Quality Associate, Quality Processes

Ergomed; Maharashtra; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Ergomed in Maharashtra, India is seeking a Leadership and Compliance professional to support GxP quality, procedures, and training across global teams. You will help implement Controlled Procedures and manage access to the Group Quality Management System.

You will partner with Learning and Development, support audits and inspections, and drive metrics reporting, CAPA processes, and continuous improvement to uphold data integrity and patient safety across the organisation.

Qualifications

• University degree in Biomedical sciences or Health Sciences.
• Experience with GxP or QA in pharma/biotech.
• Ability to lead cross-functional teams and coordinate training.

Responsibilities

• Provide leadership and development to a global QA team.
• Support GxP training activities and ensure compliance with ICH/ISO guidelines.
• Assist in triage and management of Access to the QMS and related systems.
• Support audits and inspections by supplying reports from the QMS.

Skills

Leadership

Training coordination

Quality awareness

Communication

Education

Bachelor's in Biomedical sciences

Master's in Health Sciences

Tools

Quality Management System

CAPA tracking

Audit support tools

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