QMS Architect

Is Kymanox the right fit for you?

You want to make a difference and have an impact…

You enjoy having an influence in your day-to-day work…

You are motivated by working alongside a team filled with

subject matter experts who will help you learn and grow…

You wake up every day and do what you do

… because patients deserve better.

If this sounds like you, you’ve come to the right place.

The (Contract) QMS Architect
is responsible for designing, implementing, and maintaining Quality Management Systems (QMS) that support pharmaceutical manufacturing operations, facilities, utilities, and GMP-regulated environments. This role provides expertise in quality systems, compliance programs, and quality processes to ensure alignment with applicable regulatory requirements, including 21 CFR Parts 210 and 211. The QMS Architect will partner with internal and client teams to develop scalable quality infrastructure, support regulatory readiness, and drive continuous improvement initiatives.

Contract Position (3-Month Assignment)

This position is a3-month contract engagement
focused on assessing, enhancing, and implementing Quality Management System processes and infrastructure within GMP-regulated pharmaceutical manufacturing environments.

• Provides immediate supervision and leadership of direct reports within the team, if applicable.
• Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
• Implements and oversees Quality Management Systems relating to Change Control, Training, Document Control, Deviations and Investigations, Nonconformances, Complaints, CAPA, and other quality system elements.
• Develops, implements, and maintains quality policies, procedures, work instructions, and forms for both clients and Kymanox.
• Develops training content and deploys training for quality management systems, GMP requirements, regulatory requirements, and industry best practices. Maintains written procedures for personnel qualification and training.
• Completes gap assessments against applicable pharmaceutical manufacturing regulations and industry standards, including 21 CFR Parts 210 and 211, GMP requirements, and other relevant FDA and ISO regulations.
• Responsible for the maintenance, implementation, and oversight of electronic Quality Management Systems (eQMS) and Electronic Document Management Systems (EDMS) both internally and externally.
• Provides strategic plans for the design, development, and continuous improvement of quality system infrastructure and company compliance programs.
• Provides subject matter expertise related to pharmaceutical manufacturing operations, facility systems, critical utilities, commissioning, qualification, validation, and GMP compliance.
• Supports quality oversight and compliance activities associated with manufacturing facilities, clean rooms, HVAC systems, water systems, equipment qualification, and other critical GMP utilities.
• Conducts audits as Lead Auditor and Support Auditor.
• Participates in regulatory inspections, audit readiness activities, remediation efforts, and regulatory response initiatives.
• Follows policies and standard operating procedures to support internal and client projects.
• May support supply chain and vendor management strategy, supplier qualification, and compliance activities.
• Completes assigned training requirements (internal and external).
• May provide technical project management, meeting facilitation, and cross-functional leadership.

Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related discipline.

• 10+ years of experience working in quality, manufacturing,…