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Specialist, Vendor Audits (Southwest)

Employer
Celgene
Location
Dallas, Texas, United States
Start date
Sep 17, 2019

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Req #: 1902789
Location: Dallas, Texas, United States
Job Category: Quality
Work Location: Quadrangle Tower - 2828 Routh St Suite 650 75201
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

PURPOSE AND SCOPE OF POSITION:
Lead GMP/GDP/GTP audits of vendors (Contract Service Providers, Material Suppliers and Apheresis Collection Centers), in order to assess compliance with regulatory and Celgene requirements, to identify Quality Risks and drive concurrence regarding their severity. Participate in annual assessment of vendors and projects related to processes for GMP/GDP/GTP audit and vendor management.

This is a remote-based position to be located near a major airport hub in order to carry out audit duties, responsibilities, and travel requirements.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
  • Must have good GMP, Quality, and risk management knowledge.
  • Must be able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Must have broad technical and scientific knowledge.
  • Understands fundamental scientific problems.
  • Must be able to write and review reports with clarity and brevity. Must be able to produce data reports with precision. Must be action-oriented and customer-focused and skilled in decision making, building relationships, problem identification/solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity
  • Good knowledge of all relevant regulations and deeper knowledge of relevant laws / regulations in GMP/GDP/GTP area(s); ability to translate regulations into operational requirements.
  • Good knowledge of all relevant Company policies / procedures / standards with deeper knowledge of Company policies / procedures / standards in GMP/GDP/GTP area(s). • Good knowledge of assigned Celgene business units, processes, management systems, products, services, and technologies
  • Organization and planning abilities with attention to detail.
  • 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.
  • Considers and incorporates global perspectives and requirements.
  • Effective written and verbal communications.
  • Drives execution.
  • Engagement planning and management toward timely and quality completion of objectives
  • Defines plan for audit conduct and determines seriousness of findings and risks; determines if and when to escalate risk or other aspects of audit to management.
  • Training and coaching skills.
  • Healthy skepticism.
  • Commitment to self-development and ability to stay abreast of internal and external requirements.
DUTIES AND RESPONSIBILITIES

Audit Planning and Schedule Development
  • Schedule audit with the audited entities, according to audit schedule.
  • Lead preparation meetings with internal stakeholder

    Audit Preparation
  • In collaboration with management, define the scope and depth of the draft audit agenda.
  • 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 and escalate issues where appropriate.
  • 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 or participate in 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 or participate in 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 Head of GMP/GDP Compliance.
  • Adhere to the Auditor Code of Conduct in planning and executing audits.

    Audit Reporting
  • In collaboration with management, 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.
  • Provide draft audit report to the management and the audit team, for feedback; finalize the report and distribute per procedures.

    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 Audit Certification and Audit Closure documentation.
  • Review timeline extension requests for observation actions 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.

    Compliance, Standards, and Training
  • Support establishing and maintaining audit procedures (SOP's, Standards) under the direction of the Associate Director GMP/GDP/GTP Audits.
  • Contribute to the delivery of training in areas of specialization.
  • Manage performance of audit team during audit engagements.
  • Work collaboratively with other auditors to ensure consistency in auditing process.

    Continuous Improvement and Project Management
  • Contribute to projects regarding Audit and Vendors Management improvement initiatives.
  • 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 KPIs

    Other Responsibilities
  • Other quality management activities as assigned.

EDUCATION AND EXPERIENCE (As Applicable)
  • Minimum of B.S. or the equivalent combination of relevant education or professional experience.
  • Minimum of five years of relevant GMP/GDP pharmaceutical/biotechnology auditing experience.
  • Ability to travel upwards of 70% within the Continental United States and Canada is required.
  • Ability to be based in the Southwest United States Region is preferred, but not required.

DEFINITIONS AND ABBREVIATIONS
  • GMP Good Manufacturing Practice
  • GDP Good Distribution Practice
  • GTP Good Tissue Practice
  • HA Health Authority
  • CSP Contract Service Provider

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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Company

At Celgene Corporation, we’re committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. As a global leader in biotechnology and CAR T cell therapy, Celgene is a place where employees can make a real impact on the lives of patients with unmet medical needs in cancer and inflammatory diseases.

As we rapidly advance our next wave of innovative medicines, we announce the creation of a new global Clinical Development Organization to accelerate and optimize clinical development across our entire mid- to late-stage portfolio. Our commitments in this area will further establish the function as a center of excellence and enhance our strategic leadership in discovery, development and commercialization.

Recognized by Forbes in 2018 as a Top 10 World’s Best Employer and by Business Insider as the #3 Most Reputable Pharma Company in the World, Celgene offers a unique work environment where you can help build the business, while building your career in ways you may not have thought possible. We’re looking for innovative self-starters who want to improve the lives of patients worldwide. For more information, visit https://www.celgene.com/careers/.

Company info
Website
Phone
908-673-9000
Location
Corporate Headquarters
86 Morris Avenue
Summit
New Jersey
07901
US

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