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Sr. Manager,Regulatory Compliance Initiative

Company: Renaissance LLC
Location: Lakewood
Posted on: November 18, 2020

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Overview

The Sr. Manager, RCI is part of the site Compliance team and reports directly to the site Quality Head of Renaissance. Position will provide compliance leadership and direction to operations and quality, engage in Health Authority Inspections and implement programs designed to proactively drive the site to consistently higher compliance levels. As training is integral to the execution of responsibilities, the individual will lead and direct the training department. Individual will play an active role in Quality Management Review and present issues to Executive management team.

Responsibilities

  • Author and/or review systems, standards and procedures; ensuring compliance with international regulatory expectations.
  • Active role during Inspections to ensure successful outcomes.
  • Assists with identifying appropriate Corrective and Preventative Action Plan (CAPA) to address gaps identified during audits and Inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Confirm effectiveness of CAPA following implementation to prevent recurrence.
  • Implements effective processes to improve and then maintain site quality index metric. Design and implement programs to improve the site compliance levels
  • Monitor and analyze the outcomes of audits and Inspections to identify, investigate, and resolve trends. Report results to Executive team and Quality Councils.
  • Lead and direct activities of the training department
  • Actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc. Well versed in guidances pertaining to the pharma industry.
  • Proactively identify and resolve site compliance shifts and gaps and communicate industry/regulatory compliance updates, changes and initiatives.

    Qualifications

    Bachelor's degree in Science is required, Master's degree preferred, along with substantial experience and a proven record of achievement. A minimum of 10 years of experience in the pharmaceutical industry is required, including auditing, health authority inspection management and risk assessment strategies.

Keywords: Renaissance LLC, Lakewood , Sr. Manager,Regulatory Compliance Initiative, Executive , Lakewood, New Jersey

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