Senior Global Process Owner

Job Description Summary

Locations: Dublin, Ireland; Westworks, London, UK; Hyderabad
Hybrid, #LI-Hybrid
Thins is an opportunity to join our Strategy Program and Portfolio Operations team, and specifically our Process Excellence team, to work in the development
and be accountable for designing and managing an end-to-end business process that is compliant with regulatory requirements and is fulfilling business needs across the end-to-end trial process in Development.
The Senior Global Process Owner will be responsible for overall governance and oversight of a process by setting appropriate strategy, coordinating process mapping activities, overseeing the development the various procedural documents related to a process, ensuring efficiency and effectiveness of the process and managing risks.
In addition, the Sr GPO would also be responsible to monitor process performance via KPIs/KQIs aligned with regulatory and organizational strategies. Possible areas of focus: clinical trial design / protocol creation, clinical development plan, IB process, clinical site management, clinical study report production.

Job Description

Your responsibilities and the requirements in the role are as follows:

• Accountability for the end-to-end delivery, maintenance and improvement of the designated process(es).

• Act as point of contact for the Quality System Owner (QSO) for any process related queries or tasks, as well as for the Line Function Representative.

• Play a leading role in the designing and management of streamlined processes within functional and cross-functional settings.

• Coordinates process mapping activities executed by Business Process Excellence Experts

• Ensure oversight of the controlled documents e.g., Standard Operating Procedures (SOPs) and Working Practices (WPs) of the designated process.

• Act as point of contact for the author (Lead SMEs) of controlled documents to ensure consistent document lifecycle management within a process.

• Provide guidance to authoring teams on the content of a procedural document with respect to the process.

• Ensure coherence between the various activities surrounding a defined process and its controlled documents through robust checks and controls so that they are compliant with regulatory requirements

• Drive harmonization and simplification of process across different controlled documents within the process

• Support QSO in monitoring and analyzing the impact regulatory changes related to the owned procedures (including digitization of the QMS).

• Monitor and analyze the impact of other procedural (SOP/WP/User Manuals/WPs, etc.) changes on own procedures

• Lead cross-functional process improvement & change management activities to optimize and help bring consistency in way of working and to strengthen overall operations.

• Ensure new and transformed business processes and activities are aligned and can be delivered globally and functionally by the responsible parties e.g., Global Line Functions

• You will provide valuable input into training strategy of the process, through close collaboration with Training Lead(s) Design, develop and maintain metrics in collaboration with Global Line Functions, Compliance & Quality, when relevant Monitor Key Performance Indicators (KPI) and Key Quality Indicators (KQI), when relevant and assess deviation trends SPOC for audits and inspections as relevant and based on scope of audit/inspection (e.g., if the scope is on an entire process).

• Responsible for oversight and management of risks related to the designated process.

• Participate in Annual QS review under the direction of the QSO. 

• Conduct root cause analyses and/or failure mode effect analyses (FMEA) as applicable and develop CAPA in alignment with Author (Lead SME), as required

• Develop CAPAs and measure CAPA effectiveness for deviations/quality incidents, audit and inspection findings pertaining to the owned process.

Key performance indicators:

• Processes supporting the achievement of Development Objectives

• Reduced number of process deviations / quality events / Audit & Inspection observations

• Increased productivity in terms of FTE savings

Minimum Requirements:

• University degree in Life Science, quantitative science or business. Desirable qualifications in shared services, outsourcing, global sourcing. project management/Coaching, 6-Sigma, Lean education/training, Master of Business Administration or equivalent

Work Experience:

• Extensive knowledge of end-to-end processes within clinical development, including supporting systems, regulations, and awareness of business changes. Desirable areas of expertise:  clinical trial design / protocol creation, clinical development plan, IB process, clinical site management, clinical study report production.

• Ability to anticipate and assess the impact of external and internal changes on the end-to-end process, supporting systems (and vice-versa), and associated training requirements.

• Experience in defining metrics to effectively monitor and improve processes.

• Clinical Development or Clinical Operations experience is desirable, with a foundational understanding of the clinical trial lifecycle.

• Strategic thinker with the ability to contribute to long-term process improvements and operational planning.

• Experience with process simplification and optimization, including improvements to quality documentation.

• Demonstrated ability to collaborate effectively across functions, supporting performance improvements within the end-to-end clinical development value chain.

Skills:

• Managing complexity – Business insight – Decision quality – Balances stakeholders – Global perspective – Cultivates innovation – Strategic mindset – Plans and aligns – Optimizes work processes – Collaborates – Builds network – Drives vision and purpose – Manages ambiguity

Languages :

• English.

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring