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Audit Manager/ Risk and Security Analyst IV

Company:
Artech Information Systems
Location:
Cambridge, Massachusetts, United States
Posted:
November 12, 2018

Description:

Job Description:

Job Title: Audit Manager/ Risk and Security Analyst IV

Job ID: BIOBJP00000486

Location: Cambridge, MA

Duration: 6 Months

Job Summary

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

• 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 client 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, client 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:

• 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)

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

Additional Qualifiers (nice to have):

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