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Manager, Data Analyst Risk Management

Company: Johnson and Johnson
Location: Titusville
Posted on: June 5, 2024

Job Description:

Janssen Pharmaceutical, part of Johnson & Johnson Family of Companies, is recruiting a Manager, Data Analyst Risk Management. Remote work options may be considered on a case-by-case basis and if approved by the Company.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Manager, Data Analyst Risk Management is a member of the End-to-End Q&C Risk Reduction, Continuous Improvement & Sustainability office who will help manage risk management initiatives and activities defined by leadership. Also, provides the knowledge of regulator and industry trends related to risk management. This role may draft and/or propose changes to SOPs/WIs related to risk management. Keeps management aware of any gaps in risk management planning, creation, and execution. The Manager, identify required updates to indicators and thresholds to ensure meaningful outputs, in alignment with function input (e.g., risk indicators, scoring logic) and additional opportunities to enhance collaboration with functions.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities:

  • Collect data manually from functions and for indicator analysis.
  • Pull indicator data from identified sources, according to defined cadence (until automated solutions are in place)
  • Collate risk register intake form inputs from functions.
  • Conduct analyses to identify top risks for IMQNC monitoring.
  • Conduct analyses of IMQNC indicators to identify potential risks.
  • Refine and prioritize top risks from both indicator analysis and function insights, in collaboration with function SMEs and IMQNC lead.
  • Support dashboards updates with updated analysis outputs
  • Design and report quality risk metrics, risk review results and risk mitigation actions
  • Monitor and ensure current and new QRM regulations, guidelines and industry trends are appropriately implemented into the Quality System (QS).
  • Drive continuous improvement and expansion of IMQNC processes and capabilities.
  • Establishing, implementing, and maintaining a quality risk management program in compliance with ICH Q9.
  • Collaborate with key stakeholders to develop integrated risk-based approaches to collect, standardize, analyze as well as maintain risk-assessments and plans.
  • Support the report development activities that are required of Risk Management, applying sound analysis methods, producing well-structured visual outputs and succinct written reports.
  • Support Quality Risk Management (QRM) continuous improvement initiatives by applying proven risk-based methods to enhance Key Performance Indicators (KPI's) for Risk and provide implementation strategies to operationalize methods.
  • Assist with the identification of potential systemic gaps and develop and propose remediation plans for global and / or cross-divisional implementation. Education:
    • A minimum of Bachelor's degree is required. A Master's degree or higher in (bio)-chemistry, biotechnology, pharmacy, another relevant scientific or business discipline is preferred. Experience and Skills:

      Required:
      • Minimum of 6years of working experience in the quality organization within the biotechnology, pharmaceuticals, or life sciences industry
      • A minimum of 3 yearsof relevant experience in risk management & project management
      • Strong computer skills with Quality Systems
      • Ability to independently lead projects related to risk management.
      • Knowledge of ICH & Regulatory guidance in Risk Management
      • Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
      • Experience in the identification and management of GxP risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.
      • Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.
      • Proven hands-on experience with quality risk management methodologies including FMEA, FTA, PHA, etc. for medicinal and/or combination products; experience with risk management for medical devices is a plus. Preferred:
        • Industry experience supporting GxP remediation activities, including developing compliance and sustainable solutions to audit/inspection findings, QMS trends, etc.
        • Knowledge and experience with ISO 31000 Quality Risk Management, ISO 9001 Quality Management Systems, ICH Q9, data analytics and reporting.
        • Global Experience
        • Process Excellence experience Other:
          • Strong decision making and analysis skills are required.
          • Strong influencing and negotiation skills.
          • This position may require a 20% of domestic and/or international travel. The anticipated base pay range for this position is $99,000 to $170,200. In the Bay Area, the anticipated base pay range for this position is $113,000 to $195,730.

            The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

            Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits:
            • Vacation - up to 120 hours per calendar year
            • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
            • Holiday pay, including Floating Holidays - up to 13 days per calendar year
            • Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

              This job posting is anticipated to close on 2/16/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

              Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

              For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Keywords: Johnson and Johnson, Trenton , Manager, Data Analyst Risk Management, Executive , Titusville, New Jersey

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