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Sr. Manager, CQA, Audits & Inspections

Req #: 1700836
Location: Summit, NJ US
Job Category: Quality
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

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.

Summary
As a key member of the CQA Audit and Inspection team, this position is responsible for leadership, planning, conduct, and reporting of GCP audits in order to ensure that clinical trials are conducted in compliance with applicable international regulations, guidelines, and global company standards. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP inspections, and provision of quality oversight and consultation at the clinical study or program team level in support of proactive quality management. This individual actively leverages audit / inspection outcomes / trends to effect improvement in clinical trial quality and compliance with Celgene and global regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of CQA operational processes, systems, tools, and best practices.

Functional Scientific/ Technical Skills

  • Expert knowledge of CQA functions/activities globally
  • Expert knowledge of GCP/ICH and guidelines, regulations and directives
  • Strong knowledge and demonstrated expertise in audit and inspection related activities
  • Excellent oral and written skills and ability to effectively apply these skills
  • Expert in computer/technical skills
  • Expert level cross functional awareness
  • Strong project management skills

Organizational Impact:

  • High global organizational impact and influence
  • Executes and delivers on corporate objectives and drives goals
  • Significant impact on function
  • Provides strategic quality oversight and consultation across multiple studies
  • Acts as mentor for CQA colleagues and stakeholder departments; mentors Associate Manager and Manager levels
  • Maintains awareness of and proactively anticipates potential issues related to quality, safety, efficacy for assigned studies or program/indication and provides input to study team of possible GCP impact—escalating and proposing solutions to CQA program leads as appropriate.

Level of Independance:

  • Fully independent
  • Leads complex, large, global projects and initiatives
  • Sets individual priorities

Creativity and problem solving:

  • Demonstrates excellent critical thinking skills and judgement
  • Source of innovative solutions
  • Strategic input to management and functional areas
  • Raises issues and implements action plans
  • Escalates issues and presents solutions to senior management
  • Identifies interdependencies and links for proactive problem solving
  • Leads team members
  • Has ability to solve multiple problems with varying degrees of complexity for CQA and stakeholder functions

Teamwork:

  • Driver and motivator in challenging times for CQA activities
  • Leads, develops and implements initiatives and best practices
  • Maintains/promotes a global focus
  • Coach and mentor for team
  • Models positive team behaviors in CQA and cross-functional settings
  • Influences key stakeholders outside of the team and leverages established relationships / networks

Education and Experience:

  • BA / BS or equivalent experience
  • Degree in relevant discipline
  • Minimum 5-7 years clinical quality assurance auditing
  • 7-10 years overall relevant experience including global experience

#LI-POST

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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