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Director Quality Risk Management Jobs in Raleigh, NC

Revlon Corporate

Director, Quality Control

Oxford, NC · On-site

The Director will provide hands-on technical and people leadership for QC laboratory operations ... Manage the budget and capex for QC department. Analytical Methods, Validation, and Technical ...

NCSU

Insurance and Risk Management Manager

Raleigh, NC · On-site

Direct impact on university operations, safety, and resilience * Collaborative partnerships with ... Ability to identify and address quality monitoring and performance improvement issues, as well as ...

Kelly Services

Sr QA Operations Manager

Raleigh, NC

$175K/yr

Apply quality risk management principles (ICH Q9) in all operational decision-making. Quality ... Requests for accommodation related to our application process can be directed to the Kelly Human ...

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Showing results 21-40

All JobsQuality Risk Management JobsDirector Quality Risk Management JobsDirector Quality Risk Management Jobs in Raleigh, NC

Director Quality Risk Management information

See Raleigh, NC salary details

$30.1K

$122.1K

$207.5K

How much do director quality risk management jobs pay per year?

As of Sep 10, 2026, the average yearly pay for director quality risk management in Raleigh, NC is $122,094.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,500.00 and $146,800.00 per year, depending on experience, location, and employer.

What is the difference between Director Quality Risk Management vs Quality Assurance Manager?

AspectDirector Quality Risk ManagementQuality Assurance Manager
CertificationsISO 9001 Lead Auditor, CQRMISO 9001 Lead Auditor, CQRM
Work EnvironmentStrategic, cross-departmental, compliance-focusedOperational, process-focused, team management
Industry UsageRegulated industries like pharma, healthcare, manufacturingManufacturing, software, healthcare
Search/Comparison IntentUnderstanding senior risk management rolesQuality process oversight and assurance

The main difference is that the Director of Quality Risk Management focuses on strategic risk assessment and mitigation across the organization, often working with senior leadership. In contrast, the Quality Assurance Manager concentrates on operational quality processes, ensuring products and services meet standards. Both roles require similar certifications but differ in scope and focus within the quality management hierarchy.

What does a director of quality risk management do?

A director of quality risk management oversees the identification, assessment, and mitigation of risks related to product quality and compliance within an organization. They develop strategies, implement policies, and ensure adherence to industry standards and regulations, often utilizing quality management systems and risk assessment tools. This role typically requires strong leadership, regulatory knowledge, and experience in quality assurance processes.
Infographic showing various Director Quality Risk Management job openings in Raleigh, NC as of September 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, and 2% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $122,094 per year, or $58.7 per hour.

Director, Quality Assurance (Site Quality Head)

Morrisville, NC • On-site

Encoded Therapeutics
Biotechnology Research and Development • 51 - 200 employees
Learn more about Encoded Therapeuticsexternal

Full-time

Medical, Life, PTO

Posted 20 days ago

Job description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.
Encoded Therapeutics is seeking an experienced and vision-driven Director, Quality Assurance to serve as the Site Quality Head for our Research Triangle Park (RTP) clinical manufacturing facility. In this critical leadership position, you will establish, maintain, and oversee all Site Quality Operations, ensuring phase appropriate Quality oversight and compliance with CGMP regulations, internal standards, and global regulatory expectations.
Responsibilities
Site Quality Leadership & Strategy
  • Represent QA in cross-functional team meetings and interacts with Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, Regulatory, etc. applying strong communication and collaboration skills.
  • Maintain updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
  • Drive risk-based quality decision-making, and lead escalation and resolution of critical quality events that may impact product supply, data integrity, or patient safety.
  • Author, review, and provide technical QA support for site-related sections of regulatory filings and agency interactions.
  • Support any site or regulatory body inspections.
  • Manage QA team activities to support internal operations, supply chain, quality control, and facilities.
  • Lead, mentor, and build a high-performing local Quality Assurance team.
  • Trends and reports key quality metrics to the leadership team.
Quality Operations and Product Disposition
  • Provide quality leadership and operational oversight for environmental monitoring, clinical manufacturing (AAV/Gene Therapy), analytical testing, stability, batch record review, and disposition.
  • Provide guidance and recommendations to ensure material is manufactured in accordance with established procedures, CGMPs, and appropriate regulations.
  • Lead QA oversight for analytical method data review, method validation QA approvals, tech transfer protocol/report reviews, and product specifications.
  • Author and revise QA related standard operating procedures and provides guidance for generation, review, and approval of process, equipment, test method, and other SOPs.
  • Reviews and approves all GMP related documentation including internal protocols, reports, test records, batch records, labels, specifications and other documents for drug substance.
  • Provide oversight and support staff to ensure executed batch records and associated documents to are in compliance with approved procedures and CGMP expectations to determine acceptability of product disposition.
  • Review and approve change controls related to the implementation or revision of process, method, and/or equipment changes.
  • Provide quality oversight of root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
  • Support and lead risk assessments to proactively identify, assess, and mitigate site risks.
  • Support and maintain the site Contamination Control Strategy (CCS) to mitigate cross-contamination and environmental risks.
Material and Supply Chain Quality
  • Provide quality leadership and operational oversight for raw materials and reagent release, specifications, incoming controls, and storage.
  • Lead teams to resolve any non-conforming materials and site supply chain risks.
Facility and Validation Oversight
  • Direct Quality oversight for commissioning, qualification, and validation (CQV) of site facilities, process equipment, automated systems, and analytical instrumentation.
  • Oversee site computer system validation (CSV) and data integrity initiatives to comply with 21 CFR Part 11 and global guidelines.
  • Provide Quality oversight for facilities, utilities, equipment, and instrument maintenance and management.
  • Prioritize projects appropriately and with flexibility to accommodate changing program objectives.
  • Identifies opportunities for improvement and drives continuous improvement initiatives.
  • Perform other duties and projects as assigned by management.

Requirements
  • Education: Bachelor's degree in Life Sciences or a related discipline, or Master's degree in Life Sciences or a related discipline.
  • Experience: Minimum of 12+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or biologics industry, with at least 5+ years in a senior Quality management leadership role.
  • Direct experience in Gene Therapy, Cell Therapy, Viral Vector (AAV), or Advanced Therapy Medicinal Products (ATMPs) is strongly preferred.
  • Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
  • Demonstrated track record of leading successfully through regulatory inspections (FDA, EMA, etc.).
  • Demonstrated knowledge of batch disposition, deviation/CAPA management, change control, validation, raw material quality oversight, and environmental monitoring.
  • Knowledge of Six Sigma and LEAN, and experience using root cause analysis tools to identify and correct deviations, are a plus.
  • Eligible to work in the United States.
  • Able to work on-site.

Benefits
  • Comprehensive benefits package, including competitive employer premium contributions
  • Meaningful stock option grants
  • PTO, sick time, and holiday pay
  • Generous Parental Leave program
  • Pre-tax medical and dependent care programs
  • STD, LTD, Life and AD&D
  • Professional development opportunities
  • Team-building events
  • Stocked micro-kitchen with drinks and snacks
  • Wellness Resources

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

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