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Senior Manager, Clinical Quality Assurance, Quality & Process

Req #: 1800183
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 Clinical Quality Assurance (CQA) Quality and Process team, this position is responsible for leading and/or contributing to identification, development, implementation, management, and enhancement of CQA operational processes, systems, tools, and best practices.  Responsibilities also include leadership/conduct/reporting of GCP audits and preparation/management/follow-up of Health Authority (HA) GCP inspections.  This individual actively leverages audit/inspection outcomes/trends to effect improvement in clinical trial quality and compliance with Celgene and global regulatory requirements.

Responsibilities at any time will include a subset of—however are not limited to--the following to support department priorities/deliverables:

Quality and Process Optimization

  • Pursue/maintain current knowledge of applicable regulations, guidelines, and company standards
  • Lead/assess CQA operational processes, identify/support/implement process improvements to enhance team efficiency/effectiveness
  • Lead/participate in CQA and cross-functional (stakeholder) process-related initiatives/projects and facilitate/support implementation as appropriate
  • Provide GCP compliance consultation to stakeholders on process enhancement/compliance and quality issue management
  • Lead/complete various assignments as directed by CQA Management

Quality Management System

  • Lead/participate in CQA Quality Management System application [eQMS] development, enhancement, implementation, maintenance activities  
  • Initiate/manage/contribute to overall eQMS project planning/oversight and project deliverables; proactively evaluate/mitigate risks in an ongoing manner; keep CQA management apprised of status, risks, and mitigation plans; and escalate critical issues with proposed solutions as appropriate
  • Lead/manage/coordinate development of validation activities and implement change control items including assurance of completeness of required documentation
  • Lead/participate in planning and conduct of CQA and stakeholder eQMS training including development of training materials, delivery of content, and ongoing support
  • Support eQMS end users regarding access problems and/or guidance on utilization and data entry
  • Liaise/collaborate with vendor(s) and Celgene IT to define and manage deliverables

Audit Planning, Conduct, Reporting, and Follow-up

  • Assess/plan and/or perform GCP audits of clinical investigator sites, vendors, internal systems/processes, and clinical documents
  • Review and/or prepare timely well-written audit reports and communicate findings to auditees, cross-functional representatives and management
  • Assess/review audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
  • Review/evaluate and/ or maintain/track CAPAs and follow-up with stakeholders to ensure actions are completed
  • Lead/participate in audit report review team/process to promote consistent delivery of an optimally impactful ‘top quality’ report/product

Quality Metrics and Analysis

  • Lead/provide input to the development of CQA metrics
  • Analyze CQA data from all relevant sources [audits, inspections, etc.] and develop/conduct presentations to stakeholders including trends and areas of potential quality/compliance risk
  • Provide risk identification/mitigation support for potential or identified operational issues
  • Leverage audit/inspection trends and other information sources to support data-driven audit planning and optimize clinical trial quality and compliance via stakeholder education and consultation

Health Authority Inspection Planning, Preparation, Management, and Follow-up

  • Lead/participate in planning/preparation/conduct/follow-up for Health Authority GCP inspections
  • Provide guidance and mentorship to CQA support staff regarding HA inspection-related activities
  • Lead/contribute to HA Inspection dossier preparation and document compilation/QC
  • Lead CQA planning activities with Celgene IT and Facilities Departments to ensure coordination of all inspection logistics, including point of contact, conference rooms, necessary equipment/supplies—liaising with internal/external parties to arrange setup/access to internal and vendor applications for HA inspector(s)
  • Ensure creation/maintenance of documents for pre-inspection preparation as well as inspection mailboxes, document request templates, and file sharing accounts/access
  • Oversee/conduct/coordinate training for defined SMEs and ensure setup of pre-inspection preparation meetings for line unit heads and appropriate staff
  • Manage/oversee Document Tracker during inspections to verify documents requested and documents provided to the Health Authority Inspectors
  • Oversee/participate in consolidation and formatting of final response documents for Site Inspections and Sponsor/Monitor Inspections
  • Lead/collaborate with other CQA team members to complete inspection follow up activities within and outside department as needed
  • Oversee/ensure tracking/maintenance of CQA-managed Health Authority inspection data

Talent Development/Management

  • [As applicable] Provide leadership, coaching, mentoring, and support for team members
  • [As applicable] Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables
  • [As applicable] Contribute to functional talent development and performance management processes for direct reports

Other

  • Travel 10-35%, domestic and internationally, as needed

Skills/Knowledge Required:   [Refer to Core Competencies document for level differentiation]

  • Minimum of BA/BS degree in relevant discipline or equivalent/relevant work experience
  • Minimum of 7 years of work experience in clinical research and/or a GCP-related quality assurance environment [Refer to Core Competencies document]
  • Experience with the development, deployment, and maintenance of Quality Management System technology solutions preferred
  • High degree of computer skills including proficiency with Microsoft Word, Excel, PowerPoint and Outlook are essential and knowledge of other Office applications helpful.
  • Strong organizational and time management skills

  • Ability to prioritize and multi-task successfully in a fast-paced environment
  • Responds flexibly to shifting demands and changing priorities, proactively looking for ways to contribute
  • Demonstrates attention to detail and high quality while meeting deadlines and commitments
  • Collaborates with team members across functions and geographies to get work done while encouraging others to do the same
  • Maintains optimism and composure in times of change, uncertainty, or stress
  • Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members

Demonstrates critical thinking, sound judgement, and initiative to solve problems

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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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