Senior Manager, Post Market Surveillance - Data ...

The Senior Manager, Post Market Surveillance - Data Science Center of Excellence will be responsible for leading the post market surveillance program spanning across the Johnson & Johnson MedTech portfolio. The position resides within the post market center of excellence and responsibilities of the role span across multiple sites and multiple lines/products with an emphasis on complaint trending, signal detection, data management, data science, advanced analytics, and post market surveillance planning and reporting processes. This position can be in Irvine, CA; Cincinnati, OH; Raritan, NJ; West Chester, PA; or Raynham, MA; Warsaw, IN, remote considered on a case by case basis. Up to 20% travel for this role may be required. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson MedTech Companies produce a broad range of innovative products and solutions used primarily by health care professionals in key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, Neurovascular care, and Cardiovascular surgical products. As the most comprehensive medical device business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. Johnson & Johnson Medical Devices is currently at $20 billion in Worldwide sales. The business is expected to experience solid growth over the next 5 to 7 years. Section 2: duties & responsibilities Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations, and Corporate Johnson & Johnson, procedures and guidelines, this position: Leads the MedTech Post Market Surveillance processes including monthly signal detection, complaint trending and post market surveillance plans and reports to be used as product quality and safety monitoring and as an input into technical, safety and regulatory documentation across the MedTech product portfolio. Develops a deep understanding of the post market data and partners with cross-functional audiences (e.g. clinical, medical safety, quality engineering, complaints, quality systems etc.) to ensure the integrity, consistency, compliance and alignment of the end-to-end post market surveillance processes for MedTech companies. Lead, develop and deliver descriptive, prescriptive, and predictive analytics to uncover deep post market insights, drive innovation, deliver on strategic objectives and ensure strong compliance of highly effective post market signal detection processes. Responsible for the deployment and maintenance of post market signal detection algorithms, data science applications and programming scripts required to execute the MedTech post market surveillance processes. Develops novel digital and data science applications, applies machine learning, statistical methodologies and data visualization techniques to ensure rigorous product quality and safety signal monitoring. Continuously assesses and monitors the high and growing needs across the organization for post market data and develops strategies (including digital applications, process improvements, intelligent automation, statistical methods etc.) to drive efficient and quick access to insights and reporting. Ensures support of appropriate post market surveillance related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures and provides support during external and internal audits of the Post Market Surveillance processes. Performs other duties assigned as needed QualificationsSection 3: experience and education A minimum of a bachelors degree in a technical field (for i.e., Data Science, Biostatistics, Epidemiology, Quality Engineering, Biomedical Engineering, Computer Science, etc.) or a related field. Advanced Degree is preferred. Experience working in pharmaceutical, medical device or another highly regulated industry is required. A minimum of 8 years of related work experience is required. 5+ years of related experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry is required. SECTION 4: KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Key skills include but are not limited: Proven track record to work efficiently with general or limited supervision and in a remote office environment is required. A strong background in statistical/data analysis, data management and data science are required. Experience defining use cases for advanced analytics, machine learning, digital and data science to support business objectives and drive efficient execution is preferred. Experience with data science tools and statistical programming languages such as R is required. Prove ability to demonstrate critical and forward thinking, bigger picture vision, foresight, and change management to build and grow new solutions and processes in complex matrix organizations, as well as ambiguous environments is preferred. Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), compliance and document change control practices is preferred. Personal skills needed include assertiveness, tact, open-mindedness, forward thinker, maturity, tenacity, decisiveness, self-reliance and sound judgment. Persuasive, effective interpersonal skills are essential with an ability to work effectively across JnJ segments and functions at all levels of the organization. The ideal candidate should have excellent oral and written communication skills. Detailed understanding of the changing ecosystem of external regulations and data such as, Real-World Data and publicly available data assets and technologies that would benefit a post market surveillance data science team is preferred. Previous supervisory/people management experience is required, including developing and coaching staff is required. Demonstrate positive CREDO behaviors and demeanor that reflect understanding and support of the organizational values is required. Other: The anticipated base pay range for this position is $112,000 to $169,000 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 corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Primary LocationUnited States-New Jersey-Somerville-Other LocationsNorth America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States, North America-United States-California-Irvine, North America-United States-New Jersey-Raritan, North America-United States-Massachusetts-Raynham, North America-United States-Pennsylvania-West ChesterOrganizationMedical Device Business Services, Inc (6029)Job FunctionQualityRequisition ID2206065863W

Created: 2025-11-15