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

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Job Description:

Johnson & Johnson is currently recruiting for a Product Quality Vigilance Operations Analyst! This position can be located in Horsham or Malvern, PA, Raritan, NJ, Gurabo, PR, Beerse Belgium, Schaffhausen Switzerland, Cork Ireland or Latina, Italy.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

North America- Requisition #R-016619

Beerse Belgium, Schaffhausen Switzerland, Cork Ireland or Latina, Italy - Requisition #R-004014

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130, 000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:

The position predominantly performs activities including trend analyses, signal detection and data analysis in the Product Quality Vigilance (PQV) organization.

This position leads efforts in support of the business as it develops and implements quality product-specific surveillance strategies. Proactive, customer focused systematic detection and evaluation of potential signals from emerging trends in complaint data. This position will be a key interface with the various product and business groups to ensure awareness of signals.

This is a hands-on position that will require an ambitious individual with excellent analytical, written and verbal communication skills. You will have the opportunity to collaborate with business partners at all levels with multiple functional groups in an environment that embraces teamwork and risk-based decision-making

This position has the following responsibilities:

• Partner with various business stakeholder groups (clinical, product quality owners, product value-stream, IM sites) to perform trending analysis signal detection as related to J& J products and complaints
• Dive deep into data but also communicate high-level findings through expert analysis
• Provides support during audits by extracting appropriate complaint data sets and analysis

Key Responsibilities:

SIGNAL DETECTION & ANALYSIS

• Work closely with the business to provide visualizations and other tools to better detect signals as related to products and complaint processes
• Use data visualization, reports and data-driven presentations to present digestible conclusions and recommendations

• Continuously learn and apply emerging technologies and techniques, pushing you and your colleagues to new heights

METRICS, TRENDING & DATA VISUALIZATION

• Compile and analyze data, metrics and trends associated with complaint handling processes.
• Implement tools and develop techniques (technical solutions) for measuring and reporting performance metrics
• Provide support for operational and ad hoc information as well as customized reports for specific audiences.

• Transform raw product and complaint data into useful metrics and visualizations to support analysis

PRODUCT, PROCESS & DATA INTEGRATION

• Ensure complaint system has reliable product information
• Leads and captures data content to support complaint process changes including New Product Introduction that are critical to complaint analysis
• Leads conventions and quality expectations for complaint product data
• Improve compliance and ensure high data quality for analysis

• Ensures good documentation and data governance including appropriate SOPs and work instructions

AUDIT support

• Generates data for audit support, data mining activities and coordinate with system administrator to extract data from module or platform for ad hoc requests and other data requests.

• Act as a translator between business and technical teams, by consulting on the data available or feasibility of acquiring data.

Qualifications / Requirements:

Education:

A minimum of a bachelor’s Degree (or equivalent experience/degree) is required. A focused degree in science, technology, engineering, statistics, microbiology, or related discipline is preferred.

Experience:

• Minimum of 5+ years of related experience, including significant experience working in pharmaceutical, consumer, medical device or other related or highly regulated industry is required
• Advanced knowledge and proficiency of Microsoft Excel (macros, tables, look-ups, etc.) for data analysis/signal detection is required
• Experience with Signal Detection (data trending) activities is preferred
• Proficient using analytics tools such as Excel, Tableau, SQL, Crystal Reports or equivalent is preferred
• Experience with one or more technologies supporting Quality Systems (complaints, other) is a plus
• Experience working with large datasets and/or data processes is a plus

Other:

• Assumes personal ownership and accountability for business results and solutions balancing risk with innovation
• Makes the customer central to all thinking; keeps the focus on driving customer value
• Seeks to understand the latest trends and developments and then looks for ways to capitalize and drive innovation to improve upon them
• Works independently, challenges status quo with ability to press forward in the face of uncertainty.
• This position has an estimated annual salary of $91, 000-$147, 200 USD$
• 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)).
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• 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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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