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Senior Specialist, EQ Supplier Quality - 2306141602W

Description

Janssen Supply Group, LLC is recruiting for a Senior Specialist, EQ Supplier Quality . The preferred work location is our Raritan, NJ site. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 Affairs.

Qualifications

Education:

• A Bachelor’s degree or higher is required, with a preference focused in Engineering or Science.

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.

• Capable of working remotely.

• Must be available for travel up to 25%, primarily within North America.

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 Affairs.

• Exposure to regulatory authority inspections.

The anticipated base pay range for this position is $90,000 to $144,000.

• 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)).

• 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.

https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-United States

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Job Function Quality (Generalist)

Req ID: 2306141602W