Johnson & Johnson Carreiras
EXTERNAL MANUFACTURING COMPLIANCE MANAGER
Descrição da Vaga
Requisition ID: 3859190503
External Manufacturing Compliance Manager
Summary of responsibilities: Performs planned External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards, quality agreements, and to company policies and procedures. Provides EM compliance expertise to the organization as required.
Essential Duties and Responsibilities (Other duties may be assigned):
• Assures that the EM audit function complies with cGMP and other regulatory requirements.
• Performs audits of EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
• Performs EM audits of deficient matters and corrective actions, as needed and required.
• Documents EM audit results in written audit reports that are distributed and reviewed by appropriate management.
• Serves as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors.
• Maintains files containing reports of EM audits or re audits.
• Provides direction and guidance to auditors in training and/or volunteer auditors.
• Collects and reviews EM audit metrics and communicates to site and worldwide management. Generates data for management reviews.
• Assists in formulating EM procedures to be followed by the auditing group.
• Maintains abreast of global regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
• Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Education and/or Experience: BS in a related science or engineering field of study;
- 8+ years of related experience and/or training. Proven ability to conduct and manage audits required.
- Computer Systems Validation experience preferred.
- Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
Other Skills and Abilities:
- Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, and legal documents.
- Strong knowledge of quality and compliance in a regulated GxP environment is required.
- Understanding of all requirements for compliant manufacture, including facilities, equipment, documentation, testing, and product flow is preferred.
- Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up is preferred.
- Knowledge of validation on computerized systems is required. Ability to select, manage and direct a team during an audit.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community. Strong statistical skills and manufacturing process understanding.
- Ability to effectively present information to top management. Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
- Ability to stand firm while being open to new approaches. Ability to build partnerships both internally and externally.
- This candidate will have proven experience driving progress and remaining focused under ambiguous and complex situations.
- The ability to take in the vital points of the audit and make big picture decisions and observations is required.
- In addition, this candidate will have strong consultant and leadership skills, while still being a team player and working well with others. Ability to effectively interface with governmental and independent auditors Ability to use PC's and associated Microsoft software.
The position will require approximately 50% travel both domestically and internationally.
Location: This position will be based at São José dos Campos, Brazil
Brasil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154
J&J Brazil (7680)