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Animal Health Global Product Steward

Prince Edward Island BioAlliance

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Location: Charlottetown, CANADA - PRINCE EDWARD ISLAND Posted Date: 4/24/2013 Position Type: Full time Job Code: Global Product Steward Required Education: Masters Degree

Description

Job Purpose
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.

Major Accountabilities
• Maintains overview of product(s’) process performance across sites and value chain, thru data trending, from raw materials to finished pack, to ensure process(es) are in control and capable
• Defines continuous improvement plans and keeps oversights of its execution (technical lifecycle management).
• Ensures products’ processes are in 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.
• Support product recalls.
• 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 for brand 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.

Dimensions of the Job
Number of staff reporting
• Direct: 4 Functional: 4-15
Financial responsibility
(Budget, Cost, Sales, etc.)
• Technical responsibility for products, end to end throughout
the supply chain and across multiple sites. Overall annual
project budget of up to $USD 10mi.
Impact on the organization
• Major impact to ensure business continuity, supply quality
of the product(s) of responsibility

Requirements

Ideal Background
Education (minimum/desirable):
• MSc. in Chemistry, Pharmacy, Chemical Engineering or
Pharmaceutical Technology. Desirable PhD in the above or
equivalent.

Languages
• Fluent in English. Desirable German or French or Italian.

Relevant Experiences
• 10 years experience in manufacturing/ manufacturing science and technology/technical development/Quality.
• Thorough understanding of product 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
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