Instrumentation Laboratory Company

Sr. Manager, Quality Systems & Compliance

Instrumentation Laboratory Company • $100K — $130K *
Norcross, GA 30093In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Business, or related field.
  • 8+ years of experience in Quality Systems, Compliance, QA, or Regulatory Affairs (10+ years for Sr. Manager).
  • Proven leadership experience is necessary.
  • Expert knowledge of FDA QMSR, ISO 13485, IVDR, and MDSAP is required.
  • Strong skill set in leadership, coaching, communication, and project management.

Responsibilities

  • Own and maintain the site Quality Management System (QMS).
  • Lead Document Control, Internal Audit, Inspection Readiness, and Management Review programs.
  • Govern Deviations, Nonconformances, CAPA, Change Control, and Risk Management activities.
  • Conduct Supplier Quality governance and supplier audits.
  • Develop and report on quality metrics and compliance indicators.
  • Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
  • Build and nurture a high-performing Quality Systems & Compliance team.

Benefits

  • Professional development opportunities for continuous learning.
  • Engagement in cross-functional partnerships promoting unified quality integration.
  • A supportive environment for developing leadership skills.
Full Job Description
Overview

Job Summary
  • Responsible for leading and maintaining the Quality Systems & Compliance function for the Norcross Transfusion site. Provides strategic and operational leadership for the Quality Management System (QMS), ensuring sustainable compliance with applicable FDA Quality System Regulation (QMSR), ISO 13485, IVDR, MDSAP, and other global regulatory requirements.
  • Accountable for Quality Systems governance, document control, training compliance, internal audits, supplier quality oversight, CAPA governance, management review, inspection readiness, quality met-rics, and continuous improvement programs.


Responsibilities

Key Accountabilities
  • Own and maintain the site Quality Management System (QMS).
  • Lead Document Control, Internal Audit, Inspection Readiness, and Management Review programs.
  • Provide governance of Deviations, Nonconformances, CAPA, Change Control, and Risk Management.
  • Lead Supplier Quality governance and supplier audit activities.
  • Develop and report quality metrics and compliance indicators.
  • Drive continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
  • Lead and develop a high-performing Quality Systems & Compliance team by fostering engagement, accountability, collaboration, and continuous professional development to achieve quality, compli-ance, and business objectives.
  • Partner cross-functionally to ensure lifecycle quality integration.

Networking/Key relationships

The purpose of the interactions with the listed departments is to promote quality Quality System, Compliance, and Inspection Readiness. This role interacts with the following departments:
  • Manufacturing Operations
  • Manufacturing Technical Support
  • Laboratory Services
  • Design & Sustaining Quality
  • Regulatory Affairs
  • Post-Market Surveillance
  • Supply Chain
  • Engineering


Qualifications

Minimum Knowledge & Experience required for the position:
  • Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Business, or related disci-pline.
  • 8+ years (Manager) or 10+ years (Sr. Manager) in Quality Systems, Compliance, QA, or Regulatory Affairs within a regulated environment.
  • Leadership experience required

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
  • Expert knowledge of FDA QMSR, ISO 13485, IVDR, MDSAP, auditing, CAPA, and quality systems.
  • Strong leadership, coaching, communication, and project management skills.
  • Experience leading inspections and external audits.

Travel requirements:
Travel is required less than 10% of the time.

About Instrumentation Laboratory Company

Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
Learn more about Instrumentation Laboratory Company
Size
1,000 employees
Industry
Healthcare
Net Income
$50 million
5 Year Trend
+5%
Revenue
$500 million
* Ladders Estimates

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