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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 Assurance

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson Innovative Medicine, is recruiting for a **Sr. Specialist, External Quality (Small Molecules)** . The preferred location for this position will be in **Horsham, PA** or **Titusville, NJ** . However, the role can also be located in **Athens, GA.**

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.

In this position you will provide end-to-end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

+ Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.

+ Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Support the escalation and issue management processes.

+ Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.

+ Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.

+ Build relationships with internal and external partners to meet patient supply requirements.

+ Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.

+ Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.

+ Provide quality oversight for tech transfer and new product introduction activities. Support a variety of projects both internally and with external manufacturers.

+ Act as a backup to External Quality account owners in support of external manufacturers as needed.

Qualifications

Education:

+ A minimum of a Bachelor's or equivalent University degree is required; a focus in Life Science, Engineering or Physical Science is preferred.

Experience and Skills

Required:

+ A minimum of 5 years working in a cGMP regulated environment.

+ Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation.

+ Ability to work independently in support of a portfolio of products and external manufactures.

+ Experience working on cross-functional project teams.

+ Strong communication and influencing skills, demonstrating an ability to communicate at all levels of the organization.

Preferred:

+ Experience working with external partners.

+ Experience with product transfer, new product introduction, medical devices, and combination products.

+ Proficient in utilizing process excellence tools and methodologies.

Other:

+ This role may require up to 10% of domestic & 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 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100,000- $173,500

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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)). • This position is eligible to participate in the Company’s long-term incentive program. • 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 Additional information can be found through the link below. For additional general information on Company benefits, please go to: • https://www.careers.jnj.com/employee-benefits 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. This job posting is anticipated to close on Date. 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. 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.