Donor Quality Professional

Department: Medical
Location: Cambridge, MA

Donation Quality Professional
Seres Therapeutics is well-positioned to become the first company to bring a microbiome drug to patients through our proprietary discovery, design, and CMC platforms. We identify key alterations in the microbiome that are associated with specific diseases, and are designing live bacterial ecologies as therapeutics. We are conducting multiple clinical trials including a recently approved Phase III study. Seres is a dynamic and well-financed biotechnology company located in Cambridge, MA.

 

What’s in it for you?
As the lead Donation Quality Professional, you will have the opportunity to develop a world class Donation Operations program. The partnerships you build with donor operations, donation collection facilities, testing laboratories and our leadership team will have a direct impact on the future of Seres.  This is a fantastic opportunity for someone who can provide Quality Assurance and oversight for donation collection facilities and internal operations, including implementation and monitoring of a Quality Management System.  If you are skilled at designing and building programs; and you are effective in problem solving then this is the perfect position for you.

And a few of the specifics:

  • Provides quality guidance and support for Donation Collection Facilities and Donation Operation's projects and programs, ensuring compliance with regulations and internal policies.
  • Develops and leads on-going quality oversight visits at donation centers, ongoing Quality Management Review meetings and develops audit plan for donor collection centers, testing laboratories and for Donation Operations.
  • Prepares quality oversight plans, checklists and summary reports for leadership. Ensures follow up activities are completed within timelines.
  • Assists with investigations and CAPA for Donation Operations deviations.
  • Attends ongoing operations meetings, medical review meetings of donors and performs detailed record reviews to support the Certificate of Conformance for Starting Raw Material.
  • Leads Donor Review Committee and maintains all supporting documentation and decisions.
  • Oversees document archival program for donor collection and donation operations.

 

Qualifications:

  • Bachelor of Science degree or equivalent in life sciences or engineering.
  • Minimum of 6-8 years of well-rounded Quality experience in the pharmaceutical or biotechnology industry with strong GxP experience. Experience working with plasma or blood regulations preferred.

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System