Top 85 Quality manager Jobs in Huntersville, Nc

HAL Quality Manager
BioCytics Inc —Huntersville, NC
- Full-time
- Background check
- Pass drug screening
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Quality Manager
Reynolds Consumer Products —Huntersville, NC
- $98,400 - $139,000 a year
- Bachelor's degree
- Organizational skills
- Business Administration
17h
Program Manager- Duke Lake Norman Quality Assurance
Duke Health —Mooresville, NC
- Full-time
- Customer service
- Mid-level
- Analysis skills
8d
Quality Assurance Manager
Carrier —Charlotte, NC
- $143,000 - $286,000 a year
- Full-time
- Management
- 5 years
- English
- Paid training
- Wellness program
Compliance Quality Assurance Manager (US)
TD Bank —Charlotte, NC
- $86,840 - $139,360 a year
- Full-time
- 7 years
- CPA
- Writing skills
- Health insurance
- Paid time off
Quality Manager
Fibreworks Composites LLC —Mooresville, NC
- Overtime
- Management
- 5 years
- Computer literacy
- Health insurance
- Dental insurance
9d
Automation Test Lead
The Hartford —Charlotte, NC
- $127,600 - $191,400 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- 5 years
1d
Quality Manager (ISO 9001 / Metal Fabrication Manufacturing)
Everforth, Cybercoders —Denver, NC
- $90,000 - $130,000 a year
- Full-time
- Mid-level
- 3 years
- US work authorization
- Paid holidays
- Health insurance
10d
FSQA Supervisor
Bakkavor —Charlotte, NC
- Extended hours
- Spanish
- Ability to walk for extended periods
- 5 years
- Health savings account
- Health insurance
Quick Apply
Sr. Director, Quality
Xylem —Charlotte, NC
- $180,000 - $230,000 a year
- Full-time
- Engineering
- 11+ years
- Residential
- Paid parental leave
- Health insurance
Field Quality Manager - Michels Pipeline, Inc.
Michels Corporation —Charlotte, NC
- Clean driving record
- Mid-level
- 3 years
- Health savings account
- Disability insurance
Quality Supervisor
Ryder System —Concord, NC
- $70,000 - $75,000 a year
- Urgently hiring
- Mid-level
- High school diploma or GED
- Analysis skills
- Paid holidays
- Disability insurance
Project Quality Completions Manager
Zachry Group —Terrell, NC
- Full-time
- 5 years
- Bachelor's degree
- Senior level
Supervisor, Operations
Southwire Company LLC —Huntersville, NC
- Overtime
- High school diploma or GED
- Team management
- Warehouse
- Paid holidays
- Disability insurance
7d
Manager I, Quality
Novolex —Mooresville, NC
- Weekends as needed
- 5 years
- Bachelor of Science
- Math
- Health insurance
- Dental insurance
Manager, Quality Control
Aecon Group —Charlotte, NC
- Email
- 7 years
- Word processing
- Computer literacy
- Tuition reimbursement
Quality Manager
Wanzl NA —Denver, NC
- Management
- Engineering
- Travel
Quick Apply
8d
Quality Assurance Quality Control (QA/QC) Manager
Bureau Veritas Primary Integration —Charlotte, NC
- Full-time
- Management
- Construction site
- Mid-level
Quick Apply
Corporate Quality Manager - Field Services
Owens Corning —Charlotte, NC
- Residential
- 3 years
- Supervising experience
2h
Quality Assurance/Quality Control Manager
Eskola LLC —Charlotte, NC
- $140,000 - $160,000 a year
- Full-time
- Background check
- Construction site
- Travel
- Health savings account
- Disability insurance
Quick Apply
14d

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quality manager jobs near huntersville, nc

HAL Quality Manager

BioCytics Inc
Huntersville, NC

Quick Apply

Job Details

Full-time

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Team leadership
Corrective and preventive actions (CAPA)
Supervising experience
Bachelor's degree
Quality risk management
Biomedical regulatory compliance
Laboratory staff supervision
Quality audits
GMP for research safety and compliance
Managing product quality assurance teams
Supplier quality assurance (SQA)
FDA regulations
Customer complaint resolution

Full Job Description

The Human Applications Laboratory (HAL) Quality Manager is responsible for leading the development, implementation, and ongoing maturation of the Quality Management System (QMS) supporting GMP and GLP operations for cellular immunotherapy products, including immune cells, within the Human Applications Laboratory (HAL). This position will establish the quality infrastructure necessary to support compliant laboratory operations by developing quality processes, Standard Operating Procedures (SOPs), Quality Control (QC) programs, controlled documentation, training programs, and quality records in accordance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and internal quality standards.

Responsibilities:

Quality Management System (QMS)

· Lead the development, implementation, maintenance, and continuous improvement of the Human Applications Laboratory (HAL) Quality Management System (QMS) supporting GLP and GMP operations.

· Develop, implement, and monitor quality policies, procedures, forms, and work instructions to ensure compliance with applicable regulatory requirements and industry standards.

· Ensure compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), Good Documentation Practices (GDP), and other applicable regulations and accreditation standards.

· Partner with laboratory leadership to establish quality objectives, quality metrics, and continuous improvement initiatives.

Document Control and Quality Records

· Develop, review, approve, revise, and maintain SOPs, batch records, controlled forms, specifications, validation documentation, and other quality records.

· Ensure timely and accurate completion, review, and retention of GMP and GLP documentation, including laboratory records, batch records, equipment logs, training records, QC documentation, and quality reports.

· Maintain document control processes and ensure version control of all controlled documents.

Quality Assurance and Quality Control

· Support the QC Specialist in the development of and oversee the Quality Control (QC) programs for laboratory operations and cellular therapy manufacturing.

· Review and approve analytical testing, reagent verification, equipment qualification, process validation, environmental monitoring, and batch documentation.

· Review and approve material receipt, inspection, release, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and product disposition.

· Monitor quality performance through quality indicators, QC charts, monthly quality monitors, and trend analysis.

Quality Systems

· Manage deviations, nonconformances, investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), Change Control, and risk assessments.

· Perform trend analysis of quality data to identify recurring issues, systemic risks, and opportunities for process improvement.

· Prepare quality metrics, management reports, and quality summaries for leadership review.

· Maintain inspection readiness and facilitate internal, customer, vendor, and regulatory inspections.

Supplier and Regulatory Quality

· Develop and maintain supplier qualification and supplier monitoring programs.

· Investigate customer complaints and coordinate appropriate quality actions.

· Support regulatory inspections, accreditation activities, and customer audits, including responses to findings and implementation of corrective actions.

· Ensure compliance with FDA regulations, AABB Standards, FACT Standards, and other applicable regulatory requirements.

Training and Personnel Qualification

· Develop and maintain quality training, orientation, competency assessment, and personnel qualification programs.

· Ensure personnel training and competency records remain current and compliant.

· Support qualification of personnel for GMP activities, including aseptic processing, as applicable.

Laboratory Operations Support

· Collaborate with the HAL team to ensure GMP processes for the isolation, processing, expansion, characterization, and storage of immune cells are compliant.

· Support development, validation, qualification, and continuous improvement of laboratory processes, equipment, biobanking and manufacturing workflows.

· Support FDA IND-enabling activities and Phase I clinical trial manufacturing through quality oversight and documentation review.

Technical Laboratory Responsibilities

· Oversee quality review of bioanalytical testing, including flow cytometry, cell counting, microscopy, immunomagnetic cell selection, fluorescence-activated cell sorting (FACS), and related laboratory techniques, as required.

· Ensure appropriate equipment qualification, calibration, maintenance, and documentation.

Operational Support

Perform additional Quality duties and special projects as assigned.

Qualifications:

Minimum of 7 years of progressive experience in regulated quality systems.
Demonstrated experience developing and implementing GMP Quality Management Systems.
Cell therapy or biologics experience.
Startup GMP facility experience.
Experience supporting FDA inspections.
Experience with deviations, CAPA, Change Control, document control, risk management, training, supplier qualification, and internal auditing.
FACT or AABB experience preferred.
Minimum of 3 years of leadership experience supervising quality personnel. Supervisory required, management preferred

Education Requirements:

Bachelor's degree in a scientific, engineering, or related discipline required.
Preferred: ASQ certification

Work Location:

One location

Work Remotely:

Job Type: Full-time

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Application Question(s):

Are you willing to undergo a background check, in accordance with local law/regulations?
Are you willing to take a drug test, in accordance with local law/regulations?
Will you now or in the future require employer-sponsored work authorization (e.g., H-1B visa sponsorship) to work in the United States?

Education:

Bachelor's (Required)

Experience:

supervisory: 3 years (Required)
regulated quality systems: 7 years (Required)

License/Certification:

ASQ certification (Preferred)

Ability to Commute:

Huntersville, NC 28078 (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality manager jobs in huntersville, nc

HAL Quality Manager

Quality Manager

Program Manager- Duke Lake Norman Quality Assurance

Quality Assurance Manager

Compliance Quality Assurance Manager (US)

Quality Manager

Automation Test Lead

Quality Manager (ISO 9001 / Metal Fabrication Manufacturing)

FSQA Supervisor

Sr. Director, Quality

Field Quality Manager - Michels Pipeline, Inc.

Quality Supervisor

Project Quality Completions Manager

Supervisor, Operations

Manager I, Quality

Manager, Quality Control

Quality Manager

Quality Assurance Quality Control (QA/QC) Manager

Corporate Quality Manager - Field Services

Quality Assurance/Quality Control Manager

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