Senior GCP Auditor - Good Clinical Practice - Phase I-IV - Summit, NJ | Biospace
Get Our FREE Industry eNewsletter

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


Summit, NJ
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


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


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


BIO-US PRIORITY                                  



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 is
committed to equal opportunity in the terms and conditions of employment for
all 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 complies
with all applicable national, state and local laws governing nondiscrimination
in employment as well as employment eligibility verification requirements of
the Immigration and Nationality Act. All applicants must have authorization to
work for Celgene in the U.S.