TRD Quality Project Manager
Novartis AG
Hyderabad, AP, India
5d ago

Job Description Why Novartis :

927 million : The number of lives we touched in 2017.And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives.

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks.

And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Position Purpose :

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.

Major Accountabilities :

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.

Support transfer of business activities to India. Minimum requirements Minimum : 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.

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