Celgene Senior Specialist, GMP/GDP Audits in BOUDRY, NebraskaSwitzerland
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.
This position will be responsible for leading audits of assigned vendors (Contract Service Providers and Material Suppliers) within the International Region, in order to assess compliance with regulatory and Celgene requirements, to identify external Quality Risks and drive concurrence regarding their severity.
This position will also participate to projects related to processes and SOP’s for GMP/GDP audit and vendors management within the International region.
Main responsibilities :
In collaboration with Sr. GMP/GDP Auditor, define the scope and depth of the draft audit agenda
Lead preparation meetings with internal stakeholders
Schedule audit with the audited entities, according to Quarterly Audit schedule
Conduct opening meeting with the auditee
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
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 as per relevant SOPs.
Lead the grading of observations and the identification of observation and effectiveness check requirements, ensuring that differences in opinion are resolved
Collate and finalize the report and ensure it is distributed as per Celgene practices
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 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; Escalate overdue responses.
Health Authority Inspections:
- Provide front-room/back-room support during HA Inspections as necessary.
Compliance, Standards, and Training:
Support establishing and maintaining audit procedures (SOP’s, Standards) for the International region under the direction of the Sr. GMP/GDP Auditor function,
Contribute to the delivery of training in areas of specialization,
Manage performance of audit team during audit engagements,
Work collaboratively with further International QA Operations auditors to ensure consistency in auditing process.
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.
• At least 6 years of experience, including execution of GMP/GDP Audits.
• Strong / deep knowledge of core auditing processes.
• Broad knowledge of all relevant laws / regulations and deeper knowledge or relevant laws / regulations in multiple GMP/GDP area(s); ability to translate regulations into operational requirements.
• Organization and planning abilities with attention to detail.
• Problem identification and analysis skills.
• Strong / deep 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 audit 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.
Senior Specialist, GMP/GDP Audits
Location: BOUDRY, NE, CH
Job ID: 17000857