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Vor Bio

Quality Systems Manager

Boston, MA · Remote

$170K - $180K/yr

The individual will possess a strong hands-on expertise in GxP quality systems and operations within the biotech industry. Key Responsibilities * Documentation Management: Perform document control ...

Vor Bio

Quality Systems Manager

Boston, MA · On-site

The individual will possess a strong hands-on expertise in GxP quality systems and operations within the biotech industry. Key Responsibilities * Documentation Management: Perform document control ...

Aspen Neuroscience

Sr. Manager, QA

San Diego, CA · Hybrid

The Senior Manager, Quality Assurance leads the execution, maintenance, and ongoing improvement of GxP quality systems and teams that support Phase 2a through Phase 3 clinical and manufacturing ...

Aspen Neuroscience

Sr. Manager, QA

San Diego, CA · On-site

$160K - $186K/yr

The Senior Manager, Quality Assurance leads the execution, maintenance, and ongoing improvement of GxP quality systems and teams that support Phase 2a through Phase 3 clinical and manufacturing ...

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How much do gxp quality systems jobs pay per hour?

As of Jul 5, 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 June 2026, with employment types broken down into 100% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $53,326 per year, or $25.6 per hour.

Manager, GxP Quality Systems

Kailera Therapeutics, Inc.

Waltham, MA

Other

Posted yesterday

Job description

What You'll Do:

The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

  • Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.)
  • Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings
  • Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests
  • Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems
  • Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator
  • Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence
  • Evaluate opportunities for continuous improvements across the systems
  • Work with stakeholders to ensure appropriate documentation of Service Provider selection, qualification, and evaluation/requalification
  • Support development of metrics related to Service Provider qualifications and Service Provider Quality Events
  • Manage and track Audit Schedule ensuring adherence to Audit Program and timeliness of deliverables

Required Qualifications:

  • Minimum of 6+ years of experience in FDA regulated industry
  • Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
  • A strong customer focus and ability to prioritize and adapt to business needs are required
  • Strong business partner with all Functional Areas to ensure efficient collaboration and to drive results
  • Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
  • Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards
  • Clear, concise writing skills and good verbal communication and presentation skills

Education:

  • Bachelor's degree in Life Sciences or a related field

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