Consultant, Compliance and Risk Management, Investigation Material Supply Chain
Newark Metro Area, NJ
Identifies strategic, operational and systemic compliance related issues both internally and externally. Negotiates with and influences stakholders to resolve issues by developing proposals, outlining solutions, and negotiating time commitments and resources affecting efficiency and accuracy within the supply chain.
May lead preparation activities for regulatory inspections, identify potential areas of risk, and develop risk mitigation strategies.
Maintains a strong understanding of global Health Authority regulations for packaging, labeling, systems, distribution, and vendor management.
Creates a learning strategy to educate IMSC and other functions by conducting departmental training on global Health Authority regulations and developing a regulatory training curriculums.
Provide strategic direction on developing, implementing auditing and monitoring tools, processes, and metrics
Identifies and develops corrective actions to fill gaps; using the IMSC Governance Model drives the implementation of corrective actions and assesses the results.
Identifies compliance risks with external departments SOPs and policies that may impact IMSC processes and guidelines.
Maintains a strong understanding of GTMM SOPs and identifies cGCP curriculum requirements for IMSC.
Responsible for alignment of the compliance strategy and new/ revised IMSC procedures and policies.
Exhibit strong communication, collaboration and conflict management skills to establish and maintain relationships with cQA and GTMM in order to facilitate decision making, action and execution.
Solve abstract problems across functional areas of the business. Identify and evaluate fundamental issues for major functional areas through assessment of intangible variables.
Provides IMSC Sr. Management with quarterly review of IMSC compliance and proactively raises areas of concern/risk
Maintains an IMSC compliance program that outlines a strategy to ensure compliance with GXP policies and standards.
Recognized SME with ability to apply knowledge and influence other functions regarding best practices.
10+ yrs experience in the pharmaceutical industry with 7 yrs experience in drug development, clinical supply chain management and/or clinical manufacturing and 3+ years in compliance management
Experience in multiple functional areas (clinical, regulatory, quality) demonstrating a broad understanding of pharmaceutical development.
Advanced knowledge of all phases of drug development, of the functions and processes relevant to drug development.
Advanced knowledge of investigational material supply chain and ability to handle multiple projects simultaneously.
Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
Experience managing change in a dynamic, complex environment
Strong background in cGxPs and ICH requirements
In depth knowledge of clinical trial documentation retention requirements