Exp Anlst Quality Systems

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As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

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 es and 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.

Essential Job Duties and Responsibilities:

• 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.

• Performs other Quality-related job duties as required.

Qualifications:

• A minimum of a bachelors 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.

• Experience working with electronic Quality Management Systems

• Expert with Microsoft Excel or other business intelligence / analytical tools

Preferred:

• 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.
• May perform other duties as assigned.

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The anticipated base pay range for this position is :

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