Position Details
About this role
This role leads the integration of software quality assurance, compliance, and automation teams within a pharmaceutical environment, ensuring regulatory standards are embedded into technology solutions and processes.
Key Responsibilities
- Lead liaison between SQA and compliance; Interpret and translate compliance requirements; Develop and validate traceability matrices; Embed quality controls into TSL tools; Lead process improvement programs
Technical Overview
Focuses on quality assurance, validation, regulatory compliance, automation, and digital quality systems within regulated pharma environments, utilizing tools like Azure, GitHub, and AWS.
Ideal Candidate
The ideal candidate is a senior quality assurance professional with extensive experience in pharmaceutical regulatory requirements such as GxP, CSV, and Part 11. They possess strong expertise in automation, validation, and compliance processes, with a background in integrating digital quality systems within regulated environments.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with GxP, CSV, Part 11, or Annex 11, No experience with Azure, GitHub, or AWS, No regulatory compliance background, Less than 8 years of relevant experience, Unwillingness to work in North Chicago, IL
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