Lead, Technology Regulatory Compliance Business Operations - Johnson and Johnson
Raritan, NJ 08869
About the Job
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 https://www.jnj.com/ .
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Technology Regulatory Compliance (TRC) Business Operations Lead supports group functional operations and performs strategic program activities, including performance analytics for J&J Technology Regulatory Compliance (TRC). In this role you will promote ideal practices for metrics & measurement and help make data more accessible and meaningful and drive the end-to-end delivery of platforms to supervise, visualize, and optimize the overall performance of TRC!
Key Responsibilities:
- Serves as the system administrator for the TRC audit information management system, which enables the execution of TRC audits and assessments of GxP systems.
- Lead project management, program governance and status reporting for TRC strategic and continuous improvement initiatives, including those related to the execution of strategic initiatives.
- Develops and maintains procedures and knowledge articles associated with Technology Regulatory Compliance (TRC) use of audit information management system(s). Provides training and ongoing educational opportunities to improve process awareness.
- Ensures/executes timely and accurate audit and periodic review data entry in audit information management system and identifies opportunities for application enhancement to improve usability.
- Acts as a data steward to ensure a high level of data integrity and ensures timely, consistent, accurate and reliable data to support strategic business decision making.
- Gathers data, researches, and analyzes specific business problems to identify and correct root cause of issues.
- Supports development of key data related to inspections, audit and periodic review program artifacts, and audit status.
- Conducts collection of reporting requirements, including enhancements and additional reporting/analytics needs.
- Works closely with multiple business partners to understand and interpret the organization's desired outcomes, manage requirements, and enable creative dashboards, visualizations, and analysis reports for TRC use.
- Responsible for application interfaces to and interdependencies with the TRC data mart and related Tableau reports that support operational and management reporting.
- Applies technical expertise in data mining and reporting tools (e.g., SQL, Spotfire, Microsoft Excel/SharePoint/Teams apps) to create reports and analyze compliance program data.
- A minimum of a Bachelor's degree or University equivalent, required with a concentration in Information Technology, Computer Science, Business, or related field is preferred.
- A Master of Business Administration (MBA) degree, or MBA degree in-process is preferred.
Required:
- A minimum of four (4) years of experience in a Compliance, Quality, Finance, or Technology related field.
- Demonstrated business process knowledge (e.g., CSV or Drug/Product development) and/or business process Improvement experience.
- Experienced with one or more of the following: Power BI, Power Automate, Power Apps, Data Warehouses, extract/transform/load processes, Data Lakes, Data visualization tools (e.g., Alteryx, Tableau).
- Computerized system experience and/or data science experience (e.g., database, data mining, modeling, and/or data analytics).
- Experience in information systems and/or GxP auditing within Pharmaceutical/Medical Device company or direct experience with GxP Quality Assurance, development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company.
- Knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems.
- Experience interpreting regulations and translating regulatory requirements into practical strategies.
- Experience working with Quality Management Systems and/or auditor experience.
- Strong interpersonal and organizational skills as well as the ability to effectively communicate at all levels within the organization, including making complex concepts understandable.
- Demonstrated positive relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally with a customer centric attitude.
- This position will be located in Raritan, NJ and may require up to 10% domestic or international travel.
- 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 corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
This job posting is anticipated to close on November 6, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
