Development QA Associate Manager

Development QA Associate Manager
Position Purpose

• Responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight, assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV).
• Ensure in direct collaboration and partnership with the CPO Medical Department (including GenMed, Oncology, DS&E, DRA and MA) the implementation of the Novartis Quality Manual and Quality Management System in the CPO Medical Department to achieve a high level of quality and compliance.

Key responsibilities

• Implement & maintain the local Quality System in the areas of GCP & GPvP, in accordance with Novartis Quality Management & the CPO Quality Plan, through strong collaboration with Country Quality QA.
• In cooperation with local Regulatory Affairs (RA) & Drug Safety and Epidemiology (DS&E), keep abreast of regulatory requirements, & update local management & Pharma Development MA / Country Quality on the possible ramifications of regulatory changes & impact to Clinical Development, MA & PV processes.
• Conduct proactive in-process quality & compliance review through monitoring of adequate Key Quality Indicators (KQIs) & assure that gaps are addressed appropriately in order to mitigate risk.
• Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, MA & PV activities. Ensure the ESP selection process properly followed at the CPO.
• Provide QA oversight for PSPs, MAPs & IISs.
• Partner with Global Development Quality in the preparation, execution & follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major & critical audit. Verify that appropriate corrective & preventive actions are implemented on all major & critical audit findings.
• In cooperation with the Country Quality Unit ensure analysis, assessment & resolution (including CAPAs where indicated) of issues with common interfaces.
• Participate in PH Dev QA investigation activities, as appropriate.
• Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity (e.g. local Health Authorities (HA) inspections).
• Ensure CPO readiness for all GxP regulatory inspections.
• Provide support prior to, during & after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local HAs have been submitted, commitments have been met & relevant CAPs have been completed/closed.
• Ensure conduct of adequate training at the CPO for all GCP & GPvP activities by defining, planning & supporting training activities.
• Ensure that the clinical & PV computerized systems are adequately identified during the High Level Risk Assessment for GXP relevance to enable their validation where required.
• IMP Mgmt:
o Responsible or provide support for Quality oversight of secondary packaging activities at third party regional hub.
o To manage iDS hub for region AMAC ASIA cluster & AUSTRALIA.
o Perform release of IMPs for clinical trial sites as applicable.

• Degree in Life Sciences or related fields
• Good communication and interpersonal skills.
• Minimum 4-10 years’ experience in the pharmaceutical industry in a relevant field (quality assurance, clinical research, Pharmacovigilance, GCP/ PV Auditing or directly related area).

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas.

In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world.

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Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Pharma QA
Full Time