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.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are currently seeking a highly qualified individual to join our Quality System 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). These activities include change control, nonconformance investigation, complaints and CAPA system, Specifications, Quality Agreements and Gap Assessments management within the scope of the organization, Training, Management review (QSMR), documentation management, annual product review and validation compliance activities, among others.

Essential Job Duties and Responsibilities:

• Provides support and direction to all departments in respect of 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 nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
• Assist Specifications, Quality Agreements and Gap Assessment management activities within the scope of the organization.
• Support Management review (QSMR), documentation management, annual product review and validation compliance activities, as required.
• 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 training in Good Documentation Practice (GDP) and GMP to site personnel as directed as directed by the Quality Systems Manager.
• Develops and maintains training materials for provision of GDP and GMP training to site personnel of applicable systems.
• Supports Inspection readiness at the site as Quality Systems SME.

Qualifications

Required:

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum of 8 years of experience working in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
• 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.

Preferred:

• Experience in development/and or evolution of GMP systems and/or 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, with the ability 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.

This job posting is anticipated to close on 12/31/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base pay range for this position is $69,000 to $111,550. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.