Manager-1-clinical Quality

5 days ago

Gurugram Haryana, India Sun Pharmaceutical Industries Ltd Full time

**Job Purpose**

The Clinical Process and Quality Manager (CPQM) is primarily responsible to support all Global Development (GD) functions for ensuring audits and inspection readiness through periodic quality control activities.

**Key Roles and Responsibilities**
- Acts as Quality Partner for assigned Global Development Functions and drives Quality Initiatives.
- Leads, drives and supports periodic Quality Control (QC) and Inspection Readiness activities.
- Travels and Performs On-Site QC visits and helps Investigators / Site staff for audit & inspection readiness.
- Participates in Audits and Regulatory Inspection activities (preparation, conduct and post audit/inspection management).
- Ensures that the QC, Audit and Inspection findings are appropriately investigated, CAPAs are effectively implemented and lessons learned shared and implemented.
- Works closely with the Quality Assurance team and assigned GD functions and/or Contract Research Organizations (CROs) for managing cases of scientific misconduct, Serious GCP Non-Compliances, Quality Issues, assist in assessing root cause analysis, CAPA implementation.
- Performs trend analysis of all QC, audit, inspection observations, including identification of any process gaps and recommends appropriate actions.
- Provide periodic reports to stakeholders on quality related matters, risk assessment and specific quality improvement initiatives.
- Identifies and assesses risks and suggests risk mitigation strategies in collaboration with the assigned GD functions.
- Monitors adherence to SOPs and report on compliance issues, works with assigned GD function heads to address any deviations or areas of improvement.
- Supports in SOP development, training and overall tracking related activities for all GD functions.
- Becomes Reviewer for SOPs / Processes for the assigned GD functions.
- Acts as Coordinator for LMS & EDMS and Initiator / Evaluator for Trackwise as needed.
- Reviews global documents and assesses its implementation for various GD functions.
- Reviews, assesses impact of international/national regulations and guidelines on GD’s operations.
- Participate in Global Super User led meetings or other cross functional activities, as needed.
- Assists with continuous improvement efforts related to Global Clinical Quality Management.

**Qualification, Skill and Competencies Requirements**
- Bachelor’s Degree in Medicine/Pharmacy or any other Life Sciences. Master’s Degree Preferred.
- At least 10 years of experience in Clinical Research out of which 5 years’ experience of on-site monitoring of global multi-centric clinical trials.
- Previous experience of Quality Assurance / Compliance and have faced / handled audits &/or regulatory inspections
- Previous experience of interacting with Investigators, KOLs, CROs and managing quality issues.
- Strong operational understanding of ICH-GCP and Global Clinical Trials
- Good Knowledge of pertinent international, national regulations & guidelines.
- Good knowledge of Quality Management Systems. Experience Preferred.
- Exemplary organization, communication and stakeholder management skills.
- Strong negotiation skills and experience of managing difficult conversations / stakeholders.
- Ready to travel for 50% of time.

**Job Duration**

Full Time Part time

**Job Location**

Mumbai / Gurgaon / Princeton (USA)

**Reporting To**

Head - Global Clinical Quality Management (GCQM)

**Job Grade**

Manager-1 (G10)

  • Clinical Expert

    7 days ago

    Gurugram, Haryana, India Akhil Systems Full time

    **Designation**: Clinical Expert **Job Location**: Gurugram, Udyog Vihar Phase 4 **Job Purpose**: **Desired Skills**: - Minimum of 10+ years of clinical experience in a hospital or healthcare setting. - Experience working in healthcare IT, either directly or in collaboration with IT teams. - Knowledge of healthcare IT systems such as Hospital Information...

  • Image Quality Intern

    7 days ago

    Gurugram, Haryana, India UnivLabs Full time

    **Role Overview**: We are looking for a driven and detail-oriented **Image Quality Intern** to support our imaging R&D team. In this role, you will help evaluate and optimize the image output of our medical imaging devices, ensuring they meet clinical-grade standards. You’ll assist in image analysis, test automation, and performance benchmarking to enhance...

  • Clinical Instructor

    1 day ago

    Gurgaon Sector , Gurugram, Haryana, India Vidyanta Skills Institute Full time ₹ 3,91,823 - ₹ 4,78,668 per year

    We're Hiring: Clinical Instructor – Nursing / Nursing Intern – Join Our Team at Vidyanta Medical Simulation CenterAre you passionate about simulation-based learning and looking to shape the future of nursing education? Vidyanta Medical Simulation Center is seeking a clinical instructor to join our growing teamLocation: Gurgaon (Hybrid role with exciting...

  • Clinic Co-ordinator

    2 days ago

    Ballabgarh, Faridabad, Haryana, India Karma ayurveda Full time

    The Clinic Coordinator is responsible for managing the day-to-day operations of the clinic, ensuring smooth patient flow, coordinating staff activities, and maintaining high-quality patient care. This role requires strong organizational skills, excellent communication, and the ability to handle administrative tasks efficiently. **Key Responsibilities:1....

  • Clinical Data Programming

    3 weeks ago

    Gurugram, India SUN PHARMA Full time

    Job Purpose The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects. Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study Protocol, DMP, SOP...

  • Clinical Data Programming

    3 weeks ago

    Gurugram, India SUN PHARMA Full time

    Job Purpose The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects. Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study Protocol, DMP, SOP and...

  • Clinical Database Programmer

    2 weeks ago

    Gurugram, Gurugram, India SUN PHARMA Full time

    Job Description Qualification, Skill and Competencies Requirements - Preferably a minimum of a Bachelor's degree in a Life Science, Computer Science or related discipline. - Minimum 8-10 years of clinical data programming experience including working knowledge using clinical data programming tools and applications. - Experience of leading clinical...

  • Clinical Data Programming

    2 weeks ago

    Gurugram, India SUN PHARMA Full time

    Job Description Job Purpose - The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects. - Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study...

  • Quality Assurance

    7 days ago

    Gurugram, Haryana, India Human Capital Full time

    Position - Quality Assurance Engineer (Medical Devices) Industry Preferences - Medical Devices Location - Delhi NCR **Job Description -** Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER. - Participate in Risk Management per ISO14971 to...

  • Clinical Instructor

    2 days ago

    Gurgaon Sector 45, Gurugram, Haryana, India Vidyanta Skills Institute Full time

    We’re Hiring: Clinical Instructor - Nursing / Nursing Intern - Join Our Team at Vidyanta Medical Simulation Centre! Are you passionate about simulation-based learning and looking to shape the future of nursing education? Vidyanta Medical Simulation Centre is seeking a clinical instructor to join our growing team! Location: Gurgaon (Hybrid role with...