Summary
This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific responsibilities of the position -Management TrackLead and manage the Engineering, Logistics and Safety Experts team inthe Local Supply Center to ensure deliveries of intermediates anddrug substance, maintaining compliance with internal and externalregulatory and quality standards(GMP and HSE) and budget targets.Responsible for maintenance and investment budgets and long terminvestment plan for DSS.TRD Representative for Engineering for Rhinetal Valley. -Scientific / Technical TrackHas operational end to end responsibility for assigned supply activities. Leads and manages complex and demanding projects and global network activities and participates in cross-functional teams. Accountable for performance improvement initiatives. -Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). -To oversee clinical supply on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.
About The Role
Role Purpose:
Leads a team of Clinical Label Managers (CLM) and is accountable for operational deliverables as well as owns functional end-to-end responsibility for the team in a direct leadership role.Drives functional excellence. Fosters a culture of empowerment, trust, learning, diversity & inclusion and high performance and has the disciplinary and legal responsibility for the people assigned to own team.
Major Accountabilities
- Ensures high standards in all people processes including objective setting, development planning, performance management and overall talent management. Identifies and hires the appropriate talent in line with business needs
- Is responsible for robust resource planning for CLM portfolio/projects and special assignments. Assign the appropriate CLM(s) to the project, considering the complexities and individual expertise, capabilities and resource availabilities within team.
- Has operational accountability to make sure that CLM deliverables are met for the trials in CLM portfolio/projects as per agreed timelines, budget, quality and compliance standards. Ensures operational discipline within own team with full adherence to the Global Clinical Supply (GCS) planning rhythm
- Foster continuous improvement of processes to maintain high quality standards and operational excellence. Ensures best practice sharing, knowledge exchange, and cross-functional support within the team and with other stakeholders in GCS. Adapts priorities in response to changing needs.
- Ensures compliance to all relevant standards (e.g. HSE, GMP, ISEC, Data Integrity, Data Privacy). All deliverables should comply with all relevant corporate and legal guidelines on HSE and quality requirements. Supports internal and external audits and inspections
- Effectively manages the interface between the team and stakeholders in other functions in and outside of GCS. Acts with credibility and clarity of purpose to build and maintain effective relationships with important stakeholders.
- Act as first line of escalation for all operational challenges
- Achieves a true culture of collaboration with courage, empowerment and innovation, diversity and inclusion, trust, high performance and continuous improvement mind-set in the team
- Executes individual activities, part of the CLM main activities & accountabilities, as needed.
Key Performance Indicators
Minimum Requirements:
Work Experience
- > 12 years of practical experience in the chemical or pharmaceutical industry, along with 8 to 10 years of direct people management experience.
- Should have direct experience working with global teams across geographies ( lead projects & managing global stakeholders )- MNC exposure
- Excellent Communication and global stakeholder management is non negotiable
- Clinical or Commercial Labelling and Regulatory environment experience is essential
- Strong leadership skills demonstrated by projects delivered, operating ecosystem, complexities handled and frontline manager experience aligned with NVS V&Bs.
- Good expertise in related field.
- Good knowledge about the Drug Development process
- Basic project management , good organization and planning skills
- Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.
- Demonstrates problem-solving and idea generation skills
- Good presentation skills
- Intermediate Leadership skills
- Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
Skills
- Continual Improvement Process.
- Master Data.
- Material Requirements Planning (Mrp).
- Materials Management.
- People Management.
- Production Planning.
- Project Management.
- Supplier Relationship Management (Srm).
- Supply Chain Planning.
- Supply-Chain Management.
- Technical Requirements.
- Wms (Warehouse Management Systems).
Languages
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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