Specialist, QA Clinical Auditor

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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 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.

QA Clinical Auditor hybrid role to be located near J&J offices (ability to comply with J&J Flex).

As a Specialist QA Clinical Auditor you will:

• 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.

• Analyses 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.

Qualifications/Requirements:

• A minimum of a Bachelors degree is required. Advanced degree in scientific medical or related subject area is preferred.

• Experience working in Clinical Quality & Compliance Clinical Operations and/or related R&D area is required.

• 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.

• Must be able to speak and write in English.

• This position may require up to 30% of domestic and/or international travel.

Heres what you can expect:

• Application review:Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you:If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed:We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps:For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

• Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process!

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