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Senior Specialist, GMP Audit

Req #: 17001681
Location: Boudry, NE CH
Job Category: Quality
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Individual Contributor
Travel: No
Other Locations:Switzerland- Boudry

Description

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.

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 GMP/GDP audits of vendors (Contract Service Providers and Material Suppliers) and Internal sites, in order to assess compliance with regulatory and Celgene requirements, to identify Quality Risks and drive concurrence regarding their severity. This position will also perform annual assessment of vendors and participate in projects related to processes for GMP/GDP audit and vendors management. 1.    MAIN RESPONSIBILITIES 1.1.  Audit Planning and Schedule Development: ·         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. 1.2.  Audit preparation: ·         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. ·         Lead pre-audit team meeting; review pre-audit information with the audit team. 1.3.  Audit conduction: ·         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 Head of GMP/GDP Compliance. ·         Organize meetings with Head of QA Operations, other QA functions, Legal, Reg. Affairs and others to discuss critical or major findings and potential impacts. ·         Adheres to the Auditor Code of Conduct in planning and executing audits. 1.4.  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. ·         Provide draft audit report to the Sr. GMP/GDP Auditor, the Celgene audit team and as needed to the Director, GMP/GDP Compliance, for feedback; finalize the report and ensure it is distributed as per Celgene practices. 1.5.  Audit Follow-Up: ·         Review and track all observation responses and observation actions that result from an audit. ·        

1.    Qualifications and skills ·         At least 6 years of experience, including execution of GMP/GDP Audits. ·         Must have advanced GMP, Quality, and risk management knowledge. ·         Must be able to effectively prepare and convey data analysis to management and others within a group with clarity and accuracy. ·         Must have broadening 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. ·         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. ·         Strong knowledge of core auditing processes ·         Broad knowledge of all relevant regulations and deeper knowledge of relevant laws / regulations in GMP/GDP 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 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 ·         Commitment to self-development and ability to stay abreast of internal and external requirements. @#LI-EX #

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