QMS Architect

Kymanox • Morrisville, NC

9d • Hybrid

About The Position

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.

Requirements

• 10+ years of experience working in quality, manufacturing, validation, facility operations, and/or quality systems within the pharmaceutical industry is required.
• Demonstrated competency in quality system elements, including CAPA, Deviations and Investigations, Document Control, Training, Supplier Management, Auditing, Change Control, Complaints/Recalls, Validation, Management Review, and Risk Management.
• Demonstrated knowledge of pharmaceutical manufacturing processes and GMP requirements under 21 CFR Parts 210 and 211.
• Experience supporting quality systems and compliance programs for manufacturing facilities, cleanrooms, HVAC systems, water systems, equipment qualification, utilities, and other critical GMP infrastructure.
• Experience with the implementation, training, use, and oversight of EDMS and eQMS systems.
• Familiarity with risk management tools, data analysis tools, and quality metrics.
• Versatile and adaptable technical skills
• Positive attitude, and welcomes new challenges
• Flexible to be present at client sites and sometimes travel
• Able to execute activities with minimal supervision, manages time wisely
• Strong professional presence and presentation skills
• Extremely detail-orientated and highly organized
• Excellent written and oral English communication skills
• Comfortable providing feedback and influencing internal and external stakeholders
• Emotionally stable and can navigate challenging clients and situations
• Seasoned soft skills – high EQ and team player
• Ability to work effectively with remote team members
• Tackle problems proactively
• A mindset of innovation and creativity
• Computer and IT savvy
• Thrive in a fast-paced, growing, and dynamic work environment
• Expertly solicit and utilize subject matter expert input
• Value and understand quality
• Uncompromised honesty and integrity

Nice To Haves

• Experience supporting GMP-regulated manufacturing environments is strongly preferred.
• Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or combination product platforms is desired.
• Experience supporting commissioning, qualification, validation, inspection readiness, and regulatory compliance initiatives is preferred.

Responsibilities

• 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, cleanrooms, 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.

Benefits

• Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior