The Role
The Senior Associate in Quality Assurance is responsible for maintaining compliance with quality standards, supporting audits, analyzing risks, and overseeing quality management systems. They also provide training on data security measures and address corrective actions.
Summary Generated by Built In
Primary Responsibilities:
- To prepare, review and maintain Standard Operating Procedure, Work Instructions and policies in line with the requirements defined as per standards, guidelines, industry trends and internal policies.
- To provide support for audits (regulatory, certification, client and vendor audits).
- Review of ClinChoice Global documents such as risk tracker, non-conformity forms etc.
- To analyze root causes and review/propose CAPAs/corrections.
- Identify areas of risk in liaison with operations team and develop risk mitigation program.
- Coordinate for system implementation/improvement of QMS related activities for all support functions.
- Ensure data security/privacy measures are implemented/ managed in the relevant delivery teams by providing trainings to the delivery leads and the team members.
- Participate in Management Review Meetings and follow up for the compliance of decisions made.
- Participate and implement system upgrades as per management requirement.
- To take up further responsibilities as assigned by reporting manager or management.
Secondary Responsibilities:
- To serve as back up for all quality related functions or take up secondary responsibility as per requirement and training provided.
- Support in quality metrics management for projects.
- Review and analyze organizational level metrics as well as project engagement level metrics where applicable.
QMS/ ISMS/ PIMS Responsibilities:
- Be aware of and comply with the QMS/ ISMS & PIMS Policy.
- Participate and contribute to data protection impact assessments, risk assessments as applicable.
- Report any potential or actual security breaches to the regional and/or global DPO & security incidents to CISO/ applicable distribution list.
- Contribute towards achievement of Quality Objectives including QMS, ISMS and PIMS.
- To take up any further responsibilities as assigned by reporting manager or Management as per training provided.
Skills and Qualifications:
- Bachelor's/Master's degree in Life Sciences or equivalent
- With at least 2 years relevant experience.
Skills Required
- Bachelor's/Master's degree in Life Sciences or equivalent
- At least 2 years relevant experience
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
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The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
