Senior Quality Associate

Experience : 4 to 6 years

Location : Remote

1. Provide Operational Quality Management System (QMS) support, ensuring implementation, maintenance, compliance and audit readiness with, but not limited to:

ICH GCP E(R3) experience

ICH Q10 experience ISO 9001:2015 (Quality Management)

ISO/IEC 27001:2022 (Information Security Management)

ISO 22301:2019 (Business Continuity Management)

GVP, is not mandatory but preferred

2. Drive ongoing quality assurance and compliance monitoring across assigned accounts, ensuring adherence to internal process and external regulatory requirements as mentioned above.

3. Support Vendor Management Program, including:

Vendor risk assessment maintenance

Audit planning, scheduling, execution support, documentation, and closure tracking

4. Monitor and ensure organizational training compliance, including tracking completion, effectiveness, and audit readiness.

5. Demonstrated ISO implementation and compliance experience, specifically in establishing and maintaining certification readiness.

6. Certification Requirement (Mandatory): Certified in at least one of the following:

ISO 9001:2015

ISO/IEC 27001:2022

ISO 22301:2019

Additional Preferred Certifications:

ICH-GCP (Good Clinical Practice)

GDPR / Data Privacy certifications

7. Strong project management skills:

Ability to plan, track, and ensure timely closure of QMS activities, audits, CAPAs, and compliance deliverables

8. Excellent stakeholder management skills:

Ability to collaborate with cross-functional teams, vendors, auditors, and leadership for compliance

Additional Must have skills :-

1. Hands-on experience with electronic Quality Management Systems (eQMS) such as:

OneQMS, TrackWise, or equivalent platforms

2. Support development, review, and updates of:

SOPs, policies, manuals, and controlled documents within eQMS

Ensure alignment with latest ICH-GCP, GVP, GDPR, and ISO standards, especially within CRO/clinical research environments

3. Practical experience in QMS processes, including:

CAPA (Corrective and Preventive Actions)

Deviations and non-conformances

Change control management

Root Cause Analysis (RCA) identification and investigation

Audit management and documentation

Incident Management