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

Job Function:

Quality

Job Sub Function:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Lead, ERP WMS CSV Leader! The location for this position is in Raritan, New Jersey, Horsham, PA or Irvine, CA!

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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/.

Enterprise Quality Computer System Validation (EQ CSV) owns the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ CSV is the authority for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.

The Lead, ERP WMS CSV Leader participates on project core teams for global ERP programs representing quality CSV. The candidate needs to demonstrate deep technical command of CSV regulations and ability to explain application of requirements to peer partners.

Key Responsibilities:

• The ERP/WMS Validation Lead is responsible for execution of quality computer system validation for enterprise-wide systems, tools, services and infrastructure through the end-to-end lifecycle of the application (design, develop, implement, maintain, retire).
• This position provides technical and procedural expertise/mentorship to the project teams, aligning with both internal and external collaborators as well as supports internal audits and Health Authority regulatory inspections
• This position will be responsible for the approval of SDLC validation documentation including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide EQ CSV compliance mentorship and support to project and base business support team members.
• This position serves as an encouraging partner across the EQ CSV organization, requiring collaboration skills.

Qualifications

Education:

• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field required. Confirmed, meaningful experience may be substituted when appropriate, additional certifications a plus.

Experience and Skills:

Required:

• 6 years of multifaceted experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required.
• SAP understanding with previous participation in an SAP implementation program.
• Broad understanding of SDLC Quality Management processes, Computerized System Validation/Computerized System Assurance principles as well as demonstrated knowledge of cGMP regulations related to CSV.
• Awareness of cybersecurity and privacy principles and implications for quality and risk management activities.
• Experience authoring and/or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required.
• Experience supporting global technology programs along with FTEs/consultant teams across multiple geographies.

Preferred:

• Ability to collaborate with collaborators multi-functionally demonstrating command of the Quality CSV requirements and how applied.
• Curiosity to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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.

The anticipated base pay range for this position is :

$91,000-$147,200

Additional Description for Pay Transparency:

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. http://www.careers.jnj.com/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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.