Senior Specialist, External Quality

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 jnj.com

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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, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Specialist, External Quality (Synthetics)! This position can be performed at Raritan or Titusville, NJ, Malvern, Spring House or Horsham, PA & Athens, GA. 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

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 with a focus in life science, engineering, physical science 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; demonstrates 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 applying process excellence tools and methodologies.

Other:

• This role may require up to 25% 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 & 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,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits