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DATE ADDED: Mon 15/10/2018

GCP Audit Manager (Clinical Site Audits)

Cambridge, USA
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COMPANY: GPS STAFFING

Job Description

GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!

Title: GCP Audit Manager
Job ID: 486
Industry: Biotech/Pharmaceutical
Location: Cambridge, MA
Duration: 6-Month Contract
Pay Rate Range: Depends on Experience (hourly, W2)

Position Summary:
The R&D Audit team is responsible for managing Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Laboratory Practice (GLP) Quality Assurance audits in support of the Research & Development Quality Management System (R&D QMS).

The GCP Audit Manager will be responsible for managing the planning, conduct and reporting of R&D audits to assure adherence to corporate and R&D policies and procedures, internal standards, and compliance with regulatory requirements and guidelines.

Responsible for managing the planning, conduct and reporting of R&D audits to assure adherence to corporate and R&D policies and procedures, internal standards, and compliance with regulatory requirements and guidelines.

Key Responsibilities:

  • Manage the planning, conduct, approval, and close-out of audits performed by contract auditors (note: this role is not responsible to perform audits. No travel required.)
  • Primary responsibility is managing GCP Clinical Investigator Site Audits
  • Manage existing scheduled audits and plan/prepare for Q1/Q2 2019
  • Facilitate pre-audit activities to ensure audit scope is adequate
  • Author Individual Audit Plans
  • Facilitate post-audit debriefs activities
  • Review and approve Audit Reports
  • Ensure deliverables are timely and adequate and meet quality expectations
  • Assist with escalating audit observations that are critical or of significant safety impact
  • Assist with other audit types which may include GCP/GCLP/GLP/GVP Internal Process and External Vendor audits

Skills Required:

  • Excellent communication skills, both verbal and written
  • Excellent project management skills
  • Able to work independently in a cross-functional, multi-cultural team

Years of Experience:

  • 4 + years pharmaceutical or biotechnology drug development experience
  • 4+ years GCP and/or QA or Compliance experience
  • 4+ years of audit or audit management experience

Trade-Off:

  • Would consider someone with less industry experience but strong background in GCP (monitoring/auditing clinical sites)

Additional Qualifiers (nice to have):

  • Additional experience in another discipline (Good Laboratory Practice, Good Pharmacovigilance Practice) helpful.



To Apply:
We will not respond to everyone personally - qualified candidates will be contacted for a screening.
Please submit your resume in a word document.

Company Description
GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from Fortune 500 companies to startups. Our team is committed to Growth, People, and Success!


Role: GCP Audit Manager (Clinical Site Audits)
Job Type:
Location: Cambridge,

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