Bioanalytical Quality Assurance Unit Manager (Medtech)

Location: Onsite in Gaithersburg, MD, USA

Salary: $116,600 – $177,800

Company

hirify.global provides advanced bioanalytical tools and services for clinical and preclinical research.

What you will do

• Implement and maintain QAU laboratory policies and procedures in compliance with GLP and GCLP.
• Supervise QAU staff in technical reviews of study reports, archiving, and internal audits.
• Act as SME for customer questionnaires and audits, coordinating BAL resources and responding to findings.
• Review deviations and CAPAs, assisting with root cause investigations and customer communications.
• Oversee continuous improvement initiatives and mentor staff in GLP/GCLP principles and CAPA best practices.
• Establish and monitor staff performance goals, objectives, and priorities.

Requirements

• Bachelor’s degree in a health or science-related field.
• Minimum of 7 years of experience in a Quality role supporting GLP/GCLP bioanalysis.
• Minimum of 2 years of supervisory or management experience.
• Advanced knowledge of FDA GLP and EU M6 GCP requirements for bioanalytical labs.
• Familiarity with FDA Bioanalytical Method Validation, ICH M10, and OECD GLP guidance.
• Ability to work in a Biosafety Level 2 (BSL-2) laboratory environment.

Nice to have

• Professional Quality Certification (e.g., ASQ, ASCP).
• Experience with protein-based immunoassays and antibody-based assays.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage including prescription benefits.
• 401(k) plan with company matching.
• Paid vacation, sick leave, holidays, and parental leave.
• Company-paid short- and long-term disability and group life insurance.
• Additional perks: fitness club membership contribution, pet insurance, and identity theft protection.
• Inclusive workplace committed to equal opportunity and diversity.