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 entities to assess compliance with regulatory and Celgene requirements, identify compliance risks and drive concurrence regarding their severity. Contributes to planning and operational analyses for discipline. Establishes and maintains processes and SOPs for GMP/GDP audit function within the Americas region.
Responsibilities include, but are not limited to, the following:
• Independently plan/lead/participate/report on internal/external GMP/GDP audits of Celgene and its Contracted Partners, identifying GMP/GLP compliance gaps or risks.
• Conduct opening meeting with the auditee, SMEs and Celgene audit team
• Perform tasks and work to achieve company goals and organizational objectives
• Lead the grading of observations and the identification of observation and effectiveness check requirements, collate and edit the draft audit report
• Review and track all observation responses and observation actions that result from an audit
• Provide front room/back room support during HA inspections as necessary
• Establish and maintain audit procedures (SOPs, Standards) for the Americas region
• Serve as a subject matter expert within the GMP discipline.
• Contribute to departmental efforts to analyze internal metrics, identify and characterize issues, determine root causes, and plan improvement activites
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Assist in the development of the annual audit plan (where applicable)
• Leads audit team of the Americas region (1 direct report)
• Member of Commercial Americas Quality Leadership team
• Strong/deep knowledge of core auditing processes
• Broad knowledge of all relevant laws/regulations and deeper knowledge of laws/regulations in multiple GMP/GDP area(s); ability to translate regulations into operational requirements
• Basic knowledge in global GLP Regulations and guidance's.
• Detailed oriented, excellent written, oral communication, organization, training and coaching skills
• Minimum of B.S. or equivalent combination of education or professional experience
• Eight years of relevant GMP pharmaceutical/biotechnology industry experience, including at least five years of compliance-related auditing experience
Position is relocation eligible.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.