Sr.Manager - R&D Quality GCP QA

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is looking for a Sr Manager – R&D Quality GCP QA based in Vadodara, India. This role requires 14 years of experience in a GCP environment with a strong background in Quality Assurance. The successful candidate will oversee QA processes, conduct audits, and support regulatory inspections while ensuring compliance with applicable guidelines.

Key responsibilities include implementing Quality Assurance Standard Operating Procedures and mentoring team members. A profound understanding of local and international GCP regulations is crucial for this position.

Qualifications

• 14+ years of experience in a GCP environment with 6 years in QA.
• Experience qualifying CROs/CSPs/Material suppliers.
• Experience handling regulatory agency inspections at sites.

Responsibilities

• Evaluate and implement QA SOPs and Global Quality Systems.
• Conduct audits for compliance with regulations and guidelines.
• Provide oversight of study documents for compliance.

Skills

Understanding of local and international GCP regulations

Experience in Quality Assurance

Customer centricity and problem-solving skills

Good communication skills

Ability to work independently

Knowledge of IT/computer systems

Job description

Sr Manager – R&D Quality GCP QA

Business Unit: Global Quality & Compliance

Job Grade: Senior Manager

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) including investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), in-process audits, etc. to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines.
• 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 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.
• Stay aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and other related regulations/guidelines and advise on their use and compliance.
• Support regulatory query response and its review. Mentor and coach direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and provision of training and development opportunities.

Qualifications

• At least 14 years of experience in a GCP environment, with at least 6 years in Quality Assurance (QA).
• High level of understanding of local and international GCP regulations and clinical research processes including outsourced studies.
• Experience implementing GCP Quality programs and conducting GCP audits.
• Experience qualifying CROs/CSPs/Material suppliers.
• Experience conducting internal and external audits.
• Experience handling regulatory agency inspections at sites.
• Ability to lead, manage and motivate people with a variety of skill sets.
• Good knowledge of IT/computer systems.
• Drive for results and excellence.
• Excellent customer centricity and problem-solving skills.
• Good communication skills with the ability to communicate effectively with all levels within the organization.
• Ability to work independently.

The preceding job description has been designed to indicate the general nature and level of work performed by an employee within this classification. It is not designed to be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.