CQV & Compliance Lead

Johnson & Johnson Innovative Medicine•Raritan, NJ

22h

About The Position

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/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.

Requirements

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

Nice To Haves

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

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.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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