Emerging and Changing Regulations Contractor
Newark Metro Area, NJ
Identify and implement best demonstrated quality and compliance practices and systems across multiple sites:
o Develop and implement global processes and systems;
o Work cross functionally to deploy throughout the organization;
o Ensure continuous improvement of quality systems.
Manage global Emerging and Changing GMP/GDP Regulation and Guidance process:
o Monitor emerging and changing GMP/GDP regulation and guidance documents for evaluation and comment;
o Manage evaluation documentation, comment documentation, and report completion.
Monitor regulatory intelligence including external observation trends.
Carry out plans and actions to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities as assigned.
Must have expert GMP, Quality, and in-depth risk management knowledge;
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy;
Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function;
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams;
Must have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles;
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity;
Completes routine tasks with no supervision; Confident in making non-routine decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;
Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts;
Manages conflict and issues with internal and external customers. Able to recognize conflict and notify management with proposed recommendations for resolution;
Builds and leverages relationships and provides advice internally within function and with global cross-functional teams. Negotiates solutions cross functionally;
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable;
Bachelors of Science;
7-8 years of Pharmaceutical Experience;
Experience with PC based office computers and standard Microsoft Office applications;
Experience with SharePoint;
Experience with electronic document and data management systems.