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:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Wilson, North Carolina, 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 Quality Systems Specialist to be onsite at Wilson, North Carolina.

While this role is in the project phase across both design & construction, you will be required to work on-site at a temporary location in Wilson, NC until the site is at an occupancy ready state with temporary building structures or work remotely based on distance from the temporary location. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

We are currently seeking a highly qualified individual to join our Quality Systems team as a Quality System Specialist at our new Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for carrying out tasks and projects related to Quality Systems activities as required by Good Manufacturing Practice (GMP).

The Quality Systems Specialist is an experienced Quality associate responsible for leading and/or supporting Quality Systems, which includes Document Management, Training, Deviations/CAPAs, Audits, Change controls, Gap Assessments, Specifications, Quality Agreements, Quality Management review and Annual Product Reviews within the scope of the organization.

Primary responsibilities include identifying or supporting continuous improvements to new or existing electronic quality systems, serving as the subject matter expert to electronic quality systems, drafting local procedures, leading or supporting training, and developing and reporting metrics. Other responsibilities include supporting management review forums, partnering with functional areas to ensure appropriate system use, and supporting regulatory inspections, in addition to other identified needs.

This position requires on-site presence at the Wilson manufacturing site once the site is operational.

You will be responsible for:

• Serve as the Quality Systems subject matter expert for the Wilson manufacturing site
• Provides support and direction to all departments regarding specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
• Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Carries out tasks related to the administration of site deviation management, change control management, and training systems using an Electronic Tracking System (ETS).
• Assist Quality Assurance with specifications, quality Agreement, and gap assessment activities within the scope of the organization.
• Support Management review (QSMR), documentation management, annual product review and validation compliance activities, as needed.
• Responsible for managing the assigned Quality Systems Metrics and supporting the implementation of all quality policies, procedures, and systems to assure compliance with Regulatory and Company requirements.
• Provides or supports Good Documentation Practice (GDocP) and GMP training to site personnel as directed by the Quality Systems Manager.
• Develops and maintains training materials for provision of GDocP and GMP training to site personnel of applicable systems.
• Supports Inspection readiness at the site as Quality Systems Subject Matter Expert.

Qualifications

Required:

• Bachelor's degree in scientific, engineering or technical disciplines.
• Minimum of 2 years of experience working in Quality and/or Compliance in the pharmaceutical industry
• Minimum of 2 years of experience managing workflows within electronic quality systems such as TrackWise, Master Control, Veeva, Compliance Wire, Success Factors, ZenQMS, or Documentum.
• Minimum of 2 years of experience leading or managing the elements of quality systems (deviations/nonconformances, change controls, training, documentation, annual product reviews, and gap assessments)
• Knowledgeable of FDA/HPRA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Self-motivated and innovative
• Collaborative and critical thinker

Preferred:

• A minimum of 4 years of experience working in Quality and/or Compliance in the pharmaceutical industry
• Experience in development or evolution of electronic GMP systems
• Start-up experience, highly desirable
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements
• Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams
• Proven ability to manage multiple priorities and work independently with minimal supervision
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment
• Ability to build and nurture strong and positive relationships.
• The ability to work in a team environment and interact with all levels of the organization

Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

If you are passionate about quality systems, GMP, documentation in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a Quality System Specialist. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.

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.

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