Director, Quality Operations

LabConnect

Quality operations director leading US clinical and laboratory quality compliance. Overseeing QA/QC strategy, audits, metrics, CAPA, SOPs, validation, and global team development.

Posted 8/5/2026full-timeRemote • Tennessee • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Quality Assurance and Quality Control within clinical and laboratory environments, with a strong focus on regulatory compliance and risk management. Proven leadership capabilities in supervising teams, developing quality strategies, and enhancing quality culture through effective communication and collaboration.

Highest-signal resume keywords

Quality Assurance LeadershipRegulatory Compliance ExpertiseClinical Trials ExperienceGCP/GxP KnowledgeProject Quality Control SOP Development

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality AssuranceQuality ControlRegulatory RequirementsCAPA PlanningMetrics MonitoringDesign VerificationRisk ManagementData ManagementClinical Environment ExperienceLaboratory Environment Experience

Soft Skills

Effective CommunicationProblem-SolvingAttention to DetailInterpersonal SkillsTime Management

Tools & Technologies

Microsoft WordMicrosoft ExcelDatabase Software

Certifications & Qualifications

Research Quality Association Cert-GCPResearch Quality Association Cert-GCLPEOQ Certified Quality Auditor

Industry Keywords

Quality CultureGlobal Quality ControlClient AuditsRegulatory InspectionsQuality Event Investigations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and execute the annual US Quality Plan aligned with global strategy
Provide oversight of US Quality Assurance operations and Global Quality Control
Advise US Operations and senior leadership on quality strategy, regulatory requirements, and compliance risks
Lead strategic projects that enhance quality culture and improve processes and outcomes
Oversee design verification and quality control review processes
Direct study QC support documentation reviews
Establish and monitor US QA and Global QC metrics; report outcomes and recommend improvements
Participate in quality-event investigations and CAPA planning
Author, review, and approve Project Quality Control SOPs
Coordinate and host client audits and prepare the organization for regulatory inspections
Collaborate across departments to align QC reviews with current processes and standards
Provide regulatory and compliance risk reviews of contractual negotiations
Partner with global QA and IT staff on systems validation and compliance initiatives
Supervise, coach, and develop Quality Control Specialists and other team members
Oversee training-material creation and staff readiness for evolving quality standards
Interface with laboratory, customer service, business development, project management, IT, and data management teams

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field (required)
10+ years of experience in a clinical or laboratory environment with increasing responsibility in quality assurance/control (required), or a combination of roles in Life Sciences focused on Quality and Regulatory
4+ years of leadership experience, including direct supervision of teams (required)
Experience in clinical trials and laboratory environments with focus on GCP/GxP (preferred)
Global work experience with teams and clients across cultures and time zones (preferred)
Research Quality Association Cert-GCP or Cert-GCLP, or EOQ Certified Quality Auditor (preferred)
Proven ability in quality/regulatory leadership
Strong planning, problem-solving, and risk management skills
Excellent attention to detail and ability to adapt to changing environments
Effective communication, public speaking, interpersonal, and listening skills
Demonstrated business acumen and ability to make timely, well-considered decisions
Excellent organization and time management skills
Proficiency in Microsoft Word, Excel, and database software
Fluent in English; additional language skills are a plus
Ability to perform prolonged desk, computer, headphone, phone, video, and email work
Minimal travel availability

Benefits

Comp & perks

Minimal travel requirements