Medical Science Affairs & Product Satisfaction Group Leader

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Quality Assurance
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Job Summary

Conducts technically complex data gathering, review and evaluation for product quality complaints. Demonstrates a strong proficiency in data and analytics and develops tools that will make data analysis, collection, and reporting more efficient. Serves as an in-house subject matter expert in Market Quality Events to include event creation, detail gathering, triage, training of partners and provides guidance for other staff members. Investigates and applies effective solutions to technical problems that directly impact long-term divisional and company goals and objectives. Develops and implements appropriate action plans as needed. Reviews technical procedures and recommends changes or improvements. Manages personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

Responsibilities

•Provides direction and supervision to Senior Coordinators (or other quality exempt and/or nonexempt personnel). Ensures on-going training and development of staff. Develops and reviews operating procedures.            

•Responsible for the U.S. Product Replacement Program (PRP) data collection, review, interpretation and reporting of information relating to the quality of MK product line. Serves as technical leader for advising and providing direction related to both routine & complex special reporting requests from internal partners and potentially external organizations.    

•Serves as a subject matter expert in quality data analysis. Reviews existing reports and data insights, elevates content and report quality and validates data accuracy. Reviews system capabilities to understand how system reports can be automated, and which reports can increase productivity. Provides Historic Product Review data to support New Product Development           

•Serves as the technical project leader for Market Quality Events to include creation, details gathering, filtering to Corporate, Site and International personnel. Provides updates to include inspection approval and inspection results. Coordinates approval of credit requests. Trains international quality partners in Market Quality Events. Provides recommendations for successful events handling.           

•Responsible for US Call Center Operations Product Quality Complaints data and associated activities to include ongoing feedback and training. Conducts technically complex research to develop, evaluate and disseminate product-related technical information. A sound technical background as well as active listening skills and investigative techniques are necessary to correctly assess and resolve problem situations.       

•Serves as subject matter expert in reporting and analyzing of Key Performance Indicators (KPIs) to include External DPPM, CPM, and Top 10 from North America Region. Interfaces with Global Quality Partners and other divisions to identify and address emerging quality issues.

Experience: 5+ years, pharmaceutical

Education: Bachelor/University Degree

Additional Skills & Abilities

•Must possess an advanced knowledge of various systems and analytical measurement tools to track, evaluate and help resolve customer issues and to recommend the changes to the existing tools

•Must possess excellent communication and organizational skills in order to interface with the global personnel, customer and and authorities to effectively convert technical information into layman’s terms.

•Must possess PC and Internet skills to effectively enter information into the Company’s computer systems and to research and analyze data.

•Strong data and analytical skillset

•Experience in tools like Agile and Tableau.

•Interest in IT services and data analytics infrastructure

•Bilingual skills are beneficial.

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