Manager - R&D Quality GCP QA

Job Title Manager R&D Quality GCP QA Business Unit Sun R&D Quality Job Grade G11A / G10 Location Vadodara Key responsibilities Evaluate current systems and processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and Global Quality Systems/ SOPs (GQSs/ GSOPs) in collaboration with relevant stakeholders in R&D. Conduct the outsourced BA/BE study audits (both healthy volunteer and patient based) which include investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), In-process audits etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines. Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) Qualification/ Re-qualification audits. Verify adequacy of all created & executed CAPAs, including CAPA identified as a result of audit by corporate audit department, followed by adequacy and effectiveness check of implemented CAPAs. Harmonize the QA systems and processes, wherever applicable and feasible, across the organization for in-house and outsourced BA/BE Studies. Provide GCP QA oversight in creation/ review of study documents (e.g. study protocol, study plans, IB, ICFs, clinical study report etc.) for in-house and outsourced BA/BE studies in compliance with applicable guidelines, regulations and Good Documentation Practice (GDP). Support for conduct of regulatory inspection in collaboration with other R&D stakeholders involved in in-house and outsourced clinical studies. Collaborate for creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner. To be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and other regulations / guidelines related to in-house and outsourced clinical studies and advice on their use and compliance. Support to Regulatory query response and its review. Mentor and coach both the direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Travel Estimate 6 to 8 days in a month. Educational Qualification Minimum graduate / post graduate degree in basic sciences Experience Tenure: At least 10 years of experience in GCP environment of which at least 06 years experience must be in Quality Assurance (QA). Technical Competencies High level of understanding of local and international GCP regulations and clinical research processes including of outsourced studies. Experience of implementing GCP Quality programs and conducting GCP audits Experience of qualification of CROs/CSPs/ Material suppliers. Experience of conducting internal and external audits. Experience in handling regulatory agency inspections at sites Excellent auditing skills. Ability to lead, manage and motivate people with a variety of skill sets Good knowledge of IT/computer systems. Behavioral Competencies / Soft Skills Drive results and excellence. Excellent customer centricity and problem-solving skills. Good communication skills with the ability to communicate effectively with all levels within organization. Ability to work independently Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. J-18808-Ljbffr