Support lab s equipment qualification program, both planning and execution.
Ensure the implementation and on-going monitoring of key performance indicators (KPIs) and key quality indicators (KQIs) that drive continuous improvements within the AS&T group.
Routinely assess testing monographs and proactively sustain compliance of all activities with current official regulations, pharmacopeias, QM, QD, GOP, and SOP.
Ensure processes and systems are in place and followed to allow effective analytical method transfers from Development to Commercial Manufacturing, and for site-to-site (including ESO or CPO retesting lab).
Liaise with internal partners, external supply organization (ESO), third party CMOs or external contract labs to evaluate 3rd parties for transfer readiness and capability, and provide oversight for transfer methods into site or out of site (incl. 3rd parties).
Establish a review lifecycle to maintain/develop/validate analytical methods. Ensure state-of-the-art analytical methods and enhanced analytical capabilities to support product quality and process understanding.
Evaluate and implement new technologies required to maintain state of the art analytical methods for development and marketed products. Develop a strategic mid-term to long-term investment plant to provide transparency of necessary equipment and support the sites in their investment decisions.
Provide statistical support for decision-making. Support investigations (OOS, complaints, forensic) when needed.
Liaise regularly and effectively with TRD Analytical Development groups to ensure that newly developed analytical methods are robust and effective in the commercial laboratory environment.
Provide support for troubleshooting and continuous improvement in the laboratory.
Provide life cycle management support for existing laboratory IT systems, applications and equipment.
Support Laboratory design and new setup. Participate in IT tools evaluation and validation.
Provide oversight for life cycle management of chemical components.
Carry out supervisory responsibilities including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; overseeing the development and maintenance of staff competence
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor's degree with at least 7 years of related experience (5 years of demonstrated leadership)
Must be fluent in English
Advanced degree in Analytical Chemistry, or related area, or equivalent experience.
Profound experience in Analytical Development and/or Quality Control functions at site and global level
7+ years of demonstrated leadership in local/global/matrix environment in pharmaceutical industry
Strong management, interpersonal, communication, negotiation, and problem-solving skills
Proven experience in people management and Strong project management skills
Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
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