Senior Manager Post-Market Surveillance

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager Post Market Surveillance! This position can be located at any US J&J site.

Position Summary:

The Post Market Surveillance Senior Manager is responsible for ensuring post-market surveillance processes are compliant, effective, and efficient in line with evolving global regulations. This role provides governance for procedures and systems and oversees the post-market surveillance program across MedTech franchises, with emphasis on complaint trending, signal detection, data management, and data analysis.

Key Responsibilities:

• Provides governance for post-market surveillance procedures and systems, including strategic planning for emerging regulations.
• Leads market engagement to identify insights and opportunities for Customer Quality and Customer Experience Engineering, including processes to support new product launches and acquisitions/integrations.
• Serves as a leading voice in the interpretation of regulatory requirements and advocates for policies and procedures that best support patient safety, proactive regulatory-risk management, and cost efficiency.
• Leads a team of data scientists to develop, maintain, and advance data-analysis methods, processes, tools, systems, and capabilities (including Artificial Intelligence [AI]) used by MedTech post-market surveillance and vigilance teams.
• Supports MedTech franchise post-market surveillance improvements and related corrective and preventive actions, as required.
• Ensures each staff member has clearly established goals and objectives; monitors performance; supports development planning; conducts periodic performance evaluations and compensation planning; and ensures succession planning for key positions, including own.
• Develops, coordinates, and otherwise ensures appropriate training for associates.
• Reviews and continuously leads efforts to improve global post-market surveillance processes.
• Provides tools and procedures that enable rigorous data analysis (e.g., trending of complaint rates over time, part usage, and adverse event rates) and summarizes trends and potential signals, escalating as required.
• Manages stakeholders for processes that consume or provide inputs to post-market surveillance, including executive leadership, medical safety, and other business leaders.
• Oversees the timely completion and delivery of post-market surveillance plans and reports for company products, for use as inputs to technical, safety, and regulatory documentation.
• Oversees methods for analyzing, evaluating, and escalating potential post-market product signals. Maintains and continuously improves procedures, processes, and systems for complaint-data analysis and signal detection.
• Responsible for development of signal detection algorithms and data analysis programs.
• Ensures appropriate governance of data analysis quality and documentation of appropriate statistical rationales.
• Continually optimizes data analysis techniques and tools to advance capabilities and efficiency while striving to drive consistency across businesses.
• Ensures support of appropriate post market surveillance related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures.
• Supports CAPA, compliance, quality, and business objectives by overseeing completion of ad hoc post-market data-analysis projects and queries.
• Provides support during external and internal audits of post-market surveillance processes.
• Remains informed of new or revised regulations and guidelines and assesses impacts on company product-analysis processes.
• Completes detailed gap assessments to internal and external regulations and standards.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
•  For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits