Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Establishes and maintains quality assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
• Responsibilities over quality issues at all departments (including but not limited to Production, packaging, supply chain, QC Laboratory, and Omrix NV).
• Responsibilities over all QA release activities.
• Supervises the work of team members in regards to compiling and creating the documentation that accompanies batch release, approving shipments for final release to market and maintaining compliance with post marketing requests.
• Overall responsibility for quality aspects of the facility, systems, equipment, validation, engineering and maintenance aspects.
• Assures continuous quality control by following trends, maintaining annual product stability program and annual reports.
• Ensures appropriate oversight of all supply, storage and shipping activities.
• Review and Approval of SOPs, worksheets and forms related to products and processes, including Omrix NV.
• Supervises the team in conducting relevant deviation and complaint investigations if needed.
• Review and approves change controls, NCs (non conformances) and CAPAs (corrective and preventive actions), as applicable.
• Training and development of team members
• Representing the plant during quality audits and Health Authority interactions relating to post-market commitments and safety related submissions and inquiries for Omrix medicinal products.
• Tracks and reports on metrics used to maximize efficiency and productivity of the functional business work groups.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for communicating business related issues or opportunities to next management level
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
• Drive people leadership agenda, seeking for team growth and development and driving high performance teams based on our Credo and the Leadership imperatives values
• Deep understanding of HR employees' life cycle business processes and policies
• Act in compliance with Israel labor law regulation, J&J values and code of conduct
• Drive business operation excellence according to JJPS/JJOS methodology
• Budget management and Financial planning
• Strong JJSC business acumen to enable and advance business strategy execution
• BS degree in Business, Life Science, Physical Science, Engineering or other related field required.
• Minimum of 4 years of experience in compliance or quality in a regulated (FDA) environment.
• Experience in the Medical Device industry or medical field
• Experience in people management – preferred
• Experience in biopharmaceutical manufacturing is required, experience with combination products is preferred.
• Experience in handling patient/customer complaints, inquiries or servicing issues preferred
• Experience interacting with FDA, EMA and other regulatory agencies preferred
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
• Experience or proven record motivating leading and developing staff, in a highly changing environment.
• Demonstrating fortitude to make Quality calls.
• Working through multiple set-backs and unforeseen challenges.
• Six Sigma, Quality Engineer, Quality Auditor and/or Quality Manager Certification
• Knowledge of regulations in relevant markets.
• Build strong cross functional partnership, interfaces and communication
• Lead in a matrix organization
• Establish a diverse and inclusive work environment and culture