The purpose of the Statistics Consultant QA, Medicines Quality Organization (MQO) role is to guide the business to ensure integrity of data, analysis, and systems. The Statistics Consultant QA will focus on the quality of statistical content as it relates to data analysis processes following clinical trial milestones. The Statistics Consultant QA actively consults and develops strategies to mitigate issues associated with clinical trial execution. The Statistics Consultant QA will partner effectively across MQO International and the Statistics, Data and Analytics organizations to achieve positive quality outcomes. The Statistics Consultant QA will also serve as business quality assurance for IT systems and tools in the statistical data analysis process.
Primary Responsibilities:
- Functional and Technical Expertise
- Expert on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Informs and interprets changes in regulations globally, ensuring compliance and inspection readiness.
- Performs on-going risk assessments and evaluation of the quality of data and analysis procedural compliance used in medical research. The goal of these assessments are to identify performance/compliance gaps relative to current regulations, company standards, and internal procedures and recommends robust corrective actions.
- Accountable for the development and implementation of the quality strategy and quality projects for the function.
- Provides input into the design of the medical, safety, and regulatory quality system and leads implementation into the business area(s)
- Works with the business to establish control parameters to understand when systems, validation packages, plans of analysis, or data integrity is at risk.
- Influence Quality Direction
- Leads the direction of quality by integrating within cross-functional teams, Medical Quality Consultants, Medical Quality Representatives, and Process Owners to ensure consistent practices are employed.
- Provides technical input to help influence the direction to ensure quality is built in.
- Works closely with management and functional teams to resolve complex issues. Influences complex regulatory, business or technical issues within a business area and/or function.
- Manages and facilitates audit and inspections and supports audit and inspections in other cross-functional company areas and with external partners. Includes being on the front-line with the regulatory authorities; facilitating and managing cross functional teams.
- Utilizes quality experience to support change management and business transformation in the delivery of the portfolio.
- Problem Solving
- Leverages experience delivering work products, clinical data, and technical capabilities to discern problem, translate issues, and facilitate problem solving. Build CAPA action plans and monitors effectiveness.
- Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the expedited resolution of issues. Escalates issues and manages the interfaces to ensure issues are well researched, understood and resolved.
- Technical Leadership & Decision Making
- Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of data decisions and/or the portfolio.
- Initiates, drives and coordinates quality improvement initiatives.
- Leads, consults and performs root cause analysis.
- Responsible for quality consultation across the portfolio, involves interactions with all levels across the organizations and including groups such as Process Owners, Regulatory Affairs, Privacy, Legal,
- Key resource in the development of new business process and partnerships - developing quality agreements and directing management on key steps required to ensure quality. This would included evaluating (risk assessment or vendor assessment) the partnership (third party or alliance), the program and setting forth the quality direction and approving oversight plans.
- Shares key learning's to drive simplification and replicate best practices - drives quality into the business.
- Customer/External Focus
- Leads the development of quality agreements internally and external parties and alliances. Interacts with regulators, customers or other outside stakeholders on business issues.
- Acts as quality expert consultant to the business and external parties. Builds relationships with internal and external customers and partners.
- Works closely with Process Owners,MQS consultants, Training, Business Process Management and other areas to ensure there is awareness of systematic issues and compliance concerns. Works as part of a cross-functional team to develop effective systems and processes.
- Maintains external focus, exchange with counterparts or competitors and is key member (leader) of external committees (pharma and/or quality).
Minimum Qualification Requirements:
- Bachelors degree in statistics, data science, or comparable experience
- At least 5 years experience in statistics, data sciences, data analysis, and/or quality
- Global perspective and working across functional and geographical boundaries
- Demonstrated understanding of quality management system principles, including policies, procedures and processes
- Demonstrated ability to identify root cause and manage difficult global business/quality issues. Ability to separate critical from non-critical issues
- Thorough knowledge of quality systems applicable to all areas of medical research
- Demonstrated understanding of IT solution development and testing requirements
- Experience in data analysis, analytics, and presenting data
- Knowledge of the international regulatory framework
- Excellent English language skills written and spoken
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