Director, PQV Trending and Insight

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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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 countries that align with your preferred locations:

North America - Requisition Number: R-054770

Europe - Requisition Number: R-055481

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

We are searching for the best talent for Director PQV Trending and Insight to be in New Jersey and Pennsylvania.

The Director Trending and Insights leads the global process for trending product quality complaint data and generating actionable insights to drive proactive quality improvements across all JJ Innovative Medicine (IM) commercial products. This role provides oversight of complaint trending methodologies ensures compliance with regulatory standards and represents JJ IM during health authority inspections. The Director is accountable for delivering strategic insights through data analysis signal detection and product performance monitoring while fostering cross-functional collaboration with PQV PQM MSAT DPDS Regulatory Affairs Medical Safety and Commercial Quality teams. Responsibilities include managing product trends identifying signals and need for investigations maintaining risk registers supporting audit readiness and driving continuous improvement initiatives.

The Director ensures that complaint vigilance processes align with corporate standards and are executed using

appropriate system tools ultimately enhancing the complaint management process product quality patient safety

and regulatory compliance.

Key Responsabilities:

• Provides leadership and support in execution of the centralized complaint trending process and associated systems globally. Manages overall product quality complaint trending process including evaluating and coordinating within PQV and with JJIM business partners in the investigation of product quality complaints trends. Evaluates data and prepares routine and ad hoc reports for management and partners. Performs statistical analysis to identify trends/patterns in complaint data. Monitors complaint trending process for continuous improvement. Works with the business partners to ensure appropriate investigations are completed and closed in a timely manner.

• Establishes and maintains processes and procedures to ensure complaint trending is meeting and exceeded for timely processing and investigation of complaints notification to management insights and trending. Maintains a process for system surveillance and timely escalation to management of adverse trends within the product quality complaints data. Manages and oversees processes for system-wide collection and reporting of metrics that demonstrate the acceptable functioning of the quality system and illuminating areas for improvement.

• Focus on efforts to evaluate end to end complaint process insights and proactively drive quality improvements using complaint metrics process opportunities and benchmarking data. Collaborate with cross-functional teams to develop and implement effective action plans manage risk registers and support audit readiness. Drive robust complaint handling practices focusing on procedural enhancements and data to inform strategic decisions and to maintain high standards of quality and compliance. Leverage the Complaint Vigilance Review Board (CVRB) to inform and drive actions related to product and process risk.

• Leads or Participates on PQV and Commercial Quality project teams; supports development effective implementation continued maintenance and ensures compliance is achieved and standards are met. Represents PQV processes to regulatory agencies and support regulatory inspections. Ensures audit readiness of PQV processes and documentation. Liaison between PQV and Product Quality Management IM Supply Chain Quality Commercial Quality Medical Safety and other JJ IM organizations to ensure comprehensive cohesive and consistent process execution and documentation. This includes creation and maintenance of controlled documentation (e.g. Standards SOPs WI etc.) delivering training/orientation coordinating changes etc.

• Manages and provides leadership and organizational capability development and ensures succession planning and performance standards remain at an optimal level to maintain compliance. Incumbent will interact with Sr. Director Directors and Vice Presidents in JJ IM. Manages Trending team priorities assignments and performance. Perform process and system training as required.

Trending

• Lead strategic initiatives focused on trend analysis signal detection and data analytics to identify opportunities for product and process improvements across global JJ IM products. Partner cross-functionally to translate data into product insights that drive risk reduction and patient centric solutions leveraging analytical tools to generate insights that drive proactive quality enhancements and support continuous improvement of the JJIM products.

Product Insights

• Responsible for collaborating with PQV Product Oriented Delivery (POD) teams to generate actionable insights for business partners (regional CQ) and senior leadership leveraging product quality data to support decision-making participate in new product launch CQ governance and continuous improvement. Provide insights to business partners using complaint data (such as preference complaints) monitor product investigations and market feedback support forecasting (volume of complaints) and risk assessments and ensure timely follow-up on quality actions to drive compliance and enhance product understanding.

Process Insight

• Lead transforming end to end complaint process insights into proactive quality improvements by monitoring complaint metrics process opportunities and ensuring compliance with regulatory standards. Drive cross-functional collaboration to develop and implement effective action plans manage risk registers and support audit readiness. This role ensures robust complaint handling practices facilitates SOP enhancements and leverages data to inform strategic decisions and maintain high standards of quality and compliance.

External and Internal Interactions

• Analyze and present product quality complaint and compliance issues to senior management within JJ IM. Will interact with Directors VPs across all areas as well as internal audit organizations. Expected to interact with external regulatory bodies.

People Leader

• Responsible for leading a team that will use analytics for improving the JJ IM patient experience and driving efficiency/reliability of the complaints process and data. Serve as a talent accelerator who will acquire cultivate and develop best in class analytics talent ensuring coaching and development.

• The Director must have the ability to set the vision inspire action partner in achieving alignment earn the respect of others and drive cultural change be based on well-developed skills knowledge and experience (as identified in the overarching leader and technical capabilities).

• They must possess the maturity and competency to lead direct reports with proven performance records and mentor/coach/train those outside their direct influence in understanding and adhering to regulations. It should be expected that their leadership influence (implementing the vision and governance) must be extended across the JJ IM to ensure trends meet quality and compliance expectations.

• Participates directly or indirectly on regional and global complaint vigilance initiatives and project teams to develop consolidate and/or improve complaint vigilance trending product and process insights with related/interfacing processes.

Qualification:

• Bachelors degree or equivalent in technical life sciences or engineering field is required.

• A Registered Nurse Physician Assistant Biomedical Engineer or other related license/certification/degree or advanced degree in Pharmaceuticals Regulatory Quality Business etc. is helpful.

• A minimum of 10 years of professional experience in pharmaceuticals medical device diagnostics or related field is required. A proven experience of a team responsible for handling product quality complaints or related-similar activities is required

• Analyze and present product quality complaints and compliance issues to senior management within JJ IM. Will interact with Directors VPs across all areas as well as internal audit organizations. Expected to interact with external regulatory bodies.

• Direct experience with FDA and/or other regulatory audits/inspections is required.

• Experience with corresponding to inquiries associated with regulatory agencies is desirable

• Strong knowledge and understanding of regulatory requirements listed below is highly preferred.

• Experience/knowledge of most regulations relative to post market surveillance activities and reporting such as: ISO 9001/13485/14971 FDA Regulations (21 CFR (parts0etc.)) ICH Q8 9 & 10 CMDR JPAL and Medical Devices Directive (93/42/eec 98/79/EC)) is helpful.

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.

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