Top 39 Assurance manager Jobs in Morrisville Nc

Digital QA Manager
Guerbet —Raleigh, NC
- Full-time
- 8 years
- Mentoring
- Manufacturing
14d
Quality Manager
PeopleShare —Durham, NC
- Call employer
- Spanish
- 3 years
- Master's degree
Quick Apply
QA Manager, GCP
Sobi —Raleigh, NC
- $112,000 - $153,000 a year
- Full-time
- Remote
- 5 years
- Senior level
- Health insurance
Quick Apply
Quality Assurance Supervisor
Cencora —Cary, NC
- Full-time
- Microsoft Word
- Bachelor of Science
- Mid-level
- Paid parental leave
- Health insurance
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
GMDP Quality Assurance Manager
WEP Clinical —Morrisville, NC
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Paid parental leave
- Health savings account
Customer Assurance Program Manager (RapidScale)
Cox Communications —Raleigh, NC
- $101,500 - $169,100 a year
- Full-time
- Azure
- Master's degree
- AWS
- Paid jury duty
- Paid holidays
13d
Sr. Manager, Product Quality Assurance
Teleflex —Morrisville, NC
- 5 years
- Writing skills
- Engineering
Assurance Manager
Sorren —Raleigh, NC
- Full-time
- CPA
- 5 years
- Office
- Paid parental leave
- Paid holidays
Quick Apply
8d
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
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
Senior Quality Manager
Zimmer Biomet —Durham, NC
- $130,000 - $160,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Mentoring
- Wellness program
3d
Assurance Manager - Raleigh
Smith & Howard Advisory LLC —Cary, NC
- CPA
- Mid-level
- Office
- Opportunities for advancement
Quick Apply
Quality Assurance Manager (Onsite)
Voltage LLC —Chapel Hill, NC
- Full-time
- 5 years
- Engineering
- Analysis skills
Quick Apply
Manager, Quality Risk
Grifols —Durham, NC
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- Supervising experience
Manager , Audit & Assurance Growth
Deloitte —Raleigh, NC
- $84,300 - $173,300 a year
- Full-time
- Marketing
- 5 years
- Master's degree
GxP Supplier Quality Manager
Genentech —Holly Springs, NC
- $94,000 - $174,600 a year
- Online Application
- 5 years
- English
- Bachelor's degree
Product Quality Manager
PowerSecure, Inc. —Durham, NC
- Full-time
- English
- Office
- Bachelor's degree
- Health savings account
- Paid holidays
Quick Apply
2d
Assurance Senior Manager - Commercial
EisnerAmper LLP —Raleigh, NC
- Full-time
- Hybrid work
- CPA
- Office
- 3 years
Quality Manager
Micross Advanced Interconnect Technology —Durham, NC
- Bachelor of Science
- Engineering
- ERP systems
- Health savings account
- Paid holidays
Quick Apply

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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

assurance manager jobs in morrisville nc

Digital QA Manager

Quality Manager

QA Manager, GCP

Quality Assurance Supervisor

QA/PI Manager

GMDP Quality Assurance Manager

Customer Assurance Program Manager (RapidScale)

Sr. Manager, Product Quality Assurance

Assurance Manager

Traveling Quality Assurance - Quality Control Manager - MSG - Pharmaceutical

Quality Assurance Contracts Manager

Senior Quality Manager

Assurance Manager - Raleigh

Quality Assurance Manager (Onsite)

Manager, Quality Risk

Manager , Audit & Assurance Growth

GxP Supplier Quality Manager

Product Quality Manager

Assurance Senior Manager - Commercial

Quality Manager

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