Global Compliance Manager

Novartis Animal Health is a world leader in the development of animal health products that meet the needs of pet owners, farmers and veterinarians. Our products are brought to life by diverse, talented, high-performing employees who are committed to saving, prolonging and improving animal lives.

At Novartis Animal Health, our focus is clear, our purpose defined.

Think What’s Possible.Manages compliance activities for area of responsibility (Development, Pharmacovigilance, or Commercial) by assuring compliance to Novartis Quality standards; develops adequate commu-nication, manages product and/or site compliance issues, and provides assistance to sites, coun-try business units, and organizations to assure overall success in regulatory compliance.1. Coordinate, globally, all compliance activities for area of responsibility (Development, Phar-macovigilance, or Commercial Operations). Assure that adequate resources are available at the scheduled time to service the business needs in these areas. Develop in depth under-standing of compliance and business requirements, workload peaks, and planning processes to assure the appropriate alignment. 2. Maintains assignment plans for global workload. Communicates and coordinates with other Quality groups to assure activities are completed. Develops annual audit schedules. 3. Develop Compliance Upgrade programs for key areas to achieve and assure continued com-pliance to Novartis Quality Manual. Provide auditing, risk assessment, and project organiza-tion and planning support to ensure CIP program establishment. 4. Coordinate all auditing activities globally for area of responsibility to assure that required sur-veillance of NAH operations, 3rd parties, clinical research organizations, and BD&L activities are sufficiently covered. 5. Conduct audits as assigned. Establish communication and reporting mechanism to assure adequate decisions and management attention is appropriately directed.6. Coordinate preparation activities of regulatory authority inspections to assure that organiza-tions are prepared and supported for the inspection. Provide input and oversight to assure that audit responses are appropriately made to the regulatory authorities.7. Provides input to quality policy and regulatory interpretation. 8. Provides current compliance education for area of responsibility.9. Provides Quality Assurance function for R&D both clinical and technical to assure that all re-quired documentation, rationale, scientific justification, raw data is available, accurate, and authentic.10. Provides Quality Assurance/e-Compliance validation oversight and support for assigned GXP computerized systems and equipment. 11. Performs other duties as assigned.QualificationsBachelor degree in science, engineering, or related field. 10+ years in regulated industry.Expert knowledge in one of the following: GLP, GCP or GMP compliance in one or more global regulatory requirements (FDA, MHRA, EMEA, etc)Working knowledge in all areas of compliance in one or more global regulatory requirements.Working technical knowledge in one or more of the following fields: sterile product manufacturing, solid dose manufacturing, analytical chemistry, facilities and equipment engineering, biologics manufacturing, microbiology, computer compliance; and/or working analytical technical knowledge of the clinical laboratory field. Direct experience with regulatory agencies.Knowledge of PC tools including word-processing (Word), spreadsheets (Excel), presentation software (PowerPoint) and Internet navigation.Knowledge of business process and the ability to work within the general business hierarchy.Ability to negotiate favorable outcomes while maintaining positive working relationship.Skilled in risk assessment methodologies, and project organization.Able to interpret regulations and policies, and to communicate and respond to associated questions.Ability to define problems, collect and review data, establish facts and draw valid conclusions.Ability to effectively communicate verbally and in writing.Strong leadership skills. Ability to effectively work with teams.Strong analytical skills. Ability to set priorities and manage multiple tasks.BenefitsCompetitive Benefits
Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here