Top 75 Quality assurance manager Jobs in Morrisville Nc

Digital QA Manager
Guerbet —Raleigh, NC
- Full-time
- 8 years
- Mentoring
- Manufacturing
14d
QA/PI Manager
State of North Carolina - Health & Human Services —Wake County, NC
- $63,927 - $111,871 a year
- Full-time
- Remote
- Experience working with individuals with developmental disabilities
- Office
- 3 years
- Paid parental leave
- Health insurance
QA Manager, GCP
Sobi —Raleigh, NC
- $112,000 - $153,000 a year
- Full-time
- Remote
- 5 years
- Senior level
- Health insurance
Quick Apply
Senior Quality Manager
Zimmer Biomet —Durham, NC
- $130,000 - $160,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Mentoring
- Wellness program
3d
External Quality Operation Manager (GMP)
Sobi —Raleigh, NC
- $120,000 - $140,000 a year
- Full-time
- Hybrid work
- 5 years
- English
- Senior level
- Health insurance
Quick Apply
Quality Assurance Contracts Manager
State of North Carolina - Health & Human Services —Wake County, NC
- $65,000 - $71,443 a year
- Full-time
- Hybrid work
- Addiction Medicine
- Office
- Bachelor's degree
- Paid parental leave
- Health insurance
Quality Control Manager (RTP)
EMCOR Government Services, Inc. —Research Triangle Park, NC
- $100,000 - $115,000 a year
- Full-time
- 5 years
- Project management
- Senior level
12d
GxP Supplier Quality Manager
Genentech —Holly Springs, NC
- $94,000 - $174,600 a year
- Online Application
- 5 years
- English
- Bachelor's degree
Quality Manager
PeopleShare —Durham, NC
- Call employer
- Spanish
- 3 years
- Master's degree
Quick Apply
Hub NAM Quality & Continuous Improvement Manager
Hitachi —Raleigh, NC
- Full-time
- Bachelor's degree
- Conflict management
- In-person
Quality Assurance Supervisor
Cencora —Cary, NC
- Full-time
- Microsoft Word
- Bachelor of Science
- Mid-level
- Paid parental leave
- Health insurance
Mgr., Product Complaints (Hybrid)
Eisai —Raleigh, NC
- $104,900 - $137,700 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Neurology
Validation Lead
Novartis —Durham, NC
- $126,000 - $234,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- 401(k) matching
3d
Sr. Manager, Product Quality Assurance
Teleflex —Morrisville, NC
- 5 years
- Writing skills
- Engineering
Quality Manager, Aerospace Composites
Anduril Industries —Morrisville, NC
- $113,000 - $171,000 a year
- Email
- Engineering
- Analysis skills
- Supervising experience
Quick Apply
QC Manager, Lab Support
Biogen —Research Triangle Park, NC
- $111,000 - $149,000 a year
- Weekends as needed
- Supervising experience
- Bachelor's degree
- Recruiting
- Paid parental leave
- Employee stock purchase plan
Traveling Quality Assurance - Quality Control Manager - MSG - Pharmaceutical
Turner Construction Company —Raleigh, NC
- $120,000 - $217,000 a year
- Full-time
- Construction site
- 5 years
- Research
- Health savings account
- Disability insurance
Senior Manager, Quality Operations
Alcami Corporation —Morrisville, NC
- Full-time
- 7 years
- Ability to walk for extended periods
- Ability to lift 50 pounds
Manager, All QC
FUJIFILM —Holly Springs, NC
- Call employer
- Mentoring
- Ability to sit for extended periods
- Recruiting
Manager, Quality Risk
Grifols —Durham, NC
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- Supervising experience

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quality assurance manager jobs near morrisville nc

Digital QA Manager

Guerbet -
Raleigh, NC

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Job Details

Full-time
14 days ago

Qualifications

Data integrity assurance
IT transformation
Operations transformation
Data quality management
Pharmaceutical company experience
Leading team collaboration initiatives
Laboratory information systems (LIS)
Manufacturing
Cross-functional team management
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The Digital Quality Assurance Manager will operate in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Digital Quality Assurance Manager is responsible for providing quality oversight, governance, and strategic direction for digital quality systems within a GMP-regulated manufacturing environment. This role ensures the integrity, compliance, and lifecycle management of computerized systems supporting manufacturing, laboratory, and quality operations, while actively driving digital transformation and continuous improvement initiatives. The position serves as a key interface between Quality, IT, Manufacturing, and Laboratory functions, ensuring that digital solutions meet regulatory expectations for data integrity, validation, security, and system performance. The Digital QA Manager also leads the development and execution of the site’s digital quality roadmap to improve compliance, efficiency, and inspection readiness.

YOUR ROLE

Provide Quality oversight for computerized systems used in GMP manufacturing and laboratory operations, ensuring compliance with 21 CFR Parts 11, 210, 211, Annex 11, and applicable global regulations.
Establish and maintain Data Integrity governance, ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Lead investigations and risk assessments related to data integrity issues, audit findings, and regulatory observations involving digital systems.
Define and approve controls for user access, audit trails, electronic records, and electronic signatures.
Provide strategic and operational oversight of electronic QMS platforms (eQMS), including exceptions, CAPA, Change Management, Complaints, Training and Document Management
Ensure configuration, workflows, and system changes are appropriately risk-assessed, validated, documented, and approved.
Act as system owner or quality system sponsor for digital QMS applications, including lifecycle management and vendor oversight at site level.
Provide QA oversight for LIMS and other computerized laboratory systems (e.g. Empower).
Ensure laboratory data integrity, sample traceability, result accuracy, and audit trail review processes are established and maintained
Participate in system validation, enhancements, periodic reviews, and system decommissioning activities.
Support laboratory inspections and audits related to computerized systems and electronic data.
Ensure systems follow a compliant CSV / CSA (Computer Software Assurance) approach based on system risk and intended use.
Review and approve validation deliverables, including URS, risk assessments, test strategies, and validation summary reports.
Oversee periodic reviews to confirm systems remain in a validated state.
Lead the development and execution of the site digital quality roadmap, aligned with business strategy, regulatory expectations, and corporate standards.
Identify and prioritize opportunities for digitalization, automation, and system integration to improve quality processes and data visibility.
Apply risk-based and Lean principles to simplify workflows, reduce cycle times, and improve compliance efficiency.
Performs other duties as assigned by management

Additional Manufacturing Quality Assurance Shift Lead Responsibilities

Serve as a trusted Quality partner to IT, Manufacturing, MSAT, and Laboratory groups on digital initiatives.
Lead and mentor QA staff supporting digital and computerized systems.
Represent Quality during internal audits, regulatory inspections, and vendor audits related to computerized systems.
Collaborate with global and corporate Quality organizations to align standards and best practices.
Ensures timely issue escalation to Quality management and Operations leadership when quality standards, process controls, or aseptic practices are at risk.
Supports reinforcement of quality culture by ensuring consistent application of GMPs, compliance for computerized systems, and procedural adherence.

YOUR BACKGROUND

Required Qualifications

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline
8+ years of experience in pharmaceutical manufacturing or quality assurance, with significant focus on computerized systems and digital quality
Strong working knowledge of CSV/CSA, Data Integrity, eQMS, and LIMS in regulated environments
Demonstrated experience leading digital transformation or process improvement initiatives
Strong understanding of global regulatory requirements and inspection expectations
Proven ability to lead cross-functional teams and manage complex projects

Preferred Qualifications

Advanced degree in Life Sciences, Engineering, or a related technical discipline
Certification in CSV, CSA, or Quality Systems (e.g., ASQ, Six Sigma)
Experience implementing or optimizing digital quality systems such as eQMS or LIMS
Experience supporting regulatory inspections related to computerized systems and data integrity
Familiarity with risk-based validation approaches and lifecycle management of computerized systems

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Refine Your Search

quality assurance manager jobs in morrisville nc

Digital QA Manager

QA/PI Manager

QA Manager, GCP

Senior Quality Manager

External Quality Operation Manager (GMP)

Quality Assurance Contracts Manager

Quality Control Manager (RTP)

GxP Supplier Quality Manager

Quality Manager

Hub NAM Quality & Continuous Improvement Manager

Quality Assurance Supervisor

Mgr., Product Complaints (Hybrid)

Validation Lead

Sr. Manager, Product Quality Assurance

Quality Manager, Aerospace Composites

QC Manager, Lab Support

Traveling Quality Assurance - Quality Control Manager - MSG - Pharmaceutical

Senior Manager, Quality Operations

Manager, All QC

Manager, Quality Risk

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