Data and Risk Mgmt Sr QS Specialist

Senior Quality Systems Specialist – Data Integrity and Risk Management

The Senior Quality Systems Specialist – Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting. Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information. Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules. Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums.

Assists in the implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential risks to the organization. Assesses and improves quality analysis review process to identify control deficiencies, and to ensure the risk management process is operating effectively and efficiently. Leads and conducts complex risk assessments under minimal supervision, leading and ensuring proper execution and utilization of appropriate risk models.

• Responsible for identifying, assessing, controlling and mitigating risks to ensure patient safety and product safety, quality, and regulatory compliance (e.g., ICH Q9) throughout the product lifecycle.
• Provides accountability and ownership of the local site risk register including escalating to the global platform based on risk level. Responsible for ensuring that site level risks are appropriately classified.
• Supports the digitalization and automation of quality risk management data to drive data insights, and process innovation.
• Documents business critical issues and risks following integrated risked-based decision making.
• Leads risk assessment sessions where required and as part of change management.
• Partners with data analytics team(s) and leverages data analytics tools to create dashboards, reports, and any additional ad-hoc requests impacting data integrity and risk management.
• Identification of trends and opportunities for improvements through analysis of complex datasets including monitoring for Systemic Issues and Significant Quality Issues requiring escalation.
• Collaborate cross-functionally to determine and address data and reporting needs.

• A minimum of a bachelor's degree required (preferred: Data Integrity, Risk Management, Computer Science, Engineering Science or equivalent)
• Two or more years of experience mining and assessing data as a data analyst or similar role
• Hands-on experience with executing various risk assessment methodologies, tools and application of risk-based decision-making.
• Quality experience & applied knowledge of cGMPs including 21 CFR part 11 / Annex 11, ICH Q7 and Q9.
• A minimum of (2) years of experience in Quality Assurance within the pharmaceutical / medical device / life sciences and / or other GxP regulated industry.
• Experience using data analytics / visualization tools (e.g., Domo, Tableau, Looker, Qlik, Microsoft Power BI, Python) in data analysis;
  Solid understanding of data structures and transformations.
• Expert with Microsoft Excel or other business intelligence / analytical tools

• Skilled in analytical and critical thinking used in problem solving techniques.
• Strong ability to prioritize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with other team members that may impact timely completion.
• Works effectively with people that have diverse work styles, talents and ideas.
• Excellent communication skills.

Required Skills:

Preferred

Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People

The anticipated base pay range for this position is: $79,000.00 - $

Additional Description for Pay Transparency:
Subject to the terms of their…