Celgene Senior GCP Auditor - Good Clinical Practice - Phase I‐IV in Summit, New Jersey

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.

Travels approximately 40‐50%, domestic and international

Responsibilities:

  1. 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

  2. Prepares timely well written audit reports and reports observations to auditees, crossfunctional representatives and management

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

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

  5. Appropriately escalates any compliance issues to relevant management personnel

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

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

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

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

  10. 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

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

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

  13. Performs additional responsibilities, as directed by CQA Management

  14. Demonstrates and promotes Celgene values and behaviors during all CQA activities

  15. Travels approximately 40‐50%, domestic and international

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BIO-US PRIORITY

Qualifications

Skills/Knowledge Required:

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

5+ years of auditing and 10+ years 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

Celgene iscommitted to equal opportunity in the terms and conditions of employment forall employees and job applicants without regard to race, color, religion, sex,sexual orientation, age, gender identity or gender expression, national origin,disability or veteran status.

Celgene complieswith all applicable national, state and local laws governing nondiscriminationin employment as well as employment eligibility verification requirements ofthe Immigration and Nationality Act. All applicants must have authorization towork for Celgene in the U.S.

Senior GCP Auditor - Good Clinical Practice - Phase I‐IV

Location: Summit, NJ, US

Job ID: 16001947