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Job

Director, GCP Quality Assurance

  • Location

    Greater Boston Area

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Olivia Gonzalez

  • Contact email:

    o.gonzalez@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    18 days ago

  • Expiry date:

    2019-03-06

Responsibilities:

  • Lead audits, management of GCP Quality Investigations, and regulatory agency inspections
  • Responsible for the ownership of Inspection Readiness Program for GCP including readiness activities, acting as the host of inspections and partnering with Internal GCP Quality Systems for inspection management and follow-up
  • Responsible for the development of global GCP auditing procedures and processes
  • Evaluate audit findings for trends and evaluates corrective action recommendations
  • Provide quality and compliance direction, advice and support to cross-functional areas
  • Advise on compliance risks and necessary CAPAs
  • Set QA compliance objectives in alignment with business objectives and ensure that targets are achieved
  • Foster strong collaborations to drive systematic quality improvements and to provide strategic direction for the continuous improvement of the GCP domain

 

Qualifications:

  • Minimum BS, master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field
  • 10+ years current work experience in pharmaceutical industry Quality Assurance required
  • 10+ years of experience working in either a clinical compliance or Quality group
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
  • Demonstrated Issue Management and CAPA experience in a clinical environment
  • Demonstrated skills in taking initiative and working independently
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
  • Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
  • Ability to effectively manage multiple priorities with a sense of urgency
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations in addition to attention to detail and accuracy of work
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams, willing collaborator
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
 
If you are interested in applying for this or similar roles, please contact Olivia Gonzalez at o.gonzalez@hamlynwilliams.com.