CQV & Compliance Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 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 addition they will create and sustain continuous procedural improvements to boost efficiency of C&Q activities. Fosters a qualityfirst mindset across Engineering Maintenance Facilities and Automation by providing proactive leadership and crossfunctional 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 Bachelors 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 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 :

$122000.00 - $212750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: -