At the Janssen Pharmaceuticals Companies of Johnson & Johnson, we are recruiting for a Manager, Quality Assurance (QA) Auditor to support GCP audits within the Clinical Domain, BioResearch Quality & Compliance (BRQC) Quality Assurance (QA) organization. This position will be located in the United States, with preference given to those sitting near a local J&J office.
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. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
Quality Assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, Marketing Authorization Holders, functions, processes and systems for JANSSEN Pharmaceutical Companies (and all partners) are in compliance with company standards and Health Authority guidelines and regulations. It is our mission to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry leading and by delivering innovative approaches to proactively secure compliance and drive sustainability and reliability across R&D. Main responsibilities will include, but are not limited to: Auditing
Independently leads the planning, conduct and reporting of assigned BioResearch GCP QA routine and 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 may include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
Assists in preparation and presentation of training materials. Supports the development and mentorship of other auditors.
Ensures the standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
Able to analyze, interpret data and identify 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 the writing of issued reports.
Supports regulatory inspections in lead or supporting role. Conducts pre-inspection visits.
Takes an active role in projects as assigned by supervisor
Subject Matter Expert / Point of Contact
Maintains good communication and provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures.
Interprets and applies regulations/ policies to issues of moderate complexity, when required.
Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)
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Bachelor's degree (or University equivalent) is required; Advanced degree in scientific, medical or related field preferred.
Minimum of 5 years of experience working in Clinical Quality & Compliance, Clinical Operations, and/or related R&D area is required
Experience using standard applications/systems & data analytics tools is required
Creative thinking relative to new and emerging technologies and analytics, and ability to find opportunities where creative capabilities may be applied within QA audit processes is required
Experience conducting Clinical Quality Assurance audits is preferred
Knowledge of the drug development process, GXP functional compliance regulations (national and international), sound research and development practices, scientific terminology, company quality assurance procedures and policies, and quality evaluation techniques is required
Understanding of fundamentals of clinical trial risk management is required
Inspection support experience (FDA, EMA and other inspectorates) is preferred
Have excellent networking, communication, organization, investigation, and negotiation skills is required
Ability to plan and prioritize work in an efficient manner and work well under time constraints is required
This position will be located in the United States, United Kingdom, France, Spain, Italy, Germany, Netherlands, Belgium, Poland, or Croatia, with preference given to those sitting near a local J&J office, and up to 30% domestic and international travel may be required
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.
Internal Number: 5207200519
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 130,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.