Celgene is committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring to Celgene?
On the Global Quality Systems team, we deliver our mission by….
Leading GMP ( Good Manufacturing Practice )/GDP ( Good Distribution Practice )/GTP ( Good Tissue Practice) audits of vendors (Contract Service Providers and 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 the annual assessment of vendors and projects related to processes for GMP/GDP/GTP audit and vendor management.
As the Senior Specialist GMP/GDP Audits, you’ll support that goal by….
Audit Planning and Scheduling Development
• Scheduling audit with the audited entities, according to Quarterly Audit schedule.
• Leading preparation meetings with internal stakeholders.
Preparing Audit
• 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.
Conducting Audit
• 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.
Reporting Audit
• 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.
Health Authority Inspections
• Provide front-room/back-room support during Health Authority Inspections as necessary.
Compliance, Standards, and Training
• Support establishing and maintaining audit procedures (SOP’s, Standards) under the direction of the Manager GMP/GDP 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.
Education and Experience:
• 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, including at least two years of Compliance related auditing experience.
• Broad GMP, Quality, and risk management knowledge.
• Able to effectively prepare and convey data analysis to management and others within a group with clarity and accuracy.
• Broad technical and scientific knowledge. Must be able to analyze complex data in areas specific to job function at an advanced level.
• Must have strong authorship and be able to critically review reports to address relevant technical or scientific issues. Must be able to produce data reports with a high level of precision.
• 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.
• Strong knowledge of core auditing processes.
• 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.
• Broad knowledge of all relevant Company policies/procedures/standards with deeper knowledge of Company policies /procedures /standards in GMP/GDP/GTP area(s).
• Strong 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.