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Senior Principal Quality Compliance Lead Clinical

Hyderabad
Posted on: 27 Sep 2021

Job details


  • NATURE OF JOB Hybrid — WFH / WFO / CW
  • CATEGORY Sales & Marketing
  • SALARY RANGE Best in the industry Annual
  • EXPERIENCE 1 – 3 Years
  • JOB TYPE Full Time
  • REGIONAL PREFRENCES India
  • NO. OF VACANCIES 1

Job description


Job Description Your responsibilities include, but not limited to : Plan, lead and implement DO Quality & Compliance across platforms, franchises or therapeutic areas. Accountable for all quality related aspects within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved. Leads discussions with internal stakeholders and partners across and outside GDD in support of quality deliverables. Leads DO and Q&C towards agreed deliverables, proactively addressing potential issues before they become problematic Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Actively participate in Q&C Team and partners with organization to progress DO towards industry best practices, simplification, agility and deliverable effectiveness. Manages and measures quality within platform, franchise or therapeutic area. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Qualitly functions. Lead independently or participate in improvement initiatives and/or non-clinical projects Coordinates exception requests, deviations and corrective/preventative action plans for corresponding processes, systems and deliverables. Lead/participate and keep current in Industry regulations and requirements. Ensure Novartis participation in industry regulation initiatives (i.e. ICH, GCP, etc.) Ensure relevant SOPs/Working practices/trainings are in place with timely training and adherence cross functionally. Proactively reviews existing processes and identify opportunities for improvement Represent Quality and Compliance regarding requirements and evaluation of systems that directly relate to DO or quality activities. Ensures DO at Novartis is considered as industry leading internally and externally; lead, influence, collaborate and proactively shape the external environment including regulatory guidelines, industry practices and professional organizations. Serves as a mentor within the DO Quality and Compliance organization, within Data Operations and cross functionally. Minimum Requirements Bachelor’s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent with atleast At least 9 years of experience in global drug development, within the pharmaceutical or device industry Significant relevant experience and knowledge in the Pharmaceutical or Device Industry. Expert in regards to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH). A demonstrated expert in Data, Programming and Process Quality, providing guidance, mentoring and support to DO Organization. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships. Outstanding verbal and written skills. Proven ability to proactively identify issues, recommend and implement solutions Division Global Drug Development Business Unit GDO GDD Country India Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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