Principal Quality Assurance Systems Analyst

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Lead and mentor the validation team, ensuring best practices in system compliance.
• Drive validation strategies and documentation for GxP and non-regulated systems.
• Represent IT in client and sponsor audits, providing expertise on system validation lifecycle.
• Collaborate with cross-functional teams to ensure regulatory compliance and quality standards.
• Oversee software implementation, validation deliverables, and risk assessments across projects.
• Support vendor audits and corporate initiatives, including SOP development and process improvements.

What We Are Searching For:

• Bachelor’s degree with 12+ years in system quality, compliance, and validation within clinical or pharmaceutical environments.
• Proven leadership experience mentoring validation analysts and managing complex projects.
• Advanced knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and industry standards (e.g., GAMP 5, ISO 9000).
• Expertise in system testing, requirements documentation, and risk management methodologies.
• Strong vendor management experience with SaaS, IaaS, and cloud-based systems.
• Proficiency in Microsoft tools; experience with Abacus, Smartsheet, Helix ALM, and OneTrust is a plus.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $125,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

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Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status