Sr. Auditor, GMP Job
Celgene - Berkeley Heights, NJ

This job posting is no longer available on Healthcare Jobs on Display. Find similar jobs: Senior Auditor jobs - Celgene jobs

Job Title:
Job ID: 13755
Location: Berkeley Heights, NJ - 400

Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Gbl GxP Audit&Health Auth Insp - 1109

About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Sr. Auditor GMP

Prerequisites:
  • Completed BS degree in science, engineering, or related discipline required
  • Must have at least seven (7) years of relevant GMP pharmaceutical/biotechnology industry experience
  • At least four (4) years of Compliance-related auditing experience required. At minimum one of the four (4) years requires Compliance-related auditing experience at companies that manufacture sterile or cell-based products
  • Experience as Lead Auditor required
  • Strong and deep knowledge of core auditing processes required
  • Broad knowledge of all relevant laws / regulations and deeper knowledge or relevant laws / regulations in multiple GxP area(s) required, with the ability to translate regulations into operational requirements
  • Health authority inspection experience is a strong plus
Summary/Scope:
  • Lead audits of assigned entities to assess compliance with regulatory and Celgene requirements; identify compliance risks and drive concurrence regarding their severity
  • Contribute to planning and operational analyses for discipline
Core Responsibilities:
Strategic Corporate Audit Leadership

  • Lead discipline specific mock inspections to prepare sites for H-A Inspections
Audit Planning and Schedule Development

  • Provide input to the risk assessment of assigned auditable entities to identify the risk based audit frequency for each entity
  • Identify new risks that may not be accounted for in the risk assessment template and communicate to Audit Lead and/or Director / Discipline Lead
Audit Preparation

  • Review auditee’s audit history and other supporting information; provide to audit team members for use in preparation activities
  • Meet with the business, audit team and SMEs to refine the risk assessment, ensure all risks are identified, and finalize the audit agenda
  • Issue audit agenda; request required pre-audit information from the auditee
  • Ensure that the audit owner and potential observation owners are identified; lead resolution of issues regarding identification of owners
  • Resolve schedule issues
  • Lead pre-audit team meeting; review pre-audit information with the audit team
Audit Conduct

  • Conduct opening meeting with the auditee, auditee SMEs and Celgene audit team, including Celgene SMEs, to review the agenda and confirm agreement on scope and timelines
  • Lead the execution and conduct of the audit
  • Ensure the audit team uses relevant audit guidelines and that the team executes the defined audit agenda
  • Lead all Celgene audit team/SME meetings and joint auditee/Celgene audit team meetings that occur during and at end of the audit; verify audit observations with auditees
  • Ensure that findings and observations are identified, evidence is collected where possible, all potential critical observations are immediately identified, and auditee expectations and next steps are identified
  • Escalate potentially critical observations to the Audit Lead and/or Director / Discipline Lead and to the Sr. Director / Regional Lead of Corporate GxP Audits. Meet with both to review the observation and decide next steps.
  • Attend meetings with CCO, Legal, Regulatory Affairs (and possibly others) to discuss findings, potential impacts
Audit Reporting

  • Lead the grading of observations and the identification of observation and effectiveness check requirements, ensuring that differences in opinion are resolved
  • Collate and edit the draft audit report
  • Review draft audit report with the auditee if an internal audit; provide draft audit report to the Audit Lead and/or Director / Discipline Lead and to the Sr. Director / Regional Lead of Corporate GxP Audits, as needed, for feedback; negotiate revisions; finalize the report and ensure it is distributed as per Celgene practices
Audit Follow-Up

  • Review and track all observation responses and observation actions that result from an audit
  • Determine if observation responses are complete and if not, negotiate with observation owner(s)
  • Review evidence to determine if it is acceptable and negotiate revised dates with the observation or action owner(s) if needed. Escalate all overdue and unacceptable responses Determine when an observation can be closed; issue Observation Responses Complete and Audit Complete certificates
  • Review timeline extension requests to determine if justification and new due date are acceptable; reject unacceptable requests. Communicate decision and rationale to observation or action owner. Ensure that the subject of the extension request is updated with new date
Health Authority Inspections

  • Provide front-room/back-room support during H-A Inspections as necessary
Compliance, Standards, and Training

  • Contribute to the delivery of training in areas of specialization
  • Manage performance of audit team during audit engagements.
  • Provide input to performance management and development planning for auditors
  • Contribute to the development of the procedure for auditor qualification
  • Work collaboratively with Sr. Director / Regional and Director / Discipline Leads to ensure that appropriate training is developed, deployed, and monitored within the overall Department
Continuous Improvement and Project Management

  • Contribute to the internal Departmental efforts to analyze internal metrics, identify and characterize issues, determine root causes, and plan improvement activities
  • Contribute to the review and analyses of Celgene’s compliance KPIs
Regulatory Intelligence Support

  • Support collaborative efforts (with Sr. Director / Regional Leads, Director / Discipline Leads, Lead Auditors) to consolidate research and assess implications of emerging regulations, guidances, and industry standards
Key Requirements and Knowledge:
  • Completed BS degree in science, engineering, or related discipline required
  • Must have at least seven (7) years of relevant GMP pharmaceutical/biotechnology industry experience
  • At least four (4) years of Compliance-related auditing experience required. At minimum one of the four (4) years requires Compliance-related auditing experience at companies that manufacture sterile or cell-based products
  • Experience as Lead Auditor required
  • Strong and deep knowledge of core auditing processes required
  • Broad knowledge of all relevant laws / regulations and deeper knowledge or relevant laws / regulations in multiple GxP area(s) required, with the ability to translate regulations into operational requirements
  • Broad knowledge of all relevant Company policies / procedures / standards with deeper knowledge of Company policies / procedures / standards in multiple GxP area(s)
  • Strong and deep knowledge of assigned Celgene business units, processes, management systems, products, services, and technologies
  • Health authority inspection experience is a strong plus
Required Competencies and Skills:
  • Organization and planning abilities with attention to detail
  • Problem identification and analysis skills
  • Basic understanding of risk management and ability to evaluate an organization’s risk exposure
  • Proficient in Microsoft Office and other standard applications
  • Good understanding of business functions and internal controls to assess compliance in auditee organizations where clear standards and procedures do not exist
  • Training and coaching skills
  • Willingness and ability to identify and investigate areas of potential risk; healthy skepticism
  • Commitment to self-development and ability to stay abreast of internal and external requirements
  • Independent thinking
Equal Employment Opportunity

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.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Healthcare Jobs on Display - 17 months ago - save job - block
Recommended Jobs
Senior Quality Compliance Specialist
Elkton, MD Manufacturing plant - Somerset, NJ
Terumo Medical Corporation - 10 days ago

Associate Vice President, Quality Assurance
Ferring Pharmaceuticals, Inc. - Parsippany, NJ
Ferring Pharmaceuticals, Inc. - 30+ days ago

QA Senior Specialist, Audit Lifecycle Managem...
International AIDS Vaccine Initiative - New York, NY
International AIDS Vaccine Initiative - 30+ days ago
About this company
41 reviews
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.