Director, Quality Assurance (Bioservices)

TL;DR

Director, Quality Assurance (Bioservices): Leading global quality and compliance strategies for regulated diagnostic and companion diagnostic product portfolios with an accent on FDA QSR, ISO 13485, and ISO 15189 standards. Focus on directing cross-functional quality operations, managing global QMS, and ensuring regulatory readiness for clinical trials and commercial products.

Location: Must be based in Frederick, MD, USA

Salary: $162,000 - $243,000 USD

Company

hirify.global is a specialized services company supporting the development and commercialization of life-changing therapies and diagnostics.

What you will do

• Plan and direct quality and compliance resources across all global facilities.
• Provide oversight of global Quality Management Systems for laboratories, clinical trials, and commercial products.
• Lead quality responses for regulatory inspections, client assessments, and business development proposals.
• Ensure compliance with FDA QSR, IVDD/IVDR, ISO 13485, and ISO 15189 standards.
• Collaborate with cross-functional teams to support design control and risk management for medical devices.
• Serve as the Management Representative designee for periodic quality system reviews.

Requirements

• Bachelor’s degree in physical, Biological Sciences, or technical/scientific field.
• 10-12 years of experience in a quality-driven, regulated life science environment.
• 5 years of supervisory experience.
• Hands-on experience with medical device pre- and post-market activities.
• Ability to travel up to 30% domestically and internationally.
• Fluent in English (reading, writing, speaking).

Culture & Benefits

• Comprehensive health insurance, life insurance, and disability benefits.
• Retirement savings benefits.
• Discretionary annual bonus.
• Paid time off for vacation and sick leave.
• Parental leave.