Quality Manager

Boston, MA

Responsibilities

 

  • Owns/maintains audit schedule
  • Distributes/ monitors completion of Vendor questionnaires and evaluates responses to determine frequency/type of re-assessment required
  • Conducts triage and forms working teams to determine additional action/oversight model as necessary
  • Plans/Schedules/conducts stakeholder meetings
  • Conducts audits, reports findings, and debriefs team on audit outcomes
  • Monitors and provides oversight of vendor audit records within the electronic Quality Management System (Trackwise/Veeva) to ensure timely closure of audit actions, including agendas, reports, responses, risk assessments, certificates and CAPAs
  • Aligns with Quality System Owner to support metrics activities for Audit and Inspection Management
  • Identifies and generates process related metrics- monitors for efficiency
  • Provide Inspection Support by conducting preparation activities and providing both front & back room inspection support

 

Requirements

 

  • B.S. (or equivalent degree) and 0 – 3 years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 5 – 8 years of relevant work experience, or relevant comparable background
  • Experience with Vendor /Audit management in the GxP space
  • Proven track record managing complex projects
  • Experience conducting audits and or willingness to obtain auditor certification
  • Experience participating on cross-functional teams
  • Experience using computerized systems such as EDMS, EQMS and ELMS.

 

 

 

 

Note: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, we will keep your resume on file for future opportunities and may contact you for further discussion.

Date Posted 4/8/2020
Salary $60.00/hr






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