Location: Boudry, Neuchatel, Switzerland
Job Category: Quality
Work Location: Route de Perreux 1 2017
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular
1. 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.
2. 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 decisionmaking, 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.
3. DUTIES AND RESPONSIBILITIES
Audit Planning and Schedule Development
- Schedule audit with the audited entities, according to audit schedule.
- Lead preparation meetings with internal stakeholder
- 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.
- 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.
- 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.
- 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 quality management activities as assigned.
4. 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 industry experience.
5. DEFINITIONS AND ABBREVIATIONS
- GMP Good Manufacturing Practice
- GDP Good Distribution Practice
- GTP Good Tissue Practice
- HA Health Authority
- CSP Contract Service Provider
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.