Johnson & Johnson
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.
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. 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. 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. 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, please contact us via https://www.jnj.com/contact-us/careers.
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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. 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. 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. 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, please contact us via https://www.jnj.com/contact-us/careers.
#J-18808-Ljbffr