346892BR
Jun 13, 2022
Switzerland

Job Description

365 days a year ! ChemsOps Switzerland work tirelessly on the launch of innovative APIs so that our products reach markets faster & in good quality thus ensuring our patients have the treatments they need to live longer, better and healthier lives.


As Site Quality Head for ChemOps you will provide managerial leadership for the site in all quality related matters and ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies.
You also be responsible for developing and leading the quality teams on site in line with the Novartis leadership framework and cultural aspirations.

Operational duties:

• Leadership of Site Quality organization
• Implement, comply with and govern practices prescribed in the Novartis Manufacturing Manual
• Quality oversight of GxP site functions
• Acts as site Technical Responsible Person (Qualified Person)
• Ensure product quality
• Ensure regulatory compliance and implementation of corporate quality standards and regulations
• Ensure status of local HA registration
• Preparation of Site Master File for regulatory purposes
• Site quality risk assessment
• Quality Management Review
• Approval or rejection of raw materials, facilities, utilities, preliminary, finished product or stability samples
• Approval of PQR/APQR
• Ensure exception management
• Ensure complaint investigation
• Ensure training execution across site
• Ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations
• Ensure adherence to HSE guidelines and requirements
• Collaboration in GxP internal audits
• Ensure fulfillment of internal/external audit and inspection plans
• Ensure any collaborations with 3rd parties are performed with adequate Quality Assurance Agreements in place
• Ensure any additional local legal requirements are fulfilled
• Ensure Business continuity management

Leadership & Culture

• Drive the talent agenda: Lead people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and quality unit competitiveness and diversity. Support a robust career path deployment and succession plan for the unit and site
• Invest time in personally developing and coaching talents
• Actively support and promote talent exchange for the benefit of the individuals and organization
• Ensure the consistency between career development processes and the business strategy
• Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates
• Ensure that associates are qualified for a GMP task prior to independent performance
• Monitor overall training compliance for in-scope associates
• Identify and maintain a list of subject matter experts for in-scope areas of expertise
• Create a work environment that enables high employee engagement
• Act as role model : Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for the success of our culture journey.

HSE

• Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
• Ensure overall inspection readiness for area of responsibility.
• Guarantee the effectiveness of the Business Continuity Plan
• Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.
• Responsible for participating in initial training and retraining
• Oversee HSE incidents reporting & action follow-up

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

• University degree in Chemistry, Biotechnology or equivalent
• Knowledge of GMP Quality Control (QC) Testing, Compliance, Manufacturing Process/Product Expertise
• Leadership and people management/ empowerment
• Fluent (oral and written) in English; preference for German speakers

Over 799 million! - that's how many lives we reached with our products in 2021. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to question the status quo, make courageous decisions and follow innovative paths.


Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO SMALL MOLECULES
Switzerland
Schweizerhalle
Quality
Full Time
Regular
No
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346892BR

Site Quality Head

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