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:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Remote (US), Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Senior Specialist, QA Clinical Auditor to be located anywhere in the USA, preferably near a J&J office. Remote work options will be considered on a case-by-case basis and if approved by the Company.

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

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 approaches that provide relevant insights to proactively secure compliance and drive sustainability and reliability across Johnson & Johnson Innovative Medicine.

Key responsibilities:

• Independently 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.

Education:

• A minimum of a Bachelor's degree is required.

Experience and Skills

Required:

• A minimum of 5 years of related work experience in auditing, clinical trial operations, or a related space
• 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 R3
• 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.

Preferred:

• 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.

Other:

• Must be able to speak and write in English.
• This position may require up to 30% of domestic and/or 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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.