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Gxp Quality Systems Jobs (NOW HIRING)

Care Access

Manager, Quality Assurance

Charleston, WV · On-site

Quality at Care Access is built on strong systems and even stronger accountability, supported by ... Internal Auditing: independently lead and conduct internal audits and related GxP activities ...

Care Access

Manager, Quality Assurance

Quality at Care Access is built on strong systems and even stronger accountability, supported by ... Internal Auditing: independently lead and conduct internal audits and related GxP activities ...

Care Access

OR

Quality at Care Access is built on strong systems and even stronger accountability, supported by ... Internal Auditing: independently lead and conduct internal audits and related GxP activities ...

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How much do gxp quality systems jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for gxp quality systems in the United States is $25.64, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $28.85 per hour, depending on experience, location, and employer.

How does a GxP Quality Systems professional typically interact with cross-functional teams to ensure compliance?

GxP Quality Systems professionals regularly collaborate with departments such as manufacturing, regulatory affairs, IT, and R&D to ensure that all processes and documentation meet regulatory compliance standards. This often involves leading or participating in audits, facilitating training sessions, and supporting the implementation of corrective and preventive actions (CAPAs). Effective communication and project management skills are crucial, as the role requires coordinating efforts among diverse teams to maintain consistent quality practices across the organization.

What are the key skills and qualifications needed to thrive in GxP Quality Systems, and why are they important?

To thrive in GxP Quality Systems, you need a solid understanding of regulatory compliance (GMP, GLP, GCP), quality management principles, and often a background in life sciences or related fields. Familiarity with electronic quality management systems (eQMS), document control software, and relevant certifications such as Six Sigma or ASQ are commonly required. Strong attention to detail, problem-solving skills, and the ability to communicate effectively across departments are crucial soft skills. These competencies ensure that organizations maintain compliance with industry regulations, minimize risks, and uphold product quality and safety.

What are GxP Quality Systems?

GxP Quality Systems refer to a set of guidelines and regulations that ensure the quality, safety, and integrity of products and processes in the life sciences industry. 'GxP' stands for 'Good Practice' with the 'x' representing different fields such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). These systems are designed to maintain compliance with regulatory requirements, prevent errors, and ensure products are consistently produced and controlled to high standards. Implementing GxP Quality Systems helps organizations avoid costly recalls, legal issues, and protects patient safety.
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Gxp Quality Systems jobs near you
Infographic showing various Gxp Quality Systems job openings in the United States as of May 2026, with employment types broken down into 94% Full Time, and 6% Part Time. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $53,326 per year, or $25.6 per hour.
Quality Systems Specialist

Quality Systems Specialist

Kindeva Drug Delivery

Lexington, KY • On-site

Full-time

Posted 10 days ago

Job description

Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
As a Quality Systems Specialist, you will play a critical role in ensuring quality oversight and compliance across pharmaceutical development, manufacturing, and testing. This position is responsible for supporting and maintaining quality systems, overseeing supplier quality programs, coordinating audits and compliance activities, and driving continuous improvement initiatives to ensure adherence to applicable regulatory requirements and company standards. You will collaborate closely with internal departments and external partners to strengthen quality processes, support inspections and audits, and contribute to the overall success of Kindeva's Quality organization.
Responsibilities
Quality Systems & Compliance
  • Support the development, maintenance, and continuous improvement of quality systems to ensure compliance with current Good Manufacturing Practices (cGMPs), Good Practice (GxP) requirements, 21 CFR Part 11, and other applicable regulations.
  • Review and approve quality documentation, including procedures, validation protocols, development reports, product complaint investigations, and other compliance-related records.
  • Develop and maintain compliance metrics, trending reports, and quality system monitoring activities to support regulatory readiness and continuous improvement.

Supplier Quality & Audit Support
  • Manage supplier quality activities, including supplier qualifications, Supplier Corrective Action Requests (SCARs), vendor change notifications, supplier quality agreements, and related quality assessments.
  • Participate in and support internal audits, supplier audits, customer audits, regulatory inspections, and compliance assessments while providing recommendations and implementing improvements as appropriate.
  • Collaborate with internal departments and external suppliers to address quality concerns and ensure ongoing compliance with company and regulatory expectations.

Project Leadership & Cross-Functional Support
  • Lead or support quality-related projects and continuous improvement initiatives designed to enhance the effectiveness and efficiency of quality systems and processes.
  • Partner with Quality, Manufacturing, Technical Operations, and other functional teams to support business objectives, investigations, and compliance activities.
  • Utilize electronic Quality Management Systems (eQMS) to support quality system processes and assist management with departmental priorities and special projects.

Qualifications
  • Bachelor's degree or equivalent experience with a minimum of 3 years of pharmaceutical or medical device quality experience in a current Good Manufacturing Practice (cGMP) environment.
  • Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology, or medical device environments.
  • Demonstrated ability to assess problems, identify solutions, implement corrective actions, manage multiple priorities, and meet established timelines in a fast-paced environment.
  • Strong communication, collaboration, and technical writing skills with the ability to work effectively both independently and within cross-functional teams.
  • Experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva preferred. Experience supporting internal and external quality systems activities is highly desirable. Must be qualified to work with controlled substances.

Physical Requirements
  • Ability to regularly use computers, electronic systems, and training materials for extended periods of time.
  • Ability to effectively communicate through both telephone and electronic means.
  • Ability to regularly stand and walk for extended periods throughout the workday.
  • Must occasionally lift and/or move up to 25 pounds.
  • Ability to use proper lifting techniques, remain aware of workplace hazards, and follow all site safety procedures.

#LI-Onsite
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

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