Johnson & Johnson Careers
QUALITY OPERATIONS DIRECTOR
Requisition ID: 1905749715W
Leads the overall management and effectiveness of the quality management system and provides overall direction to the quality function.
Plans, executes and manages the quality management system and activities including quality engineering, quality operations and laboratories, product release, quality systems, corrective and preventive action, non-conforming system, risk management processes, document control and training systems, ensuring compliance with regulatory and company requirements.
Under limited supervision with upper management direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Serves as the site Management Representative as defined in the Quality System Regulation and ISO 13485. Performs the duties of Management Representative as defined in the appropriate Quality Manual and governing procedures.
- Monitoring the quality management system as part of the Quality System Management Review and Quality Audit Program to ensure compliance all applicable regulations and standards.
- Reviewing performance of the process/system for the site at planned intervals to ensure suitability, adequacy, and effectiveness of the quality management system and to identify opportunities for improvement. Ensuring continuous process and product improvement.
- Ensuring the promotion of awareness of regulatory requirements throughout the organization. Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements.
- Defining the purpose and objectives of the quality system in the form of the quality policy and annual quality strategic plans, which are further developed into strategic goals and objectives. Has authority and responsibility to assure the goals supporting the objectives are attained including ensuring the availability of adequate resources in consideration of the yearly manufacture volumes and other needs for the quality system. Prioritize goals to achieve deadlines and the objective.
- Monitoring key quality performance measures and corrective action results. Responsible for the CAPA system and reporting on the results to management with executive responsibility; recommending and initiating corrective and/or preventive action as appropriate.
- Overall risk management planning, including ongoing review of the effectiveness of risk management activities ensuring that policies, procedures and practices are established and documented for analyzing, evaluating and controlling product risk throughout product realization.
- Ensures the analysis, evaluation, and presentation of information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products.
- Oversees the development of policies and procedures related to quality which affect operational and compliance status.
- Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
- Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
- Evaluates contents of reports on product assurance from department heads and confers with top management personnel in preparation to formulating a fiscal budget.
- Coordinates and oversees activities related to internal and supplier audits to assure compliance with company, state, federal, and international standards.
- Organizes, plans, leads and manages quality related projects in alignment with company goals.
- Monitors supplier quality related activities to assure fulfillment of contract/purchase order requirements.
- Facilitates the development and training of immediate staff.
- Prioritizes use of staff resources based on global project team input. Forecasts headcount and resource needs based on these priorities. Estimates and Oversees staff as part of overall quality budget responsibility.
- Develops the strategy, with tactical and operational plans for the quality function and ensures that tactical objectives are met in support of strategic targets.
- Oversees and leads quality investigations and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations.
- Oversees and ensures proper execution and compliance in complaint handling investigations performed by the site.
- Oversees the quality review resulting from statistical and data analyses for projects involving the design, development or validation of new or existing products and processes.
- Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
- Establishes and maintains global relationships with partnering organizations and regulatory bodies. Leads cross functional teams and provides subject matter expertise to other departments.
- Responsible for communicating business related issues or opportunities to next management level.
- 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.
- Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs).
- Performs other duties assigned as needed
- Minimum 10 years related experience in quality and regulatory functions.
- University/bachelor’s degree or equivalent. A combination of experience and education may be considered.
- Experience in the Medical Device industry or regulated medical field is required.
- Prior management experience is required.
- Six Sigma Green Belt or Black Belt is recommended.
- Based on education and/or experience, be able to provide appropriate technical input and review of product realization activities including but not limited to design control, validation, and production process controls, product release, and material controls.
- Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
- Advanced computer skills and use of software applications (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)
- Proficient in project management, creating credibility within team members and expanding capabilities of the group.
- Strong Organizational, interpersonal, oral and written communication, presentation skills.
- Ability to prioritize multiple commitments and support technical problem-solving duties.
- Ability to shift priorities according to changes in company/department needs and open to different ideas/approaches.
- ASQ membership, CQE or CQA certification is preferred.
- The primary location for the position is the Mentor site in Leiden Netherlands.
- This position is not intended to be performed remotely, although remote support may intermittently be performed.
- Travel is approximately 10% and may include domestic and international
- May have interactions with customers of J&J on an intermittent basis as part of customer feedback processes.
Mentor B.V. Legal Entity (8352)