Quality Associate, Quality Processes (GCP training coordinator)

Ergomed; Maharashtra; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Ergomed in India partners with global teams to strengthen quality operations across GxP. The role focuses on leadership, training, and oversight of the Quality Management System, ensuring regulatory compliance and efficient processes.

You will collaborate with cross-functional groups to support audits, CAPA, and continuous improvement in a fast-paced CRO environment. Applicants should have a university degree in biomedical or health sciences and experience in quality systems, documentation, and

Qualifications

• University degree in Biomedical sciences, Natural sciences or Health Sciences is required.
• Experience with GxP, QA documentation, and training within life sciences is preferred.
• Ability to lead cross-functional teams and drive compliance improvements.

Responsibilities

• Provide leadership for quality operations and GxP oversight.
• Support audits, CAPA, and regulatory inspections.
• Coordinate GxP training programs across the organization.

Skills

GxP Knowledge

Quality Operations

Training Coordination

Leadership

Education

Biomedical/Natural Sciences degree

Nursing/Pharmacy/BS/MS in science

Job description

Medicine moves forward here. So willyou.

Ergomed is a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, dataqualityand the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

If you wantworkwith purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

Leadership and Compliance:

• Provide support to Ergomed colleagues and functional teams in developing, managing, and implementing Controlled Procedures.
• Support GxP activities to ensure they are conducted in compliance with applicable legislation,guidelines, and standards, including ICH, CIOMS, and ISO.
• May provide guidance to Ergomend group staff over procedures and requirements related toGxP Quality Operations and Training as required.

Training and Development:

• Support GxP training activities across the Ergomed group, helping to ensure employees areadequately trained to meet global GxP requirements and client expectations, with supportfrom the Learning and Development team.
• Support GxP training to ensure it is efficient and effective and that training activities aretracked to completion
• Partner with Learning and Development to assist in the development of effective training

Quality Management System Oversight:

• May assist in the triage and management of processes controlling access to Ergomed GroupQuality Management System.
• Participate in efficiency projects to enhance the use and management of the Ergomed GroupQuality Management System.
• Ensure access requests to Controlled Systems for employees and clients are correctlymanaged.

Business Continuity and Audit Support:

• Assist in Business Continuity activities across the Ergomed Group.
• Provide support to functional and Quality teams for audits and inspections by supplyingreports or procedures from the Ergomed Group Quality Management System.

Metrics and Reporting:

• Aid the preparation and analysis of Quality Operations and Training related metrics, providingdata and periodic reports to management as required.
• Assist in preparing any required CAPA or Deviation records resulting from issues in theControlled Document, GxP Training or BCP process.

Team Leadership and Development

• Aid in fostering a collaborative, high-performing quality culture across global teams andregions.
• Provide coaching and professional development opportunities to enhance team capabilityand succession planning.

University degree in Biomedical sciences, Natural sciences or Health
Sciences is required: Nursing, Pharmacy or BS/Master's degree in a
scientific discipline, or suitable experience