Corporate QMS Manager (PET) " >Corporate QMS Manager (PET)

Oct 14, 2021

Job Description

Job Purpose:

To drive, execute and support effective and efficient processes related Quality Systems, other operational activities and QMS projects within responsibilities of the Corporate QMS team in alignment with regulatory, GxP and QMS requirements.

Major Activities:

• Drives and supports the lifecycle management of GxP documents and records (maintenance, storage, retention, archiving, disposition)
• Leads QMS transition project for the harmonization of corporate procedures within PET sites/entities
• Defines specific QMS needs and QMS strategy for PET sites/entities
• Ensure continuous QMS improvements by establishing and maintain best QMS practices for PET sites/entities
• Coordinates the projects for configuration and roll-out of QMS IT applications
• Ensures that a structured project management approach is applied, a detailed project plan is in place, including budget and human resources, and executed within the agreed timelines and defined scope
• Define and coordinate the cross-functional project teams.
• Maintain the oversight of the QMS related projects, perform regular and timely management reporting and lead the related steering committee(s).
• Interact with local and global teams/stakeholders including external contractors where required and ensure alignment and strong collaboration/co-ordination throughout the projects and routine activities

Key performance indicators:

• Ensuring compliance to the effective standards and procedures
• Efficient and timely management of operational activities
• Timely and in budget implementation of QMS Projects
• Successful roll out/implementation plan
• Successful inspections in relation to QMS topics/projects

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education: Graduate in Chemistry, Pharmacy, Microbiology or another related science

Languages: English fluent in speaking / writing. Other languages desirable

Experience / Professional requirements:
• 5-10 years’ experience in the pharmaceutical industry, preferably in FDA-regulated environment and in QA Operations and/or QA Compliance of a strategic site or a global role
• Strong project management skills
• Excellent management, interpersonal, communication, negotiation and problem-solving skills.
• Experience in working in a matrix environment
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
• Quality Assurance / cGMP regulations, especially for US and EU (Document and Record Management, Exception Handling, GMP Training, Change Control)
Full Time
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Corporate QMS Manager (PET)

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