Loading some great jobs for you...




Job Description:


Vertex Pharmaceuticals is looking for a Senior Manager, Quality Oversight to join our quality assurance team as we 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 monitoring/trending of quality and compliance metrics is advantageous.Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone who is not afraid to dive in and help develop this expanding team.
Position may require up to 10% national/international travel.

Key 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
  • Analyzing, reporting and communication of metrics along with proposals for process improvements
  • Responsible for triaging, reviewing and approving Quality Issues and CAPA
  • Provides regulatory compliance support & guidance to cross functional clinical study teams
  • May serve as GCP Quality Management System representative
    • Participates in collaborative review of impacted SOP/WI
    • Reviews and analyzes key Performance Indicator data and trends
    • Analyzes risk and proposes remedial, corrective and /or preventive actions
    • May participate on process improvement initiatives
  • 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
  • Identifies and generates process related metrics- monitors for efficiency
  • Leads/coordinates internal quality improvement initiatives as appropriate

Qualification:

  • 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
  • In-depth knowledge of:
    • 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
PREFERRED QUALIFICATIONS:
  • Proven experience with all phases of clinical trial execution Phase I IV trials
  • Previous experience with validation and change control preferred
  • Previous participation on material review and product complaint boards (or equivalent) preferred
  • Quality Management Systems within GCP discipline
  • Proven experience with quality assurance oversight and metrics management/monitoring in support of proactive quality risk management
  • Ability to provide GCP compliance interpretation, consultation, training and support to study execution team
  • Ability to understand and translate customer needs for innovative and creative approaches to quality management

#LI-KF1

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

Launch your career - Upload your resume now!

Upload your resume

Loading some great jobs for you...