346034BR
May 26, 2022
China

Job Description

35 new drugs and indications approval were obtained in Novartis China between 2015 and 2021. In the next 5 years, Novartis plans include the submissions of 50 new drug applications to better meet the health needs of Chinese patients.

Provide strategic and proactive QA Leadership to Country and Regional GDQ Associates within a defined Cluster of countries or a Direct Country , linking global and local GxP strategy for clinical (including clinical supplies/investigational product) and pharmacovigilance quality, across Novartis divisions (Novartis Pharmaceuticals, Novartis Oncology, Sandoz Biosimilars and small molecules) covering all clinical programs (phase I to phase IV, including IITs, NIS, MAP programs) for the entire Novartis Portfolio.

Drive and implement the clinical, investigational Medicinal Product (IMP) and pharmacovigilance (PV) quality strategy throughout the countries under responsibility in close collaboration with Global Development Quality Functions and Novartis County Quality (NCQ), to ensure regional//local QA oversight and support of GCP, GMP/IMP and PV activities.

Implement the defined governance structure together to ensure appropriate quality oversight, adherence to global/local regulatory requirements and Novartis procedures, reporting and escalation within and across the countries under responsibility and up to Global Development Quality (GDQ).

Develop strategies across the Country Organizations under responsibility by implementing the shared Global vision for proactive, preventive QA where trends and prior issue resolution are translated to best practices that can be applied earlier in the product life cycle.

Foster and champion a quality culture and a quality mindset where a Quality Management System is jointly maintained with all business process owners within the Countries.

Working together with the Global Head, Clinical/PV Country Quality, GDQ implement and advance well-defined processes with impact to achieve the highest data quality standards and protection of human subject rights- and well-being through an end-to-end risk-based quality management process fully embedded to support all aspects of clinical trials, including surveillance of vendor-managed activities and business setups.

Your responsibilities include, but are not limited to:
• Ensure global and local objectives, priorities and deliverables are translated into one end-to-end quality oversight program for GCP, PV and IMP activities within the Countries under responsibility (covering all clinical programs).
• Build, lead and retain a team of high-performing quality professionals within the countries under responsibility, evaluate, mentor and coach individuals on the team to develop and retain quality leaders as well as build a culture of high performance and impact
• Oversee objective setting and performance management process among GDQ Associates within the assigned Countries.
• Member of CQA Country Quality Leadership team, representing the assigned Cluster/Country framework for GCP, PV and IMP.
• Ensure the development and deployment of quality reviews with the assigned countries; Chair QRBs for Development activities and ensure close partnership with GDD in assigned countries. Represent quality at the respective Country/Region divisional leadership team meetings/Quality Committees/Quality Review Boards together with NCQ Leaders and wherever necessary provide strategic quality and business input impacting quality and compliance activities
• Support and drive the implementation and execution of the quality strategy from GDQ and key stakeholders in the Country Organizations. divisions/BU (as set forth in the annual Quality Plans).
• Ensure up-to-date status reporting on progress of quality plans deliverables,, Key Quality Indicators and key initiatives to the relevant Country Organization key stakeholders and Global functions within GDQ
• Ensure applicable clinical development and PV processes and quality standards are implemented within and across countries, in line with worldwide HA requirements. Work with CMO & Patient Safety QA to help build PV expertise in GDQ in the countries
• Drive strategic deployment of cross-divisional lessons learned throughout the assigned Country Organizations in clinical development, based on trends from audits, inspections, and deviations/incidents; Ensure a robust learning management system is in place in each assigned country that supports business deliverables as well as associates’ training needs and that compliance is monitored.
• Ensure within assigned Countries, a process is in place for effectiveness checks and assessment of metrics, KQIs and regulatory surveillance for continuous improvement.
• Provide oversight of local regulatory inspections and ensure a robust system is in place to execute readiness activities at all levels throughout the assigned countries/region.
• Implement and maintain a robust CAPA management system to support continuous improvement efforts across the assigned Countries/Region. In collaboration with other QA organizations (Global GDQ, NCQ, PLS, NIBR), foster a culture of information sharing and best practices to support high quality clinical trials and data. Identify and support strategic quality and business initiatives, including appropriate remediation programs, quality/compliance activities and affected changes, continuous improvement initiatives for quality and compliance related areas.

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

What you’ll bring to the role:
• Degree in Life Sciences, Pharmacy or Medicines, or commensurate experience; advanced degree preferred
• At least 5 years of demonstrated leadership and accomplishments in a global/matrix environment in the pharmaceutical industry. At least 5 years people management experience incl. experience in a matrix environment
• Strong management, interpersonal, communication, negotiation and problem-solving skills.
• Strong project management skills Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams
• Ability to interact with Senior Business Leaders on a regular basis to align on the strategic direction. Strong Industry Network in clinical development
• Fluency in English as a business language (oral and written)

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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, follow us via Novartis Group WeChat Recruitment Account.
Global Drug Development
QA GDD
China
Shanghai
Quality
Full Time
Regular
No
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346034BR

Head, Clin&PV Country Quality GDQ

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