Manager/Senior Manager, Quality – GCP, GLP, PV Compliance and Auditing
Aveo Oncology - Cambridge, MA

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The Manager/Senior Manager for GCP, GLP, and Pharmacovigilance Compliance and Auditing will execute the Audit Management Program (GCP, GLP, and Pharmacovigilance)
  • Develop annual audit plans for each impacted function and execute against plans with functional area participation
  • Maintain a living annual audit schedule
  • Work with functional area(s) across quality to prioritize and remediate audit observations
  • Manage supplier/vendor qualifications and re-qualifications
  • Author/approve SOPs for functional area
  • Assist in coaching for regulatory and partner audits
  • Process improvements
  • Budget Management
  • Support as subject matter expert for regulatory and partner audits
  • Participate in due diligence activities for new product acquisitions

Internal GCP, GLP & Pharmacovigilance Compliance:
  • Review and audit clinical/PV/non-clinical source documents and listings
  • Review and audit clinical/PV/non-clinical sections of regulatory filings
  • Collaborate with clinical/PV/GLP non-clinical functions to identify CAPAs, and manage and approve the completion of CAPAs
  • Perform internal process audits and gap assessments
  • Collaborate with clinical/PV/GLP non-clinical functions to implement develop compliance processes and process improvements
External GCP, GLP, & Pharmacovigilance Compliance:
  • Perform vendor qualification and requalification audits and assess responses/CAPAs for adequacy
  • Perform clinical investigator site audits and assess responses/CAPAs for adequacy

Qualifications:
  • Bachelors or Advanced degree in the sciences or other disciplines
  • Minimum of 8 years direct experience in the pharmaceutical industry in combination of
  • quality, pharmacovigilance, clinical, and/or regulatory
  • Track record of conducting both internal and external GCP, GLP and Pharmacovigilance audits and managing their outcomes
  • Experience with working with and qualifying external vendors
  • Proactive and polished communication skills, verbal and written
  • Superb attention to detail
  • Ability to travel 15-20% (domestic and international)

Aveo Oncology - 11 months ago - save job - block
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