· Job facts
Uses system and technical expertise as well as high process knowledge to manage complex statistical data analysis and root cause investigation. Duties are varied and complex, often involving research, analysis, and solution development. Evaluates and elevates issues when necessary. Provides direction on issues in area of expertise and assists department leadership in setting strategic direction.
Provides a consulting role in the development of new or revised systems to improve business unit regulatory compliance and/or business methods. Accomplishes formative internal assessments to determine compliance level of the organization to regulations and standards and to develop systematic methods to resolve any deficiencies.
Key Roles & Responsibilities
· Evaluates product issues to assure compliance with all federal, global, local and organizational requirements in an efficient and effective manner by working with appropriate personnel, utilizing technical competencies and adhering to applicable quality system procedures and regulations.
· Ensures effective implementation of regulatory compliance activities. Analyzes and reconciles customer data and develops reports in order to effectively communicate progress to the FDA and obtain timely closure of all actions.
· Participates in meetings, recording the results of the process and assuring the completion of required action items, or the referral of these items to the business unit CAPA system.
· Plans, develops, and implements improvements and changes on internal processes to increase efficiency and improve compliance.
· Assists leadership and other specialist in developing and analyzing specific data for projects or investigations.
· Provides technical direction and problem resolution for non-routine issues in Complaint Handling processes.
· Performs assessment and review of cases prior to closure to confirm the complaint file is complete.
· Acts as liaison with other departments on shared processes.
· Bachelor's degree in Science, Engineering, Computer Systems, Statistics, or equivalent experience.
· 2+ years of related experience
· Knowledge of overall Regulatory requirements, Complaint Handling processes, and procedural requirements
· Strong leadership, influence, conflict management, negotiation, and communication skills
· Proficiency with MS Office.
· Ability to work independently, multi-task, and adjust rapidly to new priorities without sacrificing more routine priorities
· Ability to be proactive in finding, resolving and preventing new issues found in data or departmental processes
· Excellent organizational, analytical, and data processing skills
This position is based in Indianapolis, IN. Qualified candidates must currently reside within a 50-mile radius of Indianapolis.
Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance
· Who we are
At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.