Manager, Validation and Qualification

Job Description

The purpose of this position is to plan, conduct and direct one or more research or development projects (including qualification projects/equipment calibrations/non-conformance investigations) of major significance, which are highly difficult and complex in nature, necessitating the expert application of advanced knowledge in the field of ophthalmic medical devices, sciences, and/or technology.

• Originates and applies new and unique methods, procedures and designs.
• Supplies technical advice and counsel to other professionals and may represent the organization in outside discussions and technical forums.
• Generally works with wide latitude for action or decision.
• May direct the activities of senior technical professionals to accomplish objectives.
• Plans, conducts and provides technical direction to one or more projects of major importance and difficulty where the complexity of technical problems involved requires the broad application of advanced knowledge of ophthalmic devices
• Supplies technical advice and counsel to other professionals
• Manage the qualification/calibration program for the VC R&D site including but not limited to facility, processes, equipment, cleaning, and software systems.
• Manage the non-conformance investigation program for specific business areas at the VC R&D site
• Apply advanced principles, theories and concepts.
• Contribute to the development of new principles and concepts.
• Work under consultative direction toward predetermined long-range goals.
• Determines and pursues courses of action necessary to obtain desired results.
• Completed work is usually reviewed from a relatively long-range perspective for desired results.
• Serves as organization consultant and spokesperson on specialized projects or programs.
• Acts as advisor to top management on advanced technical research studies and applications.
• Design major components, or major portions of a functional system, or technically advanced prototype, or specific products for medical device/science/technology.
• Use analytical techniques and/or previous experience to identify the most appropriate option or to adapt or improve existing approaches.
• Provide advice or instructions on existing processes based on previous experience; interpret complex information for internal contacts and exchange factual information with external contacts; and make decisions impacting own scope of work
• Internal interaction requires interpretation of complex information and external interaction mainly requires exchange of factual information, audience may be outside own area and unfamiliar with subject.
• Apply advanced engineering principles to the research and development of medical device/science/technology and/or provide engineering expertise to support development.
• Assure continuity of products and processes assessment feasibility, research, design, development, compliance to customer and non-customer requirements, transfer to production.
• Provides general supervisory direction, determining and developing approach to solutions by coordinating multiple resources to solve complex problems.
• Lead design reviews, assign and review action items.
• Ensure regulatory / statutory / legislative compliance for all project work.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience with 3 Years of Demonstrated Leadership
• Multiple project management skills; department level scope.
• Demonstrated leadership capabilities.
• Strategic planning and implementation.
• Midsize organization management.
• Previous medical industry knowledge and exposure preferred
• Recognized in specialty field as an expert.
• Applies extensive depth and expertise as a generalist or specialist to major, complex technical issues.
• Work experience contributing to the formation of new principles and concepts for new product research and/or development.
• Proven ability to develop solutions for complex problems that is original, innovative, and leading edge.
• Interactions with senior personnel on complex matters.
• Expert knowledge of ISO, FDA, MDD and regulations applicable to the design and development of medical device/science/technology highly preferred.

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