Quality Associate, Quality Processes (GCP training coordinator)

ERGOMED; Pune District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Ergomed, a specialist clinical research organization, is seeking a Leadership and Compliance professional to support GxP quality operations across the Ergomed Group. You will help develop, manage, and implement controlled procedures to ensure regulatory alignment.

The role involves training coordination with Learning and Development, facilitating audits, and contributing to business continuity and metrics. This position offers challenging, meaningful work within a global, collaborative team.

Qualifications

• 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.

Responsibilities

• Provide support to develop, manage, and implement Controlled Procedures.
• Support GxP activities to ensure compliance with ICH, CIOMS, and ISO.
• May provide guidance to Ergomed staff over GxP Quality Operations and Training.
• Support GxP training across the Ergomed group, ensuring training meets global GxP requirements and client expectations.
• Assist in the triage and management of processes controlling access to Ergomed Group Quality Management System.
• Participate in efficiency projects to enhance QMS use and management.
• Ensure access requests to Controlled Systems are correctly managed.
• Assist in Business Continuity activities and audits/inspections by supplying reports or procedures.
• Aid in preparation and analysis of Quality Operations and Training metrics; assist in CAPA/Deviation records.
• Foster a collaborative, high-performing quality culture across global teams and provide coaching.

Education

Biomedical/Natural/Health sciences degree

Job description

Company Description

Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, 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, data quality and 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 their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. If you want work with 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.

Job Description

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 to GxP Quality Operations and Training as required.

Training And Development

• Support GxP training activities across the Ergomed group, helping to ensure employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team.
• Support GxP training to ensure it is efficient and effective and that training activities are tracked 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 Group Quality Management System.
• Participate in efficiency projects to enhance the use and management of the Ergomed Group Quality Management System.
• Ensure access requests to Controlled Systems for employees and clients are correctly managed.

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 supplying reports or procedures from the Ergomed Group Quality Management System.

Metrics And Reporting

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

Team Leadership and Development

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

Qualifications

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