Jun 22, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine! The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Development Quality Assurance Manager will be responsible for assuring quality over-sight for activities undertaken in all Novartis entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high-quality research and activities within Thailand.

Your Responsibilities:
Your responsibilities will include, but are not limited to:
• Local Quality System: Lead all aspects of implementation, maintenance, and monitoring of entities local quality compliance of and written procedures to ensure GCP and Pharmacovigilance related processes and tasks are follows Novartis global requirements and applicable regulations guidelines.
• Quality Plan and Continuous Improvement: Monitor implementation of the local Quality Plan (QP) results related to GCP and PV areas, ensuring alignment with the applicable global QP chapters where ever possible. Apply lessons learned from audits, inspections, KQI reviews and day-to-day oversight of quality performance to recommend and initiate continuous improvement efforts.
• Quality Issue Management: Drive Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Take accountability for escalation of GCP/GPvP process non-compliance as needed.
• Risk Identification and Management: Monitor local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address. Ensure adequate and timely partner concern of issues to relevant functions as needed.
• Audit Management: Partner with local and global Development teams, PS, NCQ and other cross functional in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities. Collaborate with the business, and auditees as appropriate to resolve root cause for identified audit and inspection observations (any audits and inspections related to clinical/medical, PV related areas). Verify robust and continuous corrective with preventive actions are implemented.
• CAPA management: Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action. Assure local line functions take appropriate ownership of duties as required by the CAPA processes.
• ESP/Supplier Management: Performing QA activities required for the qualification/requalification of ESPs supporting activities. Ensure the ESP selection, PV / QA agreements and oversight processes are accurately followed at the CO for ESPs supporting Development activities with a clinical/medical or PV component (including POPs).
• Data integrity: Ensure that there is a process in place to maintain local quality and compliance with requirements for digital governance platforms and computerized systems with GCP and/or GPvP impact.

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:
• Bachelor’s Degree in Pharmaceutical, Sciences or related fields
• 5+ years’ experience in the pharmaceutical industry such as pharmacovigilance, quality assurance, regulatory affairs or a directly related area.
• Minimum 3 years’ experience in Clinical Development
• Required experience in either one of; Pharmacovigilance/ Patient Safety, OR Good Clinical Practice (GCP)
• Proficient in English skills both writing and speaking

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!

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
Global Drug Development
Full Time
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Development Quality Assurance Manager

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