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Job ID 320734BR Position Title Global Artwork Standards & Process excellence Manager Apply to Job AAA StatementAdvanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

Job Purpose:



The Global Artwork Standards & Process Excellence Manager is responsible for the defining of the standards, quality and compliance of the Global Artwork processes in accordance to internal and external requirements.

The role is responsible in identifying or defining best practices and embed process excellence in the artwork processes



Major Activities:



• Lead improvements related to the standards for the creation and maintenance of the global business process documentation, guidance documents, process flows, process descriptions, etc. to ensure compliance with business processes, GxP requirements, and use of tools, guaranteeing action for implementation and consistency between documents and processes;

• Strengthen compliance standards for global artwork business processes in collaboration with the Global Artwork team, coordinating involvement of local and global management and any other functions as needed;

• Leads the global artwork deviation network, supports cross-functional investigations and root cause analysis, identifies corrective and preventive actions (CAPA) to close gaps and eliminate risk of future reoccurrence (e.g. trainings, process updates, etc.); coordinates global change control activities and documentations relating to artwork. Participates in Change Review Board.

• Identifies, coordinates and supports global projects and initiatives for quality, compliance and process improvements of global artwork processes and implements/supports implementation of identified cross-functional actions;

• Acts as first escalation point and first point of contact for Global Artwork for artwork compliance and quality related matters;

• Performs compliance checks of creation and maintenance of the business process documentation (e.g. SOPs, business guidance documents, business process flows, process descriptions, etc.) and document management, ensuring all SOP and artwork documentation is regularly reviewed and updated to align with business requirements Document prepared by Global Artwork Strategy & Operations Lead;

• Supports on-site audits for the artwork process as Support Auditor for internal and external artwork departments and suppliers.

• Acts as point of contact relating to Quality agreements with suppliers and CMOs.



Excellence and compliance:

• Participate to global Cross-Functional Labelling & Artwork Governance Board to drive continuous process / quality improvements across functions and roles;

• Ensures strategic training alignment for artwork process related trainings with cross-functional partners (e.g. Regulatory Affairs (RA), Country Organisation QA, and roles within global and local Supply Chain functions), for auditors for the artwork process and provides artwork Process and Standards expertise for the auditing for the organisation.

• Leads lean six sigma projects relating to artwork processes

Minimum requirements

Education:



Bachelor’s Degree or equivalent related to business and/or quality control management. Further education in Operational Excellence (e.g. green belt) is considered a valuable asset



Languages:



Professional proficiency in both spoken and written English. French and Italian languages are considered a valuable asset.



Experience/Professional requirements:



• Minimum 5 years of Standardization and Compliance role in the fields of labelling/artwork for the pharmaceutical/biotechnology/life science industry including both development and commercial pharmaceutical products. Quality expertise related to production/manufacturing activities within the Radioligand framework, is considered as an asset.

• Proficient in Microsoft office package with deeper knowledge in Excel would be an asset as well as general knowledge on Power BI and reporting tool.

• Knowledge in Printing processes and systems.

• Strong formatting skills. Ability to work under appropriate supervision with extended, cross cultural project teams and deliver, under pressure of time and workload.

• Demonstrated verbal and written communication skills.

• High attention to detail, excellent capability to follow up projects through to completion.

• Effective planning, organizational and interpersonal skills.



• Process excellence skills such as Lean six sigma either as experience or by certification (e.g. green belt six sigma)



• Eager to learn and support in the improvement processes of the structure in a given tool, maintaining a high attention to standardization during the design / review / execution of activities among the applications.



Commitment to Diversity & Inclusion:

 

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

 

Join our Novartis Network:

 

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:talentnetwork.novartis.com/network Division Oncology Business Unit ADVANCED ACCELERATOR APPLICATIONS Location Switzerland Site Geneva Company/Legal Entity AAA International SA Functional Area Technical Operations Job Type Full Time Employment Type Regular Shift Work No

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