Primary Role
* The Knowledge Management (KM) Lead is responsible for developing and overseeing the Pharmaceutical Development (PD) Department CMC Knowledge Management strategy and execution to facilitate knowledge capture (data and documents), sharing and archiving.
Develop and oversee a comprehensive integrated KM strategy for pharmaceutical product knowledge which facilitates data capture, document management, knowledge sharing and collaborations across the pharmaceutical development spectrum. Align with Corporate, Legal, Regulatory and Operational mandates for data/document retention.
* This will include standard and novel approaches to capture data from multiple internal and external sources. Identify and seek out opportunities to better leverage captured knowledge across the product life-cycle to enable information and knowledge to grow, flow and create value. Develop a culture of integrated KM that engages people, platforms and business processes that facilitates effortless information flow.
Ensure visibility and alignment with Technical Operations, Quality, Regulatory, Commercial Manufacturing, IT, Records and Information Management (RIM) and other potential cross functional stakeholders.
* Following asset acquisitions, mergers, divestments and site transitions announcements work to ensure the integrity of the pharmaceutical product data and documents (structured, unstructured, system/application and physical records) is safeguarded and full pharmaceutical product knowledge transfer occurs in a timely fashion.
Additionally, when required, the Director supervises and coaches junior staff and supports the department with continuous improvement activities
Responsibilities
35% Knowledge Management Strategy
* Creation and oversight of a strategy, principles and roadmap for pharmaceutical product knowledge management. Identify and understand user's needs and priorities, evaluate existing resources, systems, external vendors and potential partners.
* In collaboration with cross functional stakeholders ensure existing enterprise-wide technology is thoroughly investigated and fully deployed to support functional groups by integration of information systems, exploring expanded tool optimization through in house expertise or external partnerships, leverage of systems situated across departments to increase flow of knowledge, maximize data mining services to allow analysis of results, data visualization, and trend analysis where appropriate.
* Where new or innovative tools are identified to increase productivity or value work with business owners to lead business case creation and approval and secure necessary resources to support strategic vision.
* Collaborate with IT to explore and implement technology and information tools and platforms to provide KM services where necessary.
* In relation to KM compliance; acts as the SME for pharmaceutical development in data integrity, CSV, GAMP, GxP assessment as it relates to information management systems used by the department
35% Knowledge Management Execution
* Actively manages the delivery of established knowledge management systems and processes to service the department. Understand the advantages and constraints of existing technologies and systems
* Actively manages the development, delivery, training and implementation of any future selected systems and strategies for the department
* Develop business capabilities and support model for sustaining the flow of knowledge, establishing, maintaining and demonstrating the connection to improved business outcomes
* Seek regular customer feedback for evaluation and enhancement of the KM lifecycle
20% Integration Lead
* Following asset acquisition provides oversight and management of pharmaceutical product knowledge transfer.
* Works closely with pharmaceutical development teams to identify information need and ensure deliverables are met in line with products goals. Actively prioritizes KM activities.
* Works actively with IT business leads to identify and deploy automated and GxP compliant knowledge transfer where feasible.
* Quickly and proactively develops relationships and acts as the conduit from transferee to receiver functions at Shire.
* Ensures essential transferee data /document storage locations are identified and safeguarded to assure business continuity (includes structured, unstructured, system/application, electronic and paper locations)
* Leads, participates and actively contributes to functional knowledge integration discussions.
* Provides project management capabilities for more complex integrations
* Uses experience, feedback and evaluations to develop and maintain sustainable business model for future integrations
* Provide regular and comprehensive updates to senior management, identifying opportunities, constraints and needs.
10% General
* Mentors and coaches junior staff within the department.
* Assists in the development and implementation of departmental processes, procedures and policies.
* Maintains a high level of professional expertise through familiarity with regulations, scientific literature and participation in training courses.
* Attends relevant internal training courses and is responsible for implementation of systems within the department.
Education & Experience Requirements
* Bachelor's degree (or higher)
* Minimum 15 years' experience in the Pharmaceutical Industry or related IT, Quality, Compliance or Regulatory field. Familiarity with the objectives and processes across multi-disciplinary functions involved in drug development, registration and quality (GxPs) is essential
* Proven working knowledge of global GMP and ICH guidelines and regulatory requirements. Specifically Internation¬al Conference on Harmonization (ICH) guidelines which establish the paradigm for Quality by Design and develop¬ment and manufacture of drug substances, specifically ICH Q8 (R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality Sys¬tem, and ICH Q11 Development and Manufacture of Drug Substances is essential
* Proven experience in leading successful change management projects is essential
* Experience of small molecule and biologic manufacture through outsourcing and insourcing models is essential.
* Strong knowledge and hands on experience with multiple IT solutions commonly used in the industry for data capture and utilization is required
* Strong working knowledge of GxP, GAMP, CSV and data integrity principles is required
* Knowledge and/or application of pharmaceutical development, technology/product transfer, commercial manufacturing is desirable
* Operational Excellence knowledge is desirable
* Strong knowledge of Quality Systems; CAPA, Change Control and Deviation principles is desirable
* Proven experience in an information management role providing data analytics capability and system suitability assessments is desired
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application proces
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