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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a CQV & Compliance Lead to join our Team in Raritan, NJ!

The Engineering, Maintenance, Facilities and Automation (EMFA) organization provides ownership and oversight for the entire asset portfolio and associated business processes for J&J Advanced Therapies Supply Chain globally.

The CQV & Compliance Lead is responsible for providing compliance expertise, using J&J Quality standards, oversight, and development of internal as well as external partnerships with a focus on Commissioning, Qualification, Re-qualification, and Validation within the Raritan CAR-T facilities. This role will also lead C&Q strategy and execution for new technologies introduced at the site. The Lead will provide day-to-day management of C&Q and Requalification activities, and work closely with different teams, vendors, sites, and partners. In addition, they will create and sustain continuous procedural improvements to boost efficiency of C&Q activities. Fosters a quality‑first mindset across Engineering, Maintenance, Facilities, and Automation by providing proactive leadership, and cross‑functional alignment to ensure adherence to J&J Quality standards.

Key Responsibilities:

• Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment as well as facilities and utilities

• Ownership for the Validation Master Plan (VMP)

• Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities

• Owner for Computer Systems Validation, including writing and driving CSV protocols, Functional Specification (FS), Design Specification (DS) plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ), and Functional testing (OQ)

• Support creation of Change Controls and User Requirement Specification (URS), as well as FMEA as needed

• Drive investigations, deviations, and corrective and preventive actions towards successful and compliant closure as it relates to equipment qualified state performance

• Assure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WIs, Company policies, and corporate standards

• Provide leadership and act as expert in the field C&Q

• Maintain partnerships with contractors and vendors that handle C&Q, Re-qualification, and PQ activities

• Establish and manage critical metrics and tracking tools across C&Q scope

• Site requalification activities at the Quality Site Management Review (QSMR) level

• Oversee compliance program for Facilities, Maintenance, Automation, and C&Q to sustain audit readiness, ensure timely SOP reviews, and oversee corrective actions and continuous improvement.

Qualifications:

Education:

• Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Engineering, Science, or related field preferred

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience

• Experience leading and executing commissioning and qualification activities

• Experience with Health Authority Inspections as well as internal and external audits

• In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, FAGG/FAMHP, ISPE)

• Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met

• Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of C&Q tasks, while identifying areas of improvement

• Excellent written and verbal communication skills including experience writing procedures for a technical environment, documenting complex technical solutions, and communicating effectively with internal and external partners

Preferred:

• People leadership/management experience (direct or indirect reports)

• Experience with Trackwise, SAP, and/or truVault system

• Experience within the Pharmaceutical industry

• Experience within Manufacturing (GxP) environment

• Experience working in a large, highly-matrixed environment

• Project Management certification

Other:

• Requires up to 10% domestic and/or 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:

Business Process Management (BPM), Coaching, Controls Compliance, Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Team Management, Technical Support

 

 

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
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits