Would you like to work for a Global Generics and Biosimilar company and contribute to our mission to extend and improve people’s lives? Join Sandoz!
Your responsibilities include, but are not limited to:
1.Lead the development of a consistent Quality Culture with high awareness on data integrity and close collaboration with GLS Country business partners and ensure a state-of-the-art Country Quality Organization is in place to best support overall business strategy.
2.Establish effective Quality oversight and ensure compliant GxP processes are implemented in the GLS cluster (namely for product availability in compliance with Marketing Authorization, effective change control management, effective complaint and incident management, effective risk assessment, effective Quality oversight for clinical studies and pharmacovigilance processes).
3.Act as the company key point of contact for Health Authority Field Alert and drug shortage reporting for pharmaceutical products and thereby provide a link between supplying sites and the agency.
4.Establish regular review and assessment of KQIs at the GLS Quality Committee and Executive Committees, ensuring close follow-up, control and compliance.
5.Ensure adequate Escalation across the Cluster organization and support effective and timely resolution of any GxP incident.
6.Prevent any potential compliance gaps and risks and ensure CAPAs will be ad-dressed.
7.Collaborate and work in good intelligence with the Hubs/ CoEs (like Export Market hub, QMS hub, training CoE…) to ensure Compliance and efficiency.
8.Deliver successful GxP regulatory inspections and internal audits of the GLS Organization.
9.Ensure that proper Quality oversight is implemented within the Cluster for 3rd parties/vendors/outsourced activities.
10.Ensure timely delivery of all quality services, and ensure all aspects of team activities comply with cGxP, legal, regulatory requirements and Novartis Quali-ty Manual and Policies.
11.Ensure that processes are in place to communicate any country specific requirements to both Region (external engagement) and headquarter level for all for GxP areas.
12.Ensure remediation activities all existing gaps, to ensure ongoing compliance.
13.Identify opportunities for continuous improvement identified and the punctual implementation of the annual Quality Plan implemented at Country level.
14.Attract and develop talents in the local Quality department supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the team.
15.Ensure appropriate Quality budget’s management across in compliance with Company target, identifying Risks and Opportunities.
Commitment to Diversity & Inclusion:
Minimum requirements
Languages:
Fluency in English and local language (oral and written), additional language(s) a plus.
Experience/Professional requirement: > 12 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
Technical Knowledge/ Competencies/Experiences • Expert understanding of GxP regulations from major Health Authorities
Leadership Behaviors/ Competencies • Demonstrated ability to build trusting relationships with senior management and other business stakeholders. Demonstrated business acumen and ability to identify stakeholders needs and adapt communications style.
Korn Ferry Competency Model:
Business Insight*, Courage*, Decision Quality*, Organizational Savvy, Strategic Mindset, Plans and Aligns, Interpersonal Savvy, Values Differences, Manages Ambiguity, Builds Effective Teams
Division
Business Unit
Country
Work Location
Company/Legal Entity
Functional Area
Job Type
Employment Type
Shift Work
Early Talent
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