Boston, MA: Sr Manager of QA (227173)

Life Sciences & Technology | Quality Assurance & Quality Control

Location: Remote (Greater Boston Area)

Duration: 6+ months

Job Description: 

A Black Diamond client is looking for a Senior Manager, Quality Oversight to join their quality assurance team as they continue to advance proactive quality oversight of our clinical programs.  This individual will be responsible for GCP/quality activities related to oversight and management of clinical trial execution, including development and execution of study level audit plans, monitoring/trending of quality and compliance metrics, deviation/CAPA management and inspection readiness.  Experience with key performance indicators, metrics analysis, and project management of quality improvement initiatives is advantageous.

Responsibilities:

  • Execution and/or oversight of quality monitoring and assurance of clinical trial execution for assigned programs
  • Execution and/or oversight of Clinical Investigator audits, Documentation Audits and other study-specific or process audits
  • Engages with study teams and functions for proactive inspection readiness across assigned programs/areas
  • May serve as GCP Quality Management System representative
  • Events and CAPA review/approval
  • Participate in collaborative review of impacted SOP/WI
  • Assess /approve proposal, and make recommendations for Quality and Performance Indicators
  • Review/facilitate Risk Profile and Performance updates for presentation to quality leadership and governance as needed
  • Conduct ongoing monitoring of regulations and update policy statement as required
  • Provides support for Health Authority Inspections (preparation, support and follow-up activities)
  • Develops, maintains and ensures execution of strategic protocol specific audit plans and audit closure/summary reports for assigned people/programs
  • Monitors and trends events related to their process and identifies/proposes Corrective actions to address
  • Identifies risks/communicates gaps to Quality System Owner

Requirements:

  • Auditing-language/roles/skillset – Interviewing, Deduction and Investigation skills with subject matter expertise on Clinical Investigator site and GCP document audits with ability to train others
  • Clinical Documentation (e.g. Investigator’s Brochures, Clinical Study Reports, eCTD Module 2 documents for regulatory submissions, etc.)
  • ICHE6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and familiarity with 21 CFR Part 11 and international equivalents, best practices, and industry standards
  • Event Management process and requirements, including investigation, root cause analysis, CAPA plan development and effectiveness checks
  • Change Management principles and process
  • Communication, Influencing, Presentation and Facilitation skills at all organizational levels
  • M.S. (or equivalent degree) and 5+ years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 8+ years of relevant work experience, or relevant comparable background

 

JOB ID# 227173

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Start Date
ASAP
Location
Northeast

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