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

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DUTIES AND RESPONSIBILITIES

• Responsible for ensuring individual and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures, including ISO and any other regulations of the sites we supply.
• Be responsible for disseminating and ensuring adherence to policies, standards, and procedures in force within the company, as well as their alteration and updating when necessary.
• Responsible for maintaining procedures related to NC, CAPA, Record Management, and Document Change, in addition to providing support to users of these systems and proper understanding of the internal flows.
• Provide support on topics related to Failure Investigation (NC and CAPA), techniques, and statistical and managerial tools and lead all CAPA/NC related topics (CAPA/NC site lead).
• Responsible for maintaining the key metrics that support the local/global Dashboards.
• Responsible for conducting local Management Review, in addition to providing data to other involved sites’/franchises Management reviews.
• Ensure compliance with internal and legal standards related to company records and information by defining procedures, filing methods, document storage, and retention/validity periods.
• Ensure compliance with internal and global standards related to document control.
• Lead and/or participate in improvement projects, preparing and drafting management reports for monitoring and decision-making.
• Ensure the quality information system contains consistent and reliable data and indicators through proper monitoring and systematic control of regulatory standards and related documentation, critical analysis of impacts, and timely correction of deviations.
• Provide technical support to the production process regarding product characteristics and performance when requested.
• Properly evaluate quality processes by conducting and/or approving trend analysis, identifying gaps and improvement opportunities, and monitoring corrective and preventive actions.
• Responsible for communicating problems or opportunities related to the business to the next management level.
• Ensures the adoption, at all levels of J& J Medical Brazil, of a quality culture that enables meeting the objectives defined by the company, complying with applicable regulations and policies;
• Ensure subordinates follow all company guidelines related to Environmental, Health, and Safety practices, and that all resources needed are available and in good condition, if applicable.
• Develop the area’s Budget planning, as well as appropriately utilize the financial resources provided.
• Promote continuous improvement and/or achievement of quality objectives in company processes.
• Manages staff performance and takes disciplinary action when necessary.
• Empower team to act with speed, agility, and accountability.
• Position reporting to the Quality Director;
• Responsible for a team of 5-7 people;
• Responsible for managing the Quality System processes to ensure they comply with the company's requirements and site goals;
• Manage the department and the team by proposing solutions and identifying opportunities for improvement;
• Constantly interacts with other areas such as Manufacturing, Planning, Quality Operations and Supply Chain at a local level and with a high interface with global functions.

EXPERIENCE AND EDUCATION

• Bachelor's degree in Engineering, Administration, Pharmacy, Biology, or related fields, or proven experience in performing the activity;
• Master degree in Quality Engineering, People Management, Quality Management or related areas is desirable;
• A minimum of 6 years of Quality experience in a GMP and/or ISO regulated industry is required, with at least some of that time spent in a leadership position;
• Experience with Health Authorities and Audits;
• Experience in project management is desirable;
• Fluent in English is required

KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES, AND NECESSARY AFFILIATIONS

• Desired certification in Lean or Six Sigma (Green or Black Belt);
• Verbal and written communication skills;
• Skills in training/education methodologies;
• Knowledge of Regulatory Standards;
• Knowledge in problem-solving and quality tools;

LOCATION AND TRAVEL REQUIREMENTS

• Position based in São José dos Campos fully on site
• Occasional travel for domestic and/or international territories.