LEAD, COMPUTER SYSTEM VALIDATION (CSV) QUALITY

Johnson & Johnson is recruiting for a Lead, Computer System Validation (CSV) Quality, to be located in Raritan, NJ, Horsham, PA or Danvers, MA.
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.
nj.
om/.
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.
Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance.
It encompasses a MedTech Deployment Office division that supports Computer System Validation and deployment of GxP IT systems.
This organization has a focus on new and innovative technologies and implementing the appropriate quality controls for the determined risk profiles.
The Lead, CSV Quality is responsible for guiding and managing the team throughout the building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).
Additionally, they are responsible to implement projects and support multiple base business changes for GxP IT systems by adopting a risk based approach to Validation.
Key Responsibilities.
Responsible for the execution of GxP systems by adhering to approved procedures and policies.
Responsible to lead Computer System Validation of ERP/WMS, R&D and Commercial systems.
Facilitates and communicates key messages and presentations to various cross-functional groups to gain support.
Able to lead multiple projects and manage timelines while overseeing contract resources.
Develop and implement risk based approach to CSV.
This role will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use and provide quality and compliance guidance to project and base business support team members This role will promote an environment which encourages the company’s credo and the value of a diverse workforce.
This role serves as a trusted partner across the Enterprise Quality & Compliance organization, requiring strong collaboration skills.
The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications This position will support internal audits and Health Authority regulatory inspections Qualifications Education.
University/Bachelor’s or equivalent degree is required.
Experience and Skills.
Required.
A minimum of four to six (4-6) years of related experience in a Quality, Validation and/or IT function.
Progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology activities.
Experience in identifying areas of potential compliance risks and implementing strategies to reduce those risks.
Experience with executing, and/or management of IT CSV projects.
Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report Must be familiar with procedures, work instructions, forms and templates.
Must be familiar with Change Control and NC/CAPA generation/approval Work effectively in a virtual global team environment.
Strong influencing and interpersonal skills, both verbal and written and both at business and technical levels.
Strong work ethic with ability to build passion around achieving objectives.
Solid understanding of SDLC, Jira, QTest, automated test tools like TOSCA, code repository like Bitbucket and change control/management systems like IRIS/Service Now and Solman.
Preferred.
Experience across multiple teams or job functions related to Quality and/or Technology.
Familiarity with GAMP-5, 21 CFR-Part-11 and CSA.
Knowledge of Technology systems and process analysis tools.
Other.
The anticipated base pay range for this position is $ to $.
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)).
Employees are eligible for the following time off benefits.
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 Additional information can be found through the link below.
https://www.
areers.
nj.
om/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
areers.
nj.
om.