Top 17531 Quality validation manager Jobs

Digital QA Manager
Guerbet —Raleigh, NC
- Full-time
- 8 years
- Mentoring
- Manufacturing
Quality Manager
Wiwynn International Corporation —El Paso, TX
- From $120,900 a year
- Overtime
- Spanish
- Schematics
- 5 years
- Health savings account
- Health insurance
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Director Quality and Performance Excellence
Community Hospital of Huntington Park —Huntington Park, CA
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- Customer service
- 5 years
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Quality Manager (Dist/Supply Chain)
AppleOne —Irving, TX
- $90,000 - $100,000 a year
- Oracle
- 5 years
- Engineering
- Dental insurance
- 401(k)
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Senior Manager
BMS —Princeton, NJ
- $164,110 - $198,862 a year
- Email
- Hybrid work
- Computer Science
- Master's degree
- SQL
- Paid holidays
- Disability insurance
Manager, GMP Quality
SimulStat —Remote
- Contract
- Bachelor's degree
- Senior level
- Communication skills
Senior Manager, Global Quality Assurance
Medexus Pharma —Remote
- Remote
- Microsoft Excel
- Master's degree
- 8 years
Quality Manager
Hill Data Management —New York, NY
- Part-time
- 7 years
- Bachelor's degree
- Quality control
Computer System Validation Lead / Program Manager
Veeva Systems —Remote
- $85,000 - $120,000 a year
- Full-time
- Remote
- Engineering
- 3 years
- Product management
- Paid holidays
- Health insurance
Quality Operations Program Manager - Document Control
Veeva Systems —Remote
- $100,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Health insurance
10d
Manager, Quality Assurance GMP
CG Oncology Inc —Remote
- $123,000 - $145,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Health savings account
- Disability insurance
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4d
Manager, GMP Quality Assurance, Clinical, QA
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 6 years
- Bachelor's degree
- Travel
- Health insurance
Manager/Sr. Manager, R&D Quality
TG Therapeutics —Remote
- Email
- Remote
- 5 years
- Analysis skills
- Bachelor's degree
QuickCode Quality Assurance Manager
Radformation —Remote
- $120,000 - $160,000 a year
- Full-time
- Remote
- 5 years
- Product management
- Senior level
- Paid holidays
- Disability insurance
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Manager Quality Assurance, Validation
Beckman Coulter Diagnostics —Chaska, MN
- $130,000 - $160,000 a year
- Full-time
- 7 years
- Master's degree
- Supervising experience
- Health insurance
- Dental insurance
Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)
Essenlix —Monmouth Junction, NJ
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Health insurance
- 401(k)
Quick Apply
Consultant - Validation Management Software
Veeva Systems —Remote
- $70,000 - $140,000 a year
- Full-time
- Up to 50% travel
- 3 years
- Travel
- Paid holidays
- Health insurance
Documentation Manager
Clinical Ink —Remote
- 5 years
- Bachelor's degree
- Organizational skills
Quick Apply
Sr. Design Quality Systems Manager
BD —San Diego, CA
- $158,300 - $261,100 a year
- Writing skills
- Office
- 3 years
Product Quality Manager
Upstart Network, Inc. —Remote
- $145,100 - $201,100 a year
- Remote
- Bachelor's degree
- Travel
- Experience equivalent to degree accepted
- Health savings account
- Employee stock purchase plan

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Digital QA Manager

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time

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

Apply Now

Refine Your Search

quality validation manager jobs

Digital QA Manager

Quality Manager

Director Quality and Performance Excellence

Quality Manager (Dist/Supply Chain)

Senior Manager

Manager, GMP Quality

Senior Manager, Global Quality Assurance

Quality Manager

Computer System Validation Lead / Program Manager

Quality Operations Program Manager - Document Control

Manager, Quality Assurance GMP

Manager, GMP Quality Assurance, Clinical, QA

Manager/Sr. Manager, R&D Quality

QuickCode Quality Assurance Manager

Manager Quality Assurance, Validation

Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)

Consultant - Validation Management Software

Documentation Manager

Sr. Design Quality Systems Manager

Product Quality Manager

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