Senior Associate, Quality Assurance (Life Sciences)

TL;DR

Senior Associate, Quality Assurance (Life Sciences): Managing and maintaining QMS, SOPs, and policies to ensure compliance with industry standards and guidelines with an accent on audit support and root cause analysis. Focus on identifying operational risks, implementing CAPAs, and ensuring data security and privacy across delivery teams.

Company

hirify.global is a global provider of clinical research services supporting the development of new medicines and medical devices.

What you will do

• Prepare, review, and maintain Standard Operating Procedures (SOPs), work instructions, and policies according to industry standards.
• Provide essential support for regulatory, certification, client, and vendor audits.
• Analyze root causes of non-conformities and propose effective CAPAs and corrections.
• Identify operational risks and develop comprehensive risk mitigation programs in coordination with the operations team.
• Coordinate the implementation and improvement of QMS activities across all support functions.
• Ensure the implementation of data security and privacy measures by training delivery leads and team members.

Requirements

• Bachelor's or Master's degree in Life Sciences or an equivalent field.
• Minimum of 2 years of relevant experience in quality assurance.
• Knowledge of and compliance with QMS, ISMS, and PIMS policies.
• Experience participating in data protection impact assessments and risk assessments.