DGM - R&D Quality. GCP QA

• Implement GCP requirements as per National & International regulatory guidelines / regulations for conducting BA/BE and Phase-I studies at Pharmacokinetic Department (PKD) through implementation of robust Quality Assurance (QA) program.

• Supervise, monitor and execute R&D GCP QA program at Vadodara to ensure compliance as per GxP and regulatory requirements for in-house and outsourced BA/BE (conducted in patients and/or in healthy volunteers) studies.

• Plan, supervise, monitor and perform audits like in-process audits, retrospective audits system/facility/process-based audits etc. of in-house and outsourced bio-equivalence studies in order to identify gaps and areas of improvement for compliance to regulatory requirements. Supervise creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards.

• Plan and conduct/ supervise qualification/ requalification audits of Contract Research Organizations (CROs), Contract Service Providers (CSPs)/ Material Suppliers.
• Verify adequacy of created & executed Corrective Action and Prevention Action (CAPA) plans.
• Support and coordinate regulatory inspections, review of regulatory response and reply to regulatory inspection queries/observations in a time bound manner. Support implementation of appropriate CAPA for the identified gaps.

• Monitor, supervise and review SOPs, ATPs, study protocols, instrument qualification, incidents, investigations and change control documents.

• Evaluate current systems and processes and create/revise and implement new/revised Standard Operating Procedures (SOPs) and global documents, as required, in collaboration with relevant stakeholders at R&D. Harmonize systems and processes with other GCP sites, as applicable.
• Ensure departmental Management Review Meetings (MRMs) are arranged and conducted on time to evaluate quality and compliance status and action items agreed are reviewed periodically.
• Issue Quality Assurance Audit Statement/ Certificate as per applicable requirements.

• Monitor overall Quality Management System of GxP functions at site.

• Create Training Plan for site R&D Quality-GCP QA team. Ensure necessary training is imparted to new joinees and existing staff and assessment of training is conducted in a timely manner. Impart or assist in imparting training and monitor training program for R&D Quality - GCP staff for applicable guidelines, regulations, best practices etc.
• 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. Ensure that performance issues are managed in a consistent and timely manner.
• 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. Ensure that performance issues are managed in a consistent and timely manner.
• Develop team expenses, capital budget and head projections. Track and manage expenditure and headcount to budget over the fiscal year.

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 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.