Quality Systems and Compliance Audit Lead (Grecia, Costa Rica)

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 jnj.com.

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.

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Grecia, Costa Rica

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Senior Regulatory Compliance Specialist.

Purpose:

This role is part of our Regulatory Compliance team and will play a key role in leading the Internal Audit process, supporting audit readiness and driving compliance with Quality Management System and regulatory requirements.
We are looking for professionals with strong experience in Quality Systems, Regulatory Compliance, and internal/external audits within the medical device industry.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
• Conducts internal audits of the Quality System for the purpose of verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Conducts good laboratory practice (GLP) audits as required.
• Gives guidance or advice as it relates to compliance with applicable standards and regulations.
• Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.
• Assigns classifications to internal audit observations and documents audit results in written reports that can be distributed and reviewed by appropriate management.
• Monitors the effectiveness of corrective actions documented in observation responses.
• You can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or volunteer auditors.
• Reviews ownership of responses to audit observations, also acts as an advisor to other areas that are not being audited by him/her, giving advice on audit observation responses.
• Maintains audit report files, re-audit files and responses to audits carried out.
• Accompanies external auditors, representatives of government agencies or those required by management during the execution of an applicable audit.
• Conducts audits at other J&J sites when required by management.
• Complies with and reviews compliance metrics and communicates them to site management and the Franchise. Prepares information for Management review boards.
• Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable local, state and federal standards and regulations through the development of Franchise Documents.
• It is kept up to date on government regulations and applicable standard changes through publications, participation in seminars or by collaboration with organizations.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

Experience and education

• BS in science, engineering, or business.
• Minimum 4-6 years of experience in Quality, Regulatory Compliance, or related activities.
• Experience in Medical Devices field or in Pharmaceuticals (preferably).

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Effective communication skills – oral and written – (English and Spanish).
• Analytical skills to interpret scientific and technical publications and legal documents.
• Ability to select, manage and lead a team during an audit.
• Ability to respond to questions or complaints from clients, regulatory agencies or members of the
• business community.
• Skills to present information effectively to senior management, public groups and/or directors.
• Skills to work with mathematical concepts, such as probability and statistical inferences,
• fundamentals of geometry and trigonometry.
• Skills to interpret a variety of instructions presented in writing, verbally or graphically (diagrams and
• programs).
• Skills for the use of computers and associated systems (software).
• Skills to interact with auditors by the government and independents.
• Skills and knowledge of methods and techniques related to quality, including audit principles and
• techniques, quality terminology, quality management principles and their applications, as well as
• quality management tools and their applications.
• Knowledge in problem-solving techniques.
• Lead auditor certification preferred.

 

 

Required Skills:

 

 

Preferred Skills:

Audit and Compliance Trends, Audit Management, Audit Reporting, Business Behavior, Business Writing, Coaching, Communication, Compliance Frameworks, Compliance Management, Compliance Risk, Corporate Investigations, Critical Thinking, Legal Function, Legal Services, People Centricity, Problem Solving, Process Improvements