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Director, Clinical Quality Management

Req #: 1700644
Location: Berkeley Heights, NJ US
Job Category: Medical
Work Location: 400 Connell Dr BERKELEY-400 7922
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Berkeley Heights- 400

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.

The individual in this position supports functional process owners in the identification and assessment of risks to clinical trial quality and development and maintenance of standards, procedures, audit/inspection responses and business requirements/configurations that support continuous improvement of all processes/systems that are a risk to clinical trial quality.  He/she will be responsible to develop a Quality Oversight Plan that supports identification and remediation of process gaps, assessment of ongoing issues (trends) and prospective quality checks.  He/she will lead a Quality Oversight Forum in review of quality metrics, identification of process improvements needed to reduce risks to quality and CAPAs related to sponsor responsibilities in ICH E6.
Prior experience with GCP auditing and leading or participating in regulatory inspections is required.  Knowledge in risk assessment, root cause analysis and prospective indicators of quality issues is desired.
This position reports directly to the Senior Director, Clinical Quality Management.

Key Responsibilities:

  • Support cross-functional colleagues in the development of responses for internal system audits and regulatory inspections that address identification of actual root cause and improvements needed to support preventing finding in future
  • Lead a group of process and system owners in reviewing quality oversight data related to critical processes to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality
  • Work with cross-functional leadership to develop, prioritize and implement plans based on the prospective data to reduce/mitigate risk to clinical trial quality
  • Participate in and/or lead forums and process improvement/system initiatives related to critical to quality processes within the Sponsor Responsibilities such as essential document management, data management, trial management, investigational product management, etc.
  • Partner with process owners to identify process controls needed that enable assessment of impact by all owners, appropriate training is prepared for individuals with roles and effective measures are in place to help monitor process adequacy and compliance

Qualifications:

  • Minimum 10 years in the pharmaceutical or biotech industry and at least 3 years of direct experience in GCP auditing and inspections and 5 years in Clinical Development or Operations managing or supporting clinical trials
  • Minimum 3 years of direct experience with developing business procedures and/or systems that support clinical trials 
  • Strong communication and presentation skills and experience working in a global role required
  • Prior experience in root cause analysis, risk assessment, and prospective indicators of quality issues is desired but not mandatory.

#POST-LI

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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