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Sr. Clinical QA Manager

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Provide strategic Quality Assurance (QA) support at the Novartis Global Service Center for Post launch Scientific Services (PLSS) Clinical Team (CT), in the Scientific Services Practice within Product Lifecycle Services (PLS) and for respective medical services which fall under GxP. Closely collaborate with the PLS business partners to ensure GxP compliance and provide quality oversight for the respective service scope of the clinical trials (CT). Support the implementation of a risk based quality management process fully embedded into the clinical trial service delivery including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patients rights and well-being and in support of successful Health Authority inspections.Provide operational QA support to the PLS clinical team, including quality oversight for Health Authority commitments, critical incidents including respective escalation process and the im- plementation of corrective & preventive actions (CAPAs) for the respective business areas.Act as QA contact to the customer QA organization in line with established quality agreements. 1. Drive the implementation of the quality requirements within the PLS clinical team. Monitor & track implementation of the Quality Plan deliverables with the supported CT including the quality risk assessments & inspection readiness components for the designated CTs. 2. Provide Quality input & oversight for the execution of CTs or respective services under the responsibility of PLS. 3. Lead the quality requirement assessment for new services in collaboration with the business teams.4. Lead the clinical part of the local Quality Review Board to ensure appropriate management review of all quality & compliance related topics including the review of key quality indicators (KQI); identify appropriate continuous improvement initiatives for quality & compliance related areas.5. Support strategic CT Quality and Business initiatives, including the design & implementation of respective quality & compliance activities & affected changes, the support of remediation programs & the development/ implementation of strategic process improvement.6. Facilitate effective communications within the CT and by interacting with other QA functions & the customer QA in line with established quality agreements.7 Ensure that applicable PLS clinical processes are implemented in line with the service scope. Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.8.Monitor effectiveness of implementation of applicable clinical processes through KQIs in collaboration with business process owners to demonstrate that processes are in control & ensure required compliance levels.. Implement and lead the process to regularly review and assess KQIs at the respective CTs. Ensure that potential gaps and risks are addressed & opportunities for continuous improvement identified. 10. Ensure & provide effective Quality oversight / management for the following areasAdequate & timely escalation of incidents/issues within CTs and QA. Timely & effective initiation of investigations. Definition of adequate CAPAs are defined, their implementation & effective closure tracked. Qualification and management of vendors for outsourced activities.Provide quality oversight for Change Control Implementation of a self-assessment/self-inspection process.Implementation of adequate training within the respective CTs through respective tracking systems and effectiveness checks additional accountabilities added UNDER COMPETANCY PROFILEMinimum requirementsDegree in Life Sciences, Pharmacy or Medicines. Ad- vanced degree a plus. Fluency in English (oral and written) At least 4 - 6 years of involvement in regulated activities, clinical development and QA positions; broad under- standing of global expectations of Health Authorities in the area of Clinical Development; profound understand- ing of the science of product development. Ability to work independently and in a team environment. A minimum of 3 years experience in managing projects. Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors. Strong skills in GCP, quality and/or clinical development. Strong interpersonal, communication, negotiation, and problem solving skills.Strong project management skills desirable.Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.Knowledge and understanding of cultural differences and diversity issues.
Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 4-6


Clinical Research | Quality Assurance/ Control
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