Accountability Description

PLM processes and system

·          Designs, develops & implements lifecycle and change control business processes across global systems and functions to facilatae operational execution, compliantly and effectively

·          Ensures the voice of the customer is reflected in the process and PLM system design to establish end to end vision and value creation, globally.  Based on competing needs of the customer, define and prioritize process and system improvement projects to achieve the optimimal state for overall Product Lifecycle Management.

·          Provides the business with adequate tools to perform lifecyle management and change control via compliant PLM system access, well-defined procedures, and an agile system in order to ensure quality and supply continuity.

·          Leverages business intelligence solutions and associated metrics to motivate change efforts across multiple disciplines.

Strategic Leadership

·          Develops the framework that ensures the ongoing optimization of the enterprise level value chain and its enabling capabilities.

·          Develops process maturity road map to deliver sustained business benefits, both system and process.

·          Influences and actively secures buy-in from functional leadership and drives the process users to embed best practices in their processes.

·          Influences, gains trust, and credibility globally to establish and foster collaborative relationships within the work environment

·          Ensures a Super User network is consistently established cross site and provide oversight, mentoring, and development opportunities

·          Serves as main interface with IT, relevant Business Process Owners, & Operational Excellence team.

Lead Continuous Improvement

·          Diagnoses process and PLM system gaps, gains project mobilization by ensuring development of detailed business cases, leads priority alignment with relevant BPOs, and IT, and achieves budget alignment with senior leadership. 

·          Map business processes slated for improvement, both current and future state. Determine, document, and communicate the impact of process changes for the process users. 

·          Define target metrics and implements KPIs;  communicates actual performance and initiatives driving improvement to defined KPIs

·          Collaborate with IT, Super Users, key stakeholders, and business process owners ensure successful solution deployment of IT system enhancement via development and priorization business requirements related to PLM and linked systems, when applicable (e.g. GRIT, EBS), including review and approval of the PLM URS. 

• B.S. degree (in science, engineering or business), with related business discipline experience. M.B.A. or other advanced degree in business or social sciences is a plus
• Thorough experience with Oracle Agile PLM Agile is strongly preferred,
• Extensive experience with at least 5 years of experience in GSC
• Experience with leading cross functional teams in broad and complex environment that require leadership within a matrix organization
• In-depth understanding of the pharmaceutical/biotech industry with focus on Change Control, Artwork development, Lifecycle Management, and/or general Change Management
• Manufacturing experience and in-depth knowledge of GMPs.
• Experience working on projects using a variety of process redesign methods (such as business process re-engineering, value chain analysis, Lean Six Sigma or total quality management)
• Experience in Continuous Improvement, green or black belt is prefered
• Excellent process, analytical and negotiating expertise in a complex supply chain cGMP environment.
• Clear understanding of process management maturity models and compliance.
• Ability to drive cross-functional meetings/projects, and excellent communication skills to present to Senior leadership.
• Investigate future technical capability potentials from Agile PLM system  in IT Dev environment
• Strong cultural and business acumen in international setting strongly preferred
• Strong oral and written communication skills, including presentation skills and ability to effectively work across complex environment, both vertically and horizontally
• More interested in business results than personal preferences, and in group rather than individual achievement
• Ability to work within high-performing virtual teams and highly collaborative
• Builds excellent relationships with key internal and external customers based on trust and confidence
• Fluent in English

This role is responsible for overseeing the Product Lifecycle Management (PLM) system and related processes, liaising with IT, and ensuring the system is aligned with and adequately supports the business for lifecycle and change management to drive operational excellence. The BPO must be able to bridge the IT and business domains and communicate between each side to generate effective business requirements and drive process/systems improvement and user adoption. The PLM BPO is a ‘change agent’ who demonstrates critical thinking. 

Agile and effective business processes are required to ensure end-to-end manufacturing, supply chain operations, and lean product lifecycle management.   The Product Lifecycle Management (PLM) Business Process Owner (BPO) oversees and optimizes the lifecycle and change control processes, and related sub-processes globally and end-to-end across functions, including both internal and external considerations, e.g. Partners, CMOs.  The PLM BPO follows business process management (BPM) principles to increase efficiency and maturity of processes, while ensuring cGXP compliance and capabilities to meet the needs of the business.

The PLM BPO defines the lifecycle and change management processes and, in conjunction with IT, owns the PLM roadmap, prioritizes projects to ensure the process and system can be used effectively and compliantly.  The PLM BPO leads global process harmonization, partnering with business process owners and leads across multiple global functions, such as Regulatory Information Management, Artwork Management, Serialization, Documentation Management, Master Data Management, etc., to drive process and system improvements, while ensuring data integrity and connectivity with associated IT systems.