Senior Specialist, QA GCP Auditor - Johnson and Johnson
Titusville, NJ 08560
About the Job
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/ .
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
In R&D Quality, we continue to invest in our talent, diversity, and expertise, to make quality a business differentiator and competitive advantage - allowing our business partners to better deliver what really matters to customers and patients. QA delivers innovative risk-based audit and quality control approaches that provide relevant insights to proactively secure compliance and drive sustainability and reliability across Johnson & Johnson Innovative Medicine.
As a QA GCP auditor, you will have the opportunity to have an impact on clinical research by assuring quality across multiple audit types, supporting with inspection management, and contributing to innovations in our ways of working.
Key Responsibilities:
Leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
- Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
- Analyzes, interprets data and identifies patterns and trends in data sets.
- Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.
- Presents information logically and concisely, both verbally and in writing, including writing reports with clarity
- Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)
- Supports regulatory inspections in various supporting roles.
- Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
- May assist in the preparation of training material if requested.
- Participates in projects or serves on teams, as assigned by supervisor.
- Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
- A minimum of a Bachelor's degree is required.
Required:
- A minimum of four (4) years of relevant work experience.
- Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
- Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2)
- Understanding of fundamentals of clinical trial risk management.
- Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
- Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.
- Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.
- Flexibility to respond to changing business needs.
- Ability to travel within the region
- Familiarity with new and emerging technologies and analytics, and the ability to see opportunities where creative capabilities may be applied within QA audit processes
- Experience conducting Clinical Quality Assurance audits.
- Ability to interpret global regulatory standards.
- Inspection support experience (FDA, EMA and other inspectorates).
- Conflict resolution/management skills.
- Strong networking and relationship building skills.
- Experience balancing multiple projects simultaneously.
- Ability to proficiently communicate both verbal and written in English required.
- This position will be located in Titusville, NJ, Raritan, NJ, or Spring House, PA, and may require up to 25% of domestic and/or international travel.
- 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)).
- This position is eligible to participate in the Company's long-term incentive program.
- Employees are eligible for the following time off benefits:
- 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
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on July 19, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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 .
