PQV Trending & Monitoring Analyst 4

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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Job Description:

Johnson & Johnson is currently recruiting for a PQV Trending & Monitoring Analyst 4! This position can be located at any J&J Innovative Medicine site.

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-083217
EMEA Requisition#
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Position Summary:

The PQV Trending and Insight Analyst 4 performs and leads activities associated with trend analyses signal detection complaint data analysis metrics and insights within the Product Quality Vigilance organization. This role supports the development and implementation of quality product-specific surveillance strategies through proactive customer-focused detection and evaluation of potential signals from emerging trends in complaint data.

The position serves as a key interface with product quality owners quality integrators manufacturing sites clinical product value-stream medical safety quality systems and other business partners to ensure awareness assessment and appropriate escalation of complaint signals. The Analyst applies technical statistical product and process knowledge to transform raw complaint and product data into meaningful insights that support risk-based decision-making quality improvement regulatory readiness and complaint vigilance governance.

The PQV Trending Analyst supports individual complaint investigation review utilizing global visibility to support and coach local sites and will use this vantage point to lead improvement projects.

Key Responsibilities:

• Lead conduct and support complaint trending signal detection and data analysis activities for product quality complaints across global products and manufacturing sites.
• Evaluate complaint information from a technical product process and data perspective to ensure appropriate trend analysis signal evaluation investigation linkage and documentation are completed prior to escalation closure or governance review.
• Act as a PQV point of contact for manufacturing sites and cross-functional business partners on trend insights signal awareness aging or coming-due signal assessments prioritization data quality and complaint analysis needs.
• Provide guidance coaching and support to internal and external business partners on complaint trending expectations data interpretation report outputs and related quality system requirements.
• Support regulatory inspections audits health authority requests Complaint Vigilance Review Board discussions business partner requests and senior management reviews by preparing clear data outputs analyses explanations and recommendations.
• Execute transactional tasks to support the complaint management process (data collection/ review complaint record review etc)
• Lead global cross functional improvement projects.

Qualifications:

Education:

• Bachelors degree in a technical scientific engineering statistics microbiology data analytics quality or related discipline is required; equivalent experience may be considered where applicable.
• Masters degree MBA or advanced degree in a technical scientific engineering statistics quality business analytics or related discipline is desirable.
• Green Belt Six Sigma CQE formal investigation training data analytics certification or equivalent quality/process improvement certification is preferred.

Skills & Capabilities:

• Minimum of 5 years of related experience including experience working in pharmaceutical consumer medical device quality assurance quality control complaint management post-market vigilance risk management compliance or another highly regulated industry.
• Advanced knowledge and proficiency in Microsoft Excel for data analysis and signal detection including macros tables lookups and related analytical functions.
• Experience with signal detection complaint trending product quality monitoring or data-driven quality surveillance activities is preferred.
• Experience working with large datasets complaint systems quality systems data processes dashboards or technical reporting is preferred.
• Working knowledge of complaint handling quality system regulations and regulated industry expectations including applicable GMP GDP GVP medical device pharmaceutical and combination product requirements is preferred.
• Demonstrated ability to communicate effectively verbally and in writing including technical writing data storytelling persuasive communication and presentations to multiple organizational levels.
• Global mindset with demonstrated ability to lead change initiatives manage projects develop strong relationships influence without authority and work independently in a cross-functional environment.

Competencies & Leadership Behaviors:

• Assumes personal ownership and accountability for business results while balancing compliance risk innovation and customer value.
• Uses sound judgment analytical thinking and data-driven decision-making to identify issues evaluate risk and recommend practical solutions.
• Seeks to understand emerging trends technologies analytical methods and quality system needs then applies those insights to improve processes and outcomes.
• Works independently challenges the status quo appropriately and continues to move work forward in the face of ambiguity or uncertainty.
• Builds trusted partnerships across functions regions and levels through clear communication collaboration and credible technical expertise.

Other:

• Language Requirements: English required; multilingual capability is an asset.
• Travel Requirements: This position may require up to 05% travel domestically and internationally.
• Environmental Requirements: The incumbent is required to follow all applicable safety procedures to minimize health hazards.
• Physical/Work Requirements: Working at a computer for extended periods of time; ability to work independently in a global team; ability to attend virtual meetings during off-business hours and work outside normal working hours when needed.

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 & 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 external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.