Work as TRD Quality Project Manager at Novartis
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : TRD Quality Project Manager
To implement global processes, governance, and tools for the Integrated Release (iRelease) Platform across all geographies and study types.
To manage iRelease enhancements that meet strategic objectives that support/facilitate global end to end release.
- Build, lead, represent, manage and support global cross-functional project team to refine and implement global processes, governance and tools.
- Act as system owner for iRelease platform in Global Clinical Supply work streams for the iCS (integrated Clinical Supply) landscape.
- Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
- Contribute to the strategy of assigned projects including contingency planning and risk assessments as appropriate to ensure timely achievement of project deliverables.
- Ensure that the strategy followed within the assigned projects is in line with TRD Business and QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
- Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
- Establish and/or support 3rd Party contractors for packaging, labeling and distribution (External Operations Management) if access and/or interface projects are required.
- Drive creation and implementation of audit/inspection CAPAs and act as a key con-tact for Global GCS compliance topics within TRD QA specific to iRelease related topics.
- Catalyze end to end cross functional collaboration for OneDevQA support and implementation.
- Ensures suitable composition of project team and regional implementation teams to support design and roll-out.
- Define and implement relevant KPIs for project progress and affected operations.
- Assists with TRD QA budget impact analysis based upon the introduction of new initiatives and requirements.
- Assess, consolidate and negotiate on an ongoing basis all internal and external re-source needs as well as times for iRelease system releases.
- Design system project plans to ensure all relevant tasks are captured with timeline, dependencies, and resource requirements defined.
- Support global TRD GCS projects and initiatives with both iRelease support and business acumen.
- Participate in recruitment of talent and establish and perform training as mentor.
Undergraduate degree in science or relevant discipline. Desirable: Post graduate degree in science or relevant discipline. Fluent English required (oral & written). Good skills in site (local) language desired (oral). Broad experience (approx. 10 years) in pharmaceutical industry. Demonstrated experience with project management and software applications. Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills. Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes. Microsoft Project experience is desirable.
Location : Hyderabad
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Quality
Job ID: 258126BR
Last Date: 15th February, 2019
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