Johnson & Johnson
Senior RA Professional Submissions CAPAs
Johnson & Johnson, Titusville, New Jersey, us, 08560
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:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a
Senior RA Professional, Submissions, CAPAs . This hybrid work position will be located in Raritan, NJ or Titusville, NJ.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Warsaw, Poland; Leiden, The Netherlands - Requisition Number:
R-034278
High Wycombe, United Kingdom - Requisition Number:
R-036049
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
The CAPA Lead is a strategic role within the Next Gen Submissions (NGS) function, responsible for driving quality, compliance, and continuous improvement across the regulatory submissions lifecycle and publishing lifecycle. This role ensures that CAPA activities are executed in compliance with applicable regulatory requirements, company policies, and industry best practices. The CAPA Champion acts as a subject matter expert, coach, and facilitator—supporting cross-functional teams to identify root causes, implement robust corrective/preventive measures, and verify long-term effectiveness.
Main Duties and Responsibilities:
~50% of time:
CAPA Oversight
Serve as the Next Gen Submissions lead for the CAPA process, ensuring timely initiation, investigation, implementation, and closure of Non-Conformances and CAPAs.
Monitor CAPA progress, provide guidance on documentation quality, and ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO standards).
Maintain CAPA metrics and dashboards to drive transparency and accountability.
Root Cause Analysis & Quality Improvements
Facilitate structured root cause investigations using recognized methodologies (e.g., 5 Whys, Fishbone, FMEA).
Partner with stakeholders to design effective corrective and preventive actions that address systemic issues and reduce recurrence.
Evaluate CAPA effectiveness and recommend adjustments where necessary.
~40% of time:
Process Improvement & Governance
Identify opportunities for improving CAPA workflows, tools, and templates.
Contribute to the development and maintenance of CAPA-related SOPs, policies, and work instructions.
Identify automation and process simplification opportunities to optimize submission processes.
Champion best practices and standardization across Next Gen Submissions.
Support Knowledge Management activities including maintenance knowledge management technology platform and regulatory submission processes documentation.
~10% of time:
Training & Coaching
Act as a CAPA process subject matter expert (SME), providing training, mentoring, and coaching to Next Gen Submissions employees.
Promote a culture of continuous improvement and proactive issue resolution.
Qualifications Required
University/Bachelor’s degree or equivalent experience and generally 6 years of pharmaceutical industry or related experience.
2 years in regulatory affairs/operations or quality systems
Root Cause Analysis methodologies
CAPA systems, Regulatory Document Management
Preferred
Masters/Pharm D/PhD with 1-3 years’ experience
3–5+ years in regulatory operations or GxP environment
Lean Six Sigma Black Belt
The anticipated base pay range for this position is :
91.000 - 147.000
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)). This position is eligible to participate in the Company’s long-term incentive program. 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
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a
Senior RA Professional, Submissions, CAPAs . This hybrid work position will be located in Raritan, NJ or Titusville, NJ.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Warsaw, Poland; Leiden, The Netherlands - Requisition Number:
R-034278
High Wycombe, United Kingdom - Requisition Number:
R-036049
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
The CAPA Lead is a strategic role within the Next Gen Submissions (NGS) function, responsible for driving quality, compliance, and continuous improvement across the regulatory submissions lifecycle and publishing lifecycle. This role ensures that CAPA activities are executed in compliance with applicable regulatory requirements, company policies, and industry best practices. The CAPA Champion acts as a subject matter expert, coach, and facilitator—supporting cross-functional teams to identify root causes, implement robust corrective/preventive measures, and verify long-term effectiveness.
Main Duties and Responsibilities:
~50% of time:
CAPA Oversight
Serve as the Next Gen Submissions lead for the CAPA process, ensuring timely initiation, investigation, implementation, and closure of Non-Conformances and CAPAs.
Monitor CAPA progress, provide guidance on documentation quality, and ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO standards).
Maintain CAPA metrics and dashboards to drive transparency and accountability.
Root Cause Analysis & Quality Improvements
Facilitate structured root cause investigations using recognized methodologies (e.g., 5 Whys, Fishbone, FMEA).
Partner with stakeholders to design effective corrective and preventive actions that address systemic issues and reduce recurrence.
Evaluate CAPA effectiveness and recommend adjustments where necessary.
~40% of time:
Process Improvement & Governance
Identify opportunities for improving CAPA workflows, tools, and templates.
Contribute to the development and maintenance of CAPA-related SOPs, policies, and work instructions.
Identify automation and process simplification opportunities to optimize submission processes.
Champion best practices and standardization across Next Gen Submissions.
Support Knowledge Management activities including maintenance knowledge management technology platform and regulatory submission processes documentation.
~10% of time:
Training & Coaching
Act as a CAPA process subject matter expert (SME), providing training, mentoring, and coaching to Next Gen Submissions employees.
Promote a culture of continuous improvement and proactive issue resolution.
Qualifications Required
University/Bachelor’s degree or equivalent experience and generally 6 years of pharmaceutical industry or related experience.
2 years in regulatory affairs/operations or quality systems
Root Cause Analysis methodologies
CAPA systems, Regulatory Document Management
Preferred
Masters/Pharm D/PhD with 1-3 years’ experience
3–5+ years in regulatory operations or GxP environment
Lean Six Sigma Black Belt
The anticipated base pay range for this position is :
91.000 - 147.000
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)). This position is eligible to participate in the Company’s long-term incentive program. 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