QMS Architect

We need to output HTML fragment with sections only if real content. Must not repeat job title. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only if posting has real specific content. Let's parse the posting. Intro paragraph: "Is Kymanox the right fit for you? ..." This is like a motivational intro. Could be considered "About the role"? Probably we can put that under About the role. Then: "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." That's about the role. Then: "Employment Type Contract Position (3-Month Assignment) This position is a 3-month contract engagement focused on assessing, enhancing, and implementing Quality Management System processes and infrastructure within GMP-regulated pharmaceutical manufacturing environments." That could be under About the role or maybe a separate section like "Details". But we only have allowed headings; we could put under About the role. Then "Responsibilities" heading: list of responsibilities bullet points. Then "Education" heading: Bachelor's degree... Then "Qualifications" heading: 10+ years experience etc. Then "Aptitude And Skill Set": list of skills. Then "Region: RTP, NC" Then "Compensation": Hourly rate is commensurate with experience... This is vague; we should NOT include Pay section unless posting actually states them. It says "Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions." That's not a specific number or range; it's vague. According to rule: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. So we should NOT include Pay section. Benefits: none mentioned. Schedule: none mentioned. Thus we will have sections: About the role, Responsibilities, Education, Qualifications, Skills (Aptitude And Skill Set). Possibly also "Region" could be included under About the role or maybe as a short p. But we have no heading for region; we could embed in About the role paragraph. We must not include Job ID etc. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep all bullet points. We need to use

• for any list of duties/requirements/benefits. For Education and Qualifications maybe they are not lists but could be paragraphs. However Qualifications includes multiple bullet-like sentences; we could make a list. Education: "Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related discipline." That's a single sentence; we can put in

  . Qualifications: list of items: 10+ years experience..., Experience supporting GMP..., Demonstrated competency..., Demonstrated knowledge..., Experience supporting quality systems..., Experience with the implementation..., Familiarity..., Experience with pre-filled syringes..., Experience supporting commissioning..., etc. We'll make a

  . Skills: Aptitude And Skill Set list: many items; we can make a
  . Now we need to ensure we don't include boilerplate like EEO etc. At the end there is EEO statement; we must remove. Also remove "To learn more about our company, please visit our website: Life Science Solutions | Kymanox". That's boilerplate? It's company info but maybe considered substantive? It's about Kymanox; but it's not required? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The website link might be considered navigation? It's not exactly navigation but could be considered company info. However it's not a section heading; we could keep as part of About Kymanox paragraph? The section "About Kymanox" is descriptive; we could include that under About the role? Actually we have an "About Kymanox" paragraph after Compensation. That's substantive about the company. Could be included under About the role or maybe a separate section "About the company". But we only have allowed headings; we could put under About the role (makes sense). However we already have About the role content; we could add more paragraphs. We must not repeat the job title as a heading. The job title is "(Contract) QMS Architect". We must not use that as heading. Now produce HTML fragment. Structure:

  About the role

  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. This position is a 3-month contract engagement focused on assessing, enhancing, and implementing Quality Management System processes and infrastructure within GMP-regulated pharmaceutical manufacturing environments. Region: RTP, NC.

  Then Responsibilities:

  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.
  Education:

  Education

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

  Qualifications:

  Qualifications

  • 10+ years of experience working in quality, manufacturing, validation, facility operations, and/or quality systems within the pharmaceutical industry is required.
  • Experience supporting GMP-regulated manufacturing environments is strongly preferred.
  • 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.
  • 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.
  Skills:

  Skills

  • 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
  We should not include Pay/Benefits/Schedule sections. Check for any duplicated lines: we have not duplicated. Check for any boilerplate: we removed EEO, website link, etc. We kept "About Kymanox" description? Actually we omitted that paragraph about Kymanox company description. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "About Kymanox" paragraph is not boilerplate; it's substantive about the company. Should we keep it? It is substantive info about the company. Could be included under About the role or maybe a separate section but we don't have a heading for "About the company". We could incorporate it into About the role paragraph after the role description. Let's add a paragraph about Kymanox after the role description. We have already included some about Kymanox? Not yet. We need to incorporate the "About Kymanox