Janssen a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, GCDO Business Process Ownership (BPO) . Janssen Research & Development, discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. The Director, GCDO Business Process Ownership (BPO) will be the single point of accountability within GCDO for the assigned processes within the value stream, responsible for the strategy, oversight, health and performance of those assigned processes and associated systems. This role will establish and maintain key partnerships across GCDO to ensure an integrated approach to process improvements and knowledge management/training in support of a learning culture. The BPO Lead will be a key member of the Business Process Ownership community of practice (CoP) and will be responsible for driving alignment of process performance assessment and continuous improvement best practices with other BPO Leads. The BPO Lead will also serve as the Global CAPA Champion or the single point of contact for the local CAPA Champion and Subject Matter Experts (SMEs) to ensure visibility, alignment and connectivity of CAPAs with continuous improvement efforts. The role will be accountable for developing and maintaining metrics and KPIs for the assigned value stream processes and CAPA status and responsible for communicating these to appropriate GCDO SLT and Management forums. The Director, GCDO Business Process Ownership (BPO) is operating in the EBIS group within GCDO and as such is partnering and communicating effectively with EBIS stakeholders in sub-departments, such as Process Data Integration (PDI), vTMF COE, Technology Platform Operations (TPO), Operational Data Warehouse (ODW) and Integrated BI Services (IBIS). Additionally, he/she will partner closely with the GCDO SLT’s BPO executive sponsor of his/her assigned processes within the value stream as well as with appropriate BRQC stakeholders. Other responsibilities include:
With endorsement of GCDO SLT sponsor(s), develop and oversee the process strategy for assigned value stream, inclusive of continuous improvement, process health and optimization.
Establish strong relationships with critical business partners across GCDO and outside of GCDO (IT, BRQC, TA, C&G, etc.) to ensure alignment. Build strong relationship with BPO Lead peers and Subject Matter Experts for the assigned processes in the value stream.
Effectively communicate with sponsors, leadership and business partners within and outside of GCDO on process status and requirements for assigned value stream processes.
Network with internal and external experts to exchange learning, good practices and leverage industry benchmarking.
As appropriate, lead global project teams on key cross functional strategic improvement projects through specific SMEs and other partners.
Through membership of the Business Process Ownership CoP, collaborate with Business Process Ownership Leads across end-to-end value streams to ensure alignment for process performance assessment and continuous improvement best practices.
Responsible for ensuring approval of SOPs and process deviations within assigned value stream processes; Responsible for monitoring process deviation rates and subsequent process improvement actions.
Establish and monitor metrics and KPIs for the assigned processes within the value stream. Contribute to completion of BPO balanced scorecard and related discussions.
Deliver on the connectivity of systems and supporting technology associated with business processes in the value stream. Implement associated business rules and coordinate consistency of business rules with stakeholders and peers.
Provide relevant training and communication to GCDO members about process improvement initiatives on the value stream processes, where relevant, and provide coaching, depending on expertise and need of GCDO members.
Shape the continuous learning and knowledge management support structure for the process value stream.
Ensure timely and effective response to process gaps and inspection/audit findings, as well as self-identified issues and serve as CAPA Champion: Ensure timely identification of appropriate investigation owners (“IO”) from the GCDO functions; Shape and drive a “right first time” methodology with IOs during Root Cause Analysis (RCA) and CAPA development as needed. Lead critical and major investigations; Review draft CAPAs and ensure consistency and coherence across the end-to-end process; Ensure timely development and execution of all CAPA commitments and Effectiveness Checks; Partner with regional Q&C Managers and MAO SMEs in countries to assess global impact of local audit/inspection findings.
Leverage Voice of Customer data and metrics to identify and drive process improvement initiatives within the value stream in alignment with overall GCDO strategies.
Accountable for portfolio of improvement initiatives within the value stream, inclusive of evaluation, recommendations for prioritization and measurement. Builds business cases for key projects and investments.
Drive end to end optimization and continuous improvement of existing processes/systems/controls within the assigned value stream to ensure overall effectiveness, compliance, connectivity and user friendliness.
Lead effective planning, implementation and change management of initiatives to ensure consistency across processes and tools, and demonstrate a standard of excellence in delivery within the assigned value stream of processes.
Identify risk within the assigned value stream of processes, develop and implement appropriate and/or necessary actions with GCDO SMEs and key stakeholders.
Contribute as an active member of EBIS, and contribute to overall strategy development and implementation for the organization.
A Bachelor’ degree is required. Advanced degree is preferred (MA/MS/PhD/MBA).
A minimum of 10 years of progressive business experience with demonstrated involvement in Clinical Operations/Quality Operations with exposure to clinical development teams/processes (from PI-PIV through filing) is required.
Exposure to global compliance and Business Process Ownership (concept or aspects thereof, such as SOP, Training, CAPA, Process Improvement, Metrics, System and/or Technology knowledge and exposure) is required.
Strong leadership skills, including influencing and relationship management skills. Must be able to influence and resolve conflict across a broad range of global stakeholders is required.
Strong strategic thinking skills and ability to quickly analyze and structure problems is required.
Experience leading matrixed teams in different functions and in different countries is required.
Must be able to understand large complex processes with a focus on continuous improvement and a desire for prudent innovation is required.
Demonstrated knowledge of clinical research (end-to-end) processes and relevant regulatory requirements is preferred.
Strong project and portfolio management skills, and must be able to effectively manage multiple competing priorities is required.
Must be proactive and willing to challenge the status quo. Must adapt to a rapidly changing environment and must be able to manage change positively as an opportunity to improve processes and tools is required.
Knowledge of continuous improvement tools and application to business process is a plus.
Must be customer focused and able to lead process improvement initiatives from an internal lens of time, cost and quality and through an external lens of customers’ and stakeholder experience (investigators, patients, TA, other GCDO functions) is required.
Must be pragmatic in approach. Ability to demonstrate business acumen and openness to leveraging solutions from other areas of business, whether internal or external to GCDO is a plus.
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management