Position Title Global Product Steward

Job ID	125431BR
Division	Animal Health
Business Unit	Animal Health
Country	Canada
Work Location	Charlottetown
Company/Legal Entity	Animal Health Canada inc
Functional Area	Production
Job Type	Full Time
Employment Type	Regular
Job Description	Ensures oversight of product(s) related technical process(es) and quality aspects, end to end throughout the supply chain and across multiple sites, to maintain and improve product process cabability, quality and compliance. Maintains overview of products’ process performance across sites and value chain, through data trending, from raw materials to finished pack, to ensure processes are in control and capable Defines continuous improvement plans and keeps oversights of their execution (technical lifecycle management). Ensures products’ processes are in a constant state of validation end to end, across multiple sites, in liasion with the respective site MS&T functions. Reviews Annual Product Reviews (APRs)/Product Quality Reviews (PQRs). Liaise with site MS&T functions to develop overview of product process performance and to implement requirements at site level. Acts as primary contact person for complex technical problems Leads interdisciplinary teams for investigations. Liaises with other functions (e.g. Tech Dev, QA) to ensure complete and concise root cause investigation and resolution. Ensures support in resolution of technical and compliance issues, technical answers to QA, to internal inspection bodies or to Health Authorities. Ensures that technical customer complaints and deviations have robust CAPAs and that systematic issues are identified across sites and supply chain. Keeps oversight of Technical Change management to ensure consistency across value chain. Ensures timely evaluation and implementation of changes. Manages the relationship and set priorities with technical development organization & 3rd parties, assesses and challenges potential production processes, equipment etc., if suitable for commercial use Supports deployment of global quality initiatives (process trending, IRL, …) along the entire value chain. Keeps alignment with Supply Chain to ensure product supply. Initiates and oversees process improvements projects (for quality improvement & cost reduction), proactively interfacing with the relevant functions involved (e.g. Engineering, IT, Reg Affairs, CMC). Technical Transfer Supports Technical Development for technical transfer of new products from Development to Commercial scale within Novartis / to 3rd parties. Responsible for technical transfer of existing processes within Novartis / 3rd parties (incl. production configurations and set-up of supply chains with respect to flow of goods and fund’s flow). Proposes sites in line with the Manufacturing Footprint Strategy and Corporate Guidelines. Assists QA and Purchasing in agreements with 3rd parties to ensure appropriate establishment of MS&T principles. Project Management Lead interdisciplinary PST teams and set project priorities. Provides input to long term capacity planning (investments, divestments, project management) in accordance to the business needs Is member of TPT's, commercial PSTs, OLTs. Represents MS&T in various NAH meetings (stage gate reviews, BD&L committees, etc).
Minimum requirements	• MSc. in Microbiology, Chemistry, Bio/Pharmaceutical Technology or related field. Desirable PhD in the above or equivalent. •Fluent in English. Desirable German, French or Italian. • 10 years experience in manufacturing/ manufacturing science and technology/technical development/Quality. •Thorough understanding of production processes. •Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. •Fundamental understanding of standard pharmaceutical analytical testing. •Expert in reviewing and writing technical reports. •Strong project management skills, strong communication skills. •Reports: Direct: 4 Functional: 4-15 •Technical responsibility for products, end to end throughout the supply chain and across multiple sites. Overall annual project budget of up to $USD 10mi. •Major impact to ensure business continuity, supply quality of the product(s) of responsibility                                                                                                  Apply