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Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Risk Management Specialist! This position will be located in Raritan, NJ.

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, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The Sr. Risk Management Specialist will support Risk Evaluation and Mitigation Strategies (REMS) and general risk management activities for the Raritan, NJ Advance Therapies (AT) site.

Key Responsibilities:

• Develop and support risk assessments for the Raritan manufacturing site.
• Assist and lead development of and updates to SOPs and technical documents.
• Assist in developing and maintaining robust metrics and measure for risk management program.
• Support audits and inspections readiness and participate in site inspections and audits from internal and external regulatory agencies.
• Assist in developing and maintaining robust risk management program and compliance documentation.
• Other duties will be assigned, as needed.

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent University degree is required.

Experience and Skills:

Required:

• Minimum four (4) years of experience in Risk management program, Regulatory Affairs, Pharmacovigilance, Medical Writing or similar.
• Excellent interpersonal, influencing, written and verbal communication, listening, negotiating and problem-solving/decision-making skills.
• Ability to work in an ambiguous environment.
• Highly organized and capable of working with a cross-functional team.
• Strong knowledge of risk management principles and tools.
• Experience in applying ICH Q9 principles and risk-based approaches to the risk management program.
• Practical knowledge of regulatory aspects of current Good Manufacturing Practice.
• Strong critical thinking for evaluating risks across the site.

Preferred:

• Knowledge of National and International manufacturing regulatory requirements (e.g., FDA/EU guidance).
• Knowledge of Good Tissue Practices.
• Familiarity with SAP, MES (electronic batch records), COMET (quality event management), or equivalent systems.

Other:

• Occasional weekend and off shift support may be required.
• Requires up to 10% domestic travel.
• The anticipated salary for this position is expected to be between $77, 000- $124, 200 USD$

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.

#car-t

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.

The anticipated base pay range for this position is:

• The anticipated salary for this position is expected to be between $77, 000- $124, 200 USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits