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Manager Gmp Quality Assurance Jobs (NOW HIRING)

LeadStack Inc.

GMP QA Validation Specialist

Durham, NC · On-site

$45 - $53/hr

... GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be ... This role will assist in the management of Quality Management System (QMS) and will strongly ...

LeadStack Inc.

GMP QA Validation Specialist

Durham, NC · On-site

$45 - $53/hr

... GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be ... This role will assist in the management of Quality Management System (QMS) and will strongly ...

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How much do manager gmp quality assurance jobs pay per year?

As of Aug 20, 2026, the average yearly pay for manager gmp quality assurance in the United States is $118,074.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,000.00 and $144,500.00 per year, depending on experience, location, and employer.

What are the responsibilities of a Manager GMP Quality Assurance?

A Manager GMP (Good Manufacturing Practice) Quality Assurance oversees compliance with regulatory and company quality standards for pharmaceutical or biotech manufacturing. They develop, implement, and monitor quality management systems, manage audits and inspections, and ensure that all processes align with GMP guidelines. This role often involves training staff, investigating quality issues, and working closely with other departments to maintain product safety and integrity.

What are the key skills and qualifications needed to thrive as a Manager GMP Quality Assurance?

To thrive as a Manager GMP Quality Assurance, you need a strong understanding of Good Manufacturing Practices (GMP), quality systems, and regulatory compliance, typically supported by a degree in life sciences or a related field. Familiarity with quality management systems (QMS), audit processes, and industry-specific standards such as FDA or EMA regulations is crucial, and certifications like ASQ Certified Quality Auditor can be beneficial. Leadership, attention to detail, and effective communication are valuable soft skills for managing teams and ensuring compliance. These competencies are essential for maintaining product quality, regulatory adherence, and the reputation of the organization.

What are some common challenges faced by a Manager GMP Quality Assurance, and how can they be addressed?

A Manager GMP Quality Assurance often faces challenges such as staying up-to-date with evolving regulatory requirements, managing cross-functional teams, and ensuring consistent compliance across all processes. Balancing the demands of production schedules with the need for thorough documentation and quality checks can also be demanding. To address these challenges, it is essential to foster a culture of open communication, provide regular training for staff, and implement robust internal audit systems to identify and correct issues proactively.

What is the difference between Manager Gmp Quality Assurance vs Quality Assurance Specialist?

AspectManager Gmp Quality AssuranceQuality Assurance Specialist
CertificationsGMP certifications, QA certificationsGMP certifications, QA certifications
Work EnvironmentOversees QA teams in pharmaceutical/biotech companiesSupports QA activities under supervision in similar settings
ResponsibilitiesDevelops QA strategies, manages teams, ensures GMP compliancePerforms QA testing, audits, and documentation tasks

The main difference is that the Manager Gmp Quality Assurance holds a leadership role, overseeing QA teams and strategic compliance, while the Quality Assurance Specialist focuses on executing QA tasks and supporting the QA process. Both roles require GMP knowledge and certifications, but the manager has broader responsibilities and leadership duties.

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Manager Gmp Quality Assurance jobs near you
Infographic showing various Manager Gmp Quality Assurance job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

GMP QA Validation Specialist

LeadStack Inc.

Durham, NC • On-site

$45 - $53/hr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

QA Validation Specialist

Location: Research Triangle Park, NC – 27709 Duration: 10 Months Pay Rate: $45/hr - $53/hr on W2

The Validations Contractor – GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Acting as a key QA partner to technical and operational teams, this role will provide expert oversight and quality support throughout the lifecycle of validation activities, from planning and development through execution and final approval. This role will assist in the management of Quality Management System (QMS) and will strongly support Culture of Quality. The position will be based at our headquarters facility in RTP, NC with no travel expected.

Job Responsibilities

  • Work alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.
  • Provide timely quality support and thorough reviews and approvals of various records including, but not limited to; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations and Corrective Action/Preventive Action (CAPAs).
  • Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.
  • Report on applicable key metrics to drive continuous improvement in compliance.
  • Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.
  • Maintain Quality Systems in support of QMS and GMPs, including:
    • Support equipment and computer system qualification and validation activities and vendor management program.
    • Review and approve SOP drafts and revisions.
    • Support, review and approve assigned change control records.
  • Communicate project status to stakeholders and escalate issues in a timely manner.
  • Support ongoing Computerized Maintenance Management System records, including review and approval of work order records.

About You

Bachelor's degree in a scientific field.

5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.

Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.

Strong technical understanding of equipment and system validation principles.

Ability to author, review, and interpret Standard Operating Procedures (SOPs).

Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.

Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.

Ability to manage workload effectively in order to meet project timelines.

Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues across a dynamic GMP environment.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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