A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager Vendor QA
Job Description
QA point of contact for assigned CMO & Patient Safety global vendor, in close collaboration with the Global Head, Vendor QA and the vendor management team. Provide continuous improvement opportunities to assigned vendors, through assessments of documents, processes, pharmacovigilance systems and operations. Assist with assessments for the need and management of due diligence activities, including Quality Assessments (QAV) and related corrective and preventative actions, as appropriate. Provide quality support to the Vendor Management team to ensure PV activities/processes are transferred and sustained according to the Novartis quality standards. Provide support to global vendors in preparation for, during and following-up for Novartis audits, as assigned. Provide support to specific initiatives focused on quality, process and compliance improvement. Support CMO and Patient Safety Vendor Management team with initiatives focused on inspection readiness. Support to ensure information gained during initiatives focused on compliance and quality improvement, as well as audit and assessment results, is evaluated to identify specific regulatory, compliance and quality assurance training needs for as-signed global vendor. Lead the development, implementation and conduct of appropriate training. Contribute to the development of the PV elements of the Development Quality Plan and execute deliverables as assigned. Assist with support to Health Authority Inspections. Assist with support in the development of corrective and preventative action plans (CAPA) in collaboration with the responsible vendor and CMO and Patient Safety team. Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed and appropriately documented. Provide assistance in the remediation of PV-related internal and vendor deviations. Analyze root causes for non-compliance through process review. Ensure follow-up and monitoring of associated corrective and preventive actions.
Timely, complete and effective communication, consultation and support to vendor management/ vendors, in CMO and Patient Safety. Timely escalation through proper channels of issues and findings that impact on Novartis’ pharmacovigilance and risk benefit evaluation capabilities. Effective collaboration on quality/compliance remediation and improvement initiatives for assigned vendors. Timely review and feedback on policies, guidelines and procedures
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Candidate Profile
Degree in Life Sciences or related scientific discipline. Higher degree desirable. Good written and verbal English communication skills; fluency in a second language a plus Three plus years quality/ PV/ clinical/ regulatory affairs/ pharmaceutical industry/ Health Authority experience; GCP/PV auditing or inspection and Health Authority interactions experience a plus; Ability to travel up to 20%; Ability to manage and objectively evaluate complex compliance issues; Excellent problem solving, decision making and prioritization skills; Quality mindset and good compliance facilitation skills; Knowledge of PV regulations, guidelines and policies; Awareness of GCP and Part 11 requirements; Ability to operate successfully in various team capacities and diverse cultural environments; Excellent computer skills, including Excel and Word.
Additional Information:
Job ID: 213048BR
Location: Hyderabad
Division: Global Drug Development
Business Unit: QA GDD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Quality
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