Director Validation - (Job Number: 0711637)

US-CA-Silicon Valley/Peninsula Status: Full Time, Employee Job Category: Quality Assurance/Safety Reference Code: 665284 Director Validation - (Job Number: 0711637) DescriptionConor Medsystems, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Validation, located in Menlo Park, CA.The Director of Validation will design, develop, implement, maintain and oversee the validation and calibration programs related to facilities, processes, equipment and automated systems and software at Conor. Manage the validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory requirements and Company requirements.Serve as the spoke person and Subject Matter Expert in all areas of validation providing guidance and oversight from the quality perspective on all validation and calibration activities. Major duties and primary responsibilities will be as follows; Manage and oversee the company-wide validation and calibration programs and provide guidance and expertise to project teams for all validations. Further develop and continuously improve the validation and calibration program to enhance effectiveness, efficiency and compliance. Oversee the facilities, utilities and equipment qualification and validation for the newly planned Class 10,000/100,000 clean environments. Participate in the evaluation and hiring of any third party contractors and consultants for carrying out validation activities. Serve as the validation expert on the team and provide validation oversight and guidance for any Quality System related automated system implementation, i.e., LIMS, Document Management System, etc. Establish and ensure the rigor of testings performed during all qualification/validation activities to be consistent with regulatory requirements and industry standards. Ensure appropriate resolution and documented justification for any and all deviations encountered during validation activities. Responsible for communicating and elevating critical business related issues as well as opportunities to Senior Management. Oversee the calibration program and appropriate escalation and resolution of any Out of Trend results. Collaborate with R&D during process validation activities and technology transfer as appropriate. Manage the calibration and validation staff including hiring, training, and performance management. Provide support in the resolution of product complaints, product problems, or safety issues. Plan, promote and organize required training activities related to different validation areas. Maintain up to date knowledge of the industry and regulatory trends related to all aspects of validation as well as knowledge on company products and process technologies. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures for Class III medical devices. 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. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations/MDD/ISO and other regulatory requirements. Bachelor's degree in an appropriate science or engineering discipline with a minimum of 10-12 years of production, quality assurance/quality system experience is required. A minimum of 7 years validation experience with medical devices or combination products are required. A minimum of 5-7 years management experience required. Excellent written and verbal communication skills and presentation skills are a must. Ability to work across multi-functional teams as well as contractors/consultants is required. Excellent problem solving and negotiation skills are required.If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now