA procedures and policies. 
  • Support implementation of QMS
  • Monitor risk management activities
  • Working with the project teams to assure that the required compliance requirements are understood and adequately addressed as part of the project deliverables
  • Staying current with pertinent regulations and quality compliance trends within the industry

Qualifications and Education Requirements

  • Prior pharmaceutical and medical device regulatory affairs experience within the FDA regulated industry
  • Experience with the DSCSA regulations for prescription pharmaceutical products
  • Experience with Product Launch regulations
  • Prior quality compliance experience within the FDA regulated industry including conducting audits
  • Prior consulting experience
  • Self-starter with the ability to work independently on a project-by-project basis
  • BS degree or higher

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