Business Process Document Manager

hace 1 semana

Barcelona, Barcelona, España AstraZeneca A tiempo completo
Clinical Operations within the Biopharma business unit is accountable for the delivery of clinical studies.


Process, Quality & Business Capability serve across AstraZeneca R&D (Research & Development), providing data-driven insights to inspection readiness, regulatory compliance, processes, and learning.

Listening to AZ and external Voice of the Customers, aligning to AZ goals, and removing the worry about our procedures, CAPAs (Corrective and Preventive Actions), Quality Issues whilst implementing major change initiatives.


Business Process Management & Optimisation delivers process excellence through a strong core capability partnering cross functionally to drive efficient continuous process improvements using lean methodology & data insight.

Resulting in optimised clinical study processes fit for the future.


The
Business Process Document Manager is a member of the Business Process Management and Optimisation (BPMO) Document Managers team, and is responsible for control, security, accessibility, development and timely delivery of process related documents for the clinical business processes owned by BPMO.


As part of this role Business Process Document Manager will be responsible for managing process "toolkits" and the maintenance and upkeep of the toolkit platform and contents as well as all communications regarding process updates supporting their business process areas.

It will include working closely with Document Management System team to ensure

that the processes/standards are adhered to and provide feedback to the Quality team following

issue analysis arising from the BPMO process management.


Role will act as a champion for process and document management excellence, and role model adherence to the business process framework.

As required, will act as a mentor for other BPMO colleagues in document management related areas.

As required, will work closely with IT team to facilitate the smooth operation of the document management system.


As part of this role additional responsibility can be assigned in relation to operational maintenance and administration of BPMO used tools in process management (ticketing system for process questions, R&D repository for process toolkits).


Business Document Management:

  • Develop and maintain process related documentation (mandatory, best practice and training) within an assigned subprocesses as per agreement with Business Process Owner
  • Maintain assigned process toolkit(s) and relevant tools (for example MS teams channels)
  • Manage process related questions in relevant process ticketing system
  • Participate and engage in process network or appropriate forums to encourage best practises
  • Participate and support improvement projects
  • Drive adherence to managing procedural documents process in daily work
  • Manage continuous improvement and change
  • Facilitate sharing of good practice and learning within function and cross functionally
  • Identify issues and risks, escalate as required through appropriate governance forums
  • Manage links with related processes

Essential

  • Bachelor's Degree in an appropriate discipline or equivalent experience
  • Experience in document management and document management systems
  • Good knowledge of ICH GCP, understanding of clinical trials
  • Proven ability of working with multiple documents on global level (creation, revision, maintenance) up to the standards
  • Change management
  • Demonstrated skills to deliver to time, cost, and quality
  • Proven ability being an end user of a process
  • Proven ability in communication both orally and in writing on a global level
  • Proven ability in presentation skills
  • Demonstrated ability in knowledge transfer (mentoring)
  • Collaboration and problem solving skills
  • Experience in working successfully and collaboratively within own team as well as crossfunctionally
  • Ability to work in a matrix environment
  • Ability to identify opportunities and to work across boundaries

Desirable

  • Experience within a pharmaceutical or clinical background
  • Experience as a process owner in clinical process management
  • Knowledge of business process management tools and lean methodologies
  • Experience of utilizing standard process improvement methodologies (e.g., Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
  • Demonstrated ability see change as an opportunity to improve performance and add value to the business

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