Senior Quality Specialist (Pharmaceuticals)

TL;DR

Senior Quality Specialist (Pharmaceuticals): Supporting and enhancing quality systems and serving as the primary point of contact for client quality matters with an accent on root cause analysis and CAPA activities. Focus on leading investigations, coordinating cross-functional responses to audits, and maintaining compliance in a GxP environment.

Location: Memphis, TN, USA

Salary: $69,525 - $85,000 yearly

Company

Global provider of next-generation commercialization services to the life sciences industry, serving over 670 biotech and pharmaceutical clients.

What you will do

• Manage quality systems and serve as the primary quality point of contact for assigned clients.
• Lead the resolution of client-raised quality issues, complaints, and concerns.
• Facilitate investigations, root cause analysis, and corrective/preventive actions (CAPA) with cross-functional teams.
• Coordinate internal responses to client audits, assessments, and site visits.
• Prepare quality system documentation and data requested by clients.
• Escalate quality risks to leadership using risk-based decision-making.

Requirements

• Bachelor’s degree (discipline in life sciences preferred).
• 1-3 years of experience in pharmaceutical, biotech, or medical device industry, or quality assurance in a GxP environment.
• Strong problem-solving, risk assessment, and impact analysis abilities.
• Excellent oral and written communication skills.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Must be based in Memphis, TN, USA.

Culture & Benefits

• Certified Great Place to Work with a focus on diversity, equity, and inclusion.
• Inclusive culture rooted in patient-mindedness and client delight.
• Competitive salaries and comprehensive benefits package.
• Collaborative environment encouraging talent growth and constant innovation.