Job Details

Logic Compliance Manager

Company name

Japan Tobacco International USA, Inc

Organization Type

In-House

Job Type

Attorney

Date Last Verified

Jul 06,2018

Posted on

Apr 03,2018

Years of Experience

Min 5 yrs required

Location

Princeton, NJ
Practice Area
Intellectual Property >> Intellectual Property - Patent >> Intellectual Property - Patent - Life Sciences >> Biotechnology
Intellectual Property >> Intellectual Property - Patent >> Intellectual Property - Patent - Life Sciences >> Pharmacology
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Logic Compliance Manager The candidate will ensure that the company complies with federal, state and industry regulations and standards. Will report to the Logic United States (US) Legal Counsel. Stay abreast of all changes in tobacco and related development regulations in the US and abroad, to help guide process changes within our organization. Serve on the Standard Operating Procedure (SOP), Change Management and Incident Response Committees contribute to regular review, updates and testing of existing compliance policies and processes to continue ensuring proactive risk management and expertise for Logic as it grows globally. Manage the company’s compliance with state, federal, and international laws. Review, develop and edit SOPs to ensure they are consistent with corporate objectives and regulatory agency compliance requirements. Manage education and communication of companywide policies. Deliver and oversee internal required employee compliance training, maintain and schedule employee training logs. Responsible for representation during preparation of audits, in collaboration with other Logic departments. Facilitate internal audits including a review of previous regulatory bodies, third party and internal audits to confirm and track implementation of proper corrective action or recommendations. Initiate and follow-through on Logic, JT, and JTI Corrective and Preventative Action (CAPA) programs as required. Responsible for investigations of potential compliance issues in accordance with company policy. Manage key performance indicators (KPIs), tracking compliance, and risk management. Provide compliance reporting and metrics to management based on internal investigations and best practices. Qualify and develop relationships with external vendors to advance business partnerships are aligned to our regulatory process. Work closely with the Legal department to ensure appropriate legal risk management.

Qualification and Experience

The candidate should have Bachelor’s degree or equivalent. Post-graduate degree or law degree is a plus. Proven compliance experience within the tobacco, pharmaceutical, medical device, and/or biotechnology industry preferred; Active participation in regulatory authority audits experience is preferred; Familiarity with 21 Code of Federal Regulations Part 11 systems. Must have proven ability to exercise strong business judgment with a strong understanding of the fundamentals of the tobacco, pharmaceutical, medical device, and/or biotechnology industry. Excellent interpersonal, communication, investigative, presentation and training skill is essential.

Additional info

Job ID: 9204

Company info

Hiring Coordinator
Japan Tobacco International USA, Inc
1, rue de la Gabelle
1211 Geneva 26
Geneva, GENEVE 1211

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