Senior Manager Post-Market Surveillance

Johnson & Johnson is currently recruiting for a Senior Manager Post-Market Surveillance! This position can be located in Cincinnati, OH, Danvers, MA, Irvine, CA or Raritan, NJ.

Role focus: Accountable for the end-to-end design, performance and advancement of a defined global Post Market Surveillance processes. This role owns the process strategy, translation of business requirements into technical solutions, including accountability for governance of vendor-supported complaint and post-market quality services. 

Position Summary:

The Senior Manager, Post-Market Surveillance Governance is responsible for the global governance, effectiveness, and continuous improvement of MedTech Post-Market Surveillance processes, systems, data, analytics, and reporting. The role leads the enterprise Post-Market Surveillance operating model across MedTech Business Units, ensuring regulatory readiness, consistent execution, data integrity, timely signal detection, and delivery of Post-Market Surveillance plans, reports, and related regulatory documentation.  This leader will be responsible for the Business technical systems requirements & delivery for all quality system applications and digital solutions to support process execution. 

The role also provides governance and operational oversight for vendors supporting complaint management, Post-Market Surveillance, analytics, and related post-market quality services. This accountability includes translating quality and business requirements into supplier expectations, monitoring service, quality, compliance, capacity, and cost performance, and driving timely escalation, corrective action, and value creation. The position partners across franchises, Medical Safety, Regulatory, Clinical, Engineering, Quality, Global Services, Procurement, Finance, Information Technology, and external suppliers to deliver compliant, scalable, efficient, and insight-driven post-market outcomes. 

Key Responsibilities:

In accordance with all applicable federal, state, and local laws and regulations and Johnson & Johnson procedures and guidelines, this position, under limited supervision: 

• Provide global governance for Post-Market Surveillance procedures, systems, data, analytics, and reporting, including strategic planning and impact assessments for emerging regulations, standards, and health authority expectations. 

• Lead the MedTech Post-Market Surveillance operating model across franchises, promoting consistent, scalable, and risk-based execution for complaint trending, signal detection, Post-Market Surveillance plans, Post-Market Surveillance reports, and related regulatory documentation. 

• Interpret Post-Market Surveillance requirements and translate them into practical policies, procedures, systems, controls, training, and implementation plans that support patient safety, regulatory compliance, proactive risk management, and cost efficiency. 

• Oversee methods for identifying, analyzing, evaluating, documenting, and escalating potential product signals, including complaint-rate trends, adverse-event rates, part usage, and other product-performance indicators. 

• Support data scientists and other assigned team members in developing, maintaining, and advancing analytical methods, algorithms, digital tools, systems, and responsible artificial intelligence capabilities used by Post-Market Surveillance and vigilance teams. 

• Ensure appropriate governance of data quality, analytical methods, statistical rationales, validation, documentation, change control, and technology sustainability. 

• Drive continuous improvement and harmonization of global Post-Market Surveillance processes through automation, standardized data models, reporting tools, digital enablement, and cross-business adoption of best practices. 

• Partner with franchise, Medical Safety, Regulatory, Clinical, Engineering, Quality, and executive stakeholders on surveillance priorities, product signals, new product launches, acquisitions, integrations, corrective and preventive actions, and ad hoc data-analysis needs. 

• Support applicable Post-Market Surveillance submissions, health authority responses, audits, inspections, compliance reviews, and gap assessments. 

• Provide governance and operational oversight for vendors supporting complaint management, Post-Market Surveillance, analytics, and related post-market quality services. 

• Translate business, quality, privacy, information-security, and regulatory requirements into clear vendor scopes, service levels, quality expectations, performance measures, escalation pathways, and governance routines. 

• Monitor vendor performance using service, quality, compliance, timeliness, capacity, cost, and process-health indicators; identify trends, escalate material risks, and drive corrective and continuous improvement actions. 

• Partner with Global Services, Procurement, Quality, Finance, franchises, and suppliers on vendor selection and lifecycle activities, purchase-order and invoice coordination, capacity planning, contract-related operational inputs, and cost management. 

• Identify and advance value-creation opportunities through service optimization, technology enablement, automation, standardization, capacity management, and continuous improvement. 

• Establish goals, monitor performance, coach and develop staff, ensure appropriate training, and support succession and resource planning. 

• Communicate business-related risks, issues, decisions, and opportunities to the next management level with appropriate urgency and clarity. 

• Follow all Company guidelines related to Health, Safety, and Environmental practices and ensure assigned staff have the resources needed to comply. 

• Ensure personal and Company compliance with all applicable federal, state, local, international, and Company regulations, policies, and procedures. 

• Perform other duties as assigned.

Qualifications:

Education:

A minimum of a Bachelor’s degree in a technical field (for example, Data Science, Biostatistics, Epidemiology, Public Health, Quality Engineering, Biomedical Engineering, Computer Science, Biology, etc.) or a related field including significant experience working in pharmaceutical, consumer, medical device or another highly regulated industry is required. Advanced degree preferred.

Required:

• A minimum of 8 years of related work experience.

•  A minimum of 5 years of Quality Assurance experience in the medical device, diagnostic, pharmaceutical, or other regulated industry.

•  Previous supervisory/people-management experience.

• Proven ability to work efficiently with general or limited supervision, including in a remote-office environment.

• Demonstrated leadership skills and ability to work in environments with fluctuating and competing priorities.

• Proven advanced critical-thinking skills, including quantitative and qualitative analysis and investigation.

• The ability to understand and follow complex written procedures is required. 

• A demonstrated ability to work effectively with cross-functional teams for complaint trend investigation, post market surveillance, root cause analysis, identification and implementation of CAPAs.

• The ability to function in a team environment and deliver on team objectives.

•  Demonstrated initiative in delivering strategy objectives, working through ambiguity, meeting deadlines, and developing high-performing teams.

• Ability to influence, drive and manage change.

• Proven leadership in developing and coaching staff.

• Ability to communicate effectively and present clear technical results to non-technical audiences.

• Demonstrates positive CREDO behaviors and demeanor that reflect understanding and support of the organizational values.

• Strong attention to detail.

Preferred:

• Ability to multitask, with an established track record of meeting milestone schedules.

• Strong background in statistical and data analysis, data management, and data processes, including knowledge of data-science and data-management software technologies.

• A high level proficiency in reading, writing, and speaking the English language.

• Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.

Other:

This position may require up to 15% domestic & international travel.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.