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:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Janssen Supply Group, LLC a member of the Johnson & Johnson Family of Companies is recruiting a Senior Specialist, EQ Supplier Quality! This position can be located in Spring House or Malvern, PA, Raritan, NJ and Gurabo, PR.

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/.

We are part of the Janssen Supply Chain (JSC), a global organization responsible for supplying medicines to markets and patients around the world. With Supplier Quality as our primary focus, we strive to provide access and affordability through innovation and collaboration with our Internal Sites, Procurement, R& D, and other Commercial partners to deliver life changing solutions for patients in need.

Are you ready for a new opportunity within our organization?

As a Senior Specialist within EQ Supplier Quality, you will ensure quality and compliance for suppliers in adhering to policies, enterprise standards and regulatory guidelines. As Janssen is part of Johnson & Johnson, you will represent the J& J Credo and its Quality Principles.

Key Responsibilities:

• Manage a portfolio of suppliers including performing of supplier qualification activities; primarily for suppliers within North America.
• Be responsible for quality engagements with suppliers to identify and implement improvements regarding their performance, quality, and cost.
• Document risk assessments of a supplier's quality systems by the means of on-site audits, questionnaires, or other tools to assure the quality and conformity of supplied materials.
• Be involved in assessing the impact of supplier change management, non-conformances, compliance issues, and corrective actions.
• Establish and perform periodic review of Quality Agreements.
• Lead and participate in projects and optimization initiatives to improve supplier management processes.
• Collaborate with partners such as Site Quality, Operations, Procurement, R& D, and Regulatory Compliance.

Qualifications

Education:

A minimum of a Bachelor’s or equivalent University degree is required with a focus in Engineering or Science preferred.

Experience and Skills:

Required:

• 5 or more years of demonstrated experience in quality management, production, quality control, or R& D in a pharmaceutical and/or biotechnology environment or similar.
• Knowledge and experience with cGMP regulations and ICH guidance.

Preferred:

• External auditing experience as a lead auditor.
• Experience handling the quality oversight of external suppliers or manufacturers, including selection, qualification, and monitoring.
• Experience using risk management strategies and tools.
• Experience with change control, investigation & complaint handling, corrective actions, and quality agreements.
• Experience collaborating in a highly cross functional environment including interacting with areas such as Site Quality, R& D, Operations, Procurement, and Regulatory Compliance.
• Exposure to regulatory authority inspections.

Other:

• Location: Malvern, Pa; Springhouse, PA; Raritan, NJ, Gurabo, PR.
• This position may require up to 25% domestic travel.
• The anticipated base pay range for this position is $91, 000–147, 200 USD Annual
  - 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)).
  – 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.]

The anticipated base pay range for this position is:

$91, 000–147, 200 USD

Additional Description for Pay Transparency:

• The anticipated base pay range for this position is $91, 000–147, 200 USD Annual - 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)). – 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