Senior Quality Specialist (Life Sciences)

TL;DR

Senior Quality Specialist (Life Sciences): Managing and enhancing quality systems and serving as the primary quality contact for clients within the life sciences industry with an accent on root cause analysis, CAPA activities, and audit coordination. Focus on resolving client-raised quality issues, driving compliance in GxP environments, and ensuring risk-based decision-making.

Location: Must be based in the United States

Salary: $69,525 - $96,820 yearly

Company

A global provider of next-generation commercialization services to the life sciences industry, serving biotech start-ups and established pharmaceutical companies.

What you will do

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

Requirements

• Bachelor's degree (Life Sciences discipline preferred).
• 1-3 years of experience in the 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.
• Strong technical skills in MS Office (Outlook, Word, Excel, PowerPoint).

Culture & Benefits

• Competitive salaries and benefits package.
• Inclusive culture embracing diversity, equity, and inclusion.
• Vision-driven environment focused on creating a healthier world.
• Focus on professional development and investing in the growth of talent.