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Senior Quality Assurance Manager

  • Type Contract
  • Salary US$80 - US$95 per hour
  • Location Cambridge, Massachusetts
  • Sectors Quality Assurance (QA)

Senior Quality Assurance Manager Greater Boston Open-Ended Contract (Temp to Perm)

Are you interested in a challenging role within a small therapeutic company focused in the Greater Boston Area? A role to serve as the SME in a Quality Assurance group to lead compliance activities in accordance with business objectives? My client is an immuo-oncology company focused in Cambridge looking to add a Senior Manager of Quality Assurance to their team on an open-ended contract.

Responsibilities

  • Develop and implement Quality KPIs
  • Provide guidance and oversight to Quality organization that are both compliant and in alignment with standards and goals
  • Review, approve and identify compliance gaps and proactively take steps to ensure internal and external standards are met
  • Lead quality review of documentation; including batch records, analytical records and any supporting documentation to ensure compliance
  • Lead QA oversight in support of product development and in-process release and stability testing of raw materials and drug product
  • Lead QA oversight for contract manufacturing operations and lead QA support of tech transfer to CMOs and qualification of manufacturing activities
  • Identify compliance issues, investigate and propose solutions, and lead closure of deviations and completion of CAPAs
  • Take leadership for all on-site activities of document control
  • Perform Quality audits of CMOs, CTOs and Suppliers

Qualifications

  • Minimum 8+ years of Quality Assurance related experience in cGXP environment
  • BS degree in Chem, Bio, Quality and or Reg
  • Potential to travel up to 25% at the beginning of the engagement
  • Excellent understanding of Quality Systems and GXP requirements and regulations
  • Strong communication, presentation, interpersonal, and organizational skills.

If you or someone you know is interested in this particular role, please send an updated resume to the attention of Ahmed Hassan and team at Real Staffing, Boston OR apply below.

Sthree US is acting as an Employment Business in relation to this vacancy.