Senior Manager CQV

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 Spring House Pennsylvania United States of America Titusville New Jersey United States of America

Job Description:

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 Senior Manager CQV.This Hybrid position can be based in Titusville New Jersey Springhouse Pa or Raritan New Jersey.

#LI-Hybrid

CAR-T is an innovative treatment which uses the power of the patients own immune system. A patients T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. JJIM is working to develop manufacture and commercialize products in the CAR-T space.

The CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIMs Advanced Therapies Supply Chain. Along the lifecycle of our assets such as facilities equipment execution systems and utilities this role is the key point of contact for all technical matters related to Commissioning Qualification & Validation. The CAR-T (CQV) Lead is responsible for providing compliance expertise using J&J standards oversight and development of internal as well as external partnerships at the site level and beyond with a focus on Commissioning Qualification Re-qualification and Validation within the JJIM CAR-T facilities.

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. During Health Authority inspections and audits they are the first point of contact for asset & facility qualification-related matters and serve a leading role to ensure successful outcomes. Daily the CQV Lead partners with Operations MSAT Quality and 3rd party partners as well as Environment Health & Safety.

The CQV Lead will partner closely with global E&PS and Quality to ensure validation strategies are aligned with J&J standards and meet operational requirements. You will own the development and execution of the Project Validation Master Plan (PVMP) and ensure on-time qualified system turnover to the end user.

Key Responsibilities:
Ownership for the development and execution of the Project Validation Master Plan (PVMP)
Support the writing and approval of URSs (User Requirement Specifications) for facilities equipment and systems.
Ensure flawless execution of Commissioning Qualification and Re-qualification works for manufacturing and laboratory equipment execution systems as well as facilities and utilities
Lead the writing and execution of Impact Assessments for equipment and facilities IQ & OQ and Re-qualification as well as PQ activities
In partnership with E&PS own 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)
Accountable for cost and resources within system(s) of responsibility
Support resolving of technical issues or roadblocks as fast as possible including lessons learned
Support investigations deviations corrective and preventive actions towards successful timely and compliant closure
Leading role in compliance inspections / audits within area of responsibility
Ensure compliance with all applicable cGMPs global regulatory requirements safety environmental regulations SOPs WIs and Company policies and corporate standards
Provide leadership and act as expert in the field C&Q
Maintain partnerships with contractors and vendors that execute 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
Actively communicate regularly with the Engineering community and foster expertise sharing with CAR-T entities around the globe
Analyze processes to find opportunities for optimization efficiency improvements and cost savings.
Furthermore a portion of your time will be focused on developing detailed knowledge of CAR-T production processes:
Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding) operational procedures and manufacturing environment (Facilities Utilities Equipment Systems Processes)
Develop & maintain robust understanding of aseptic and cell processing techniques.
Develop & maintain an in-depth knowledge of cell processing robotics and automation.
Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

Qualifications:
Education:
Minimum of a Bachelors or equivalent University Degree required; advanced degree or focused degree preferred in Engineering Bioscience Engineering Industrial Engineering Pharmacy Biochemistry or related field.

Experience and Skills:
Required:
Minimum 8 years of relevant work experience.
Experience within Pharmaceuticals Biopharmaceuticals / Large Molecule or equivalent industry
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
Demonstrated ability to collaborate internally and externally within a matrix environment.
Demonstrated start-up mindset and you proactively search for solutions.
You prioritize and provide clear instructions to peers.
You thrive in a rapidly changing environment and lead as a change agent to promote flexibility creativity and accountability while at the same time handling procedures/ guidelines which require strict execution.
You work independently and successfully prioritizing and managing multiple tasks simultaneously and integrating cross-functional issues.

Preferred:
Experience with equipment / systems commissioning/qualification/validation Process Automation IT manufacturing systems cell therapy (CAR-T) is an asset
People leadership/management experience (direct or indirect reports)

Other:
Requires up to 30% domestic and/or international travel.
The anticipated base pay range for this position is $120000 to 207000.

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 :

120000- 207000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. 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)). This position is eligible to participate in the Companys long-term incentive program. 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Senior Manager