Celgene Senior GCP Auditor - Switzerland in BOUDRY, NebraskaSwitzerland

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Role and Responsibilities

  • Performs and reports assigned GCP audits of (Phase I‐IV) CRD studies, including but not limited to Clinical investigator sites, Vendors/CROs, internal system/processes and Clinical documents or data

  • Prepares timely well written audit reports and reports observations to auditees, cross-functional representatives and management

  • Obtains and evaluates audit responses/corrective action plans (CAP) and conducts follow up, as needed

  • Performs ad‐hoc for‐cause audits, as needed, to identify or confirm or suspected noncompliance and assist with root cause identification

  • Appropriately escalates any compliance issues to relevant management personnel

  • Leads/assists Health Authority inspection management team in preparation for and during inspections

  • Evaluates GCP related issues to assess prioritization and work towards risk mitigation and appropriate resolution

  • Evaluates aggregate audit observations and trends in order to develop periodic compliance/metric reports and tracking, as requested

  • Responsible for training/orientation of newly hired CQA auditors and participate in GCP training program of Affiliates and/or other Celgene groups

  • Maintains high degree of knowledge of global industry expectations, GCP regulations and provides GCP expert advice/guidance to CRD staff in support of GCP operations

  • Acts as the CQA Study Team (ST) representative for assigned studies and actively participates in ST meetings

  • Participates in CQA compliance special projects, process improvement, or other investigations, and reports results to management

  • Performs additional responsibilities, as directed by CQA Management

  • Demonstrates and promotes Celgene values and behaviors during all CQA activities

  • Travels approximately 40‐50%, domestic and international

Qualifications

B.S. or B.S./M.S. in Chemistry, Biology, or related fields

Skills, Knowledge and Experience required

  • Solid auditing experience and good overall diverse experience in the pharmaceutical industry

  • Expert knowledge of applicable global GCP guidelines/regulations

  • Ability to work independently on multiple projects with limited supervision

  • Excellent negotiation skills and ability to influence decision‐making across multiple functions

  • Strong verbal, written, presentation and/or in communication skills

  • Strong organization, problem solving, critical thinking and decision‐making skills

  • Strong interpersonal skills and teamwork

*MONEU

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Senior GCP Auditor - Switzerland

Location: BOUDRY, NE, CH

Job ID: 17001292