Quality Management Systems Jobs
Quality Management Systems jobs are open across manufacturing, pharmaceuticals, aerospace, medical devices, and healthcare, at levels from quality technician to director, with specializations in ISO compliance, process improvement, and regulatory affairs. Find a role that fits from the openings below and apply directly.
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Description:
The Manager – Quality Management Systems & Compliance is responsible for end-to-end ownership of the Quality Management System (QMS) at an Oral Solid Dosage manufacturing site. This role ensures sustained compliance with global regulatory requirements (FDA, EMA, MHRA, ICH) and drives continuous improvement through robust risk management, and data-driven quality oversight. The position requires strong leadership in managing planned/unplanned deviations, CAPA, change controls, and audit readiness, while partnering cross-functionally to ensure product quality and regulatory compliance. The Manager, Quality Systems may also manage other quality assurance professional staff, and/or quality assurance programs and projects, and interfaces with both internal and external senior managers in operations and QA to ensure full compliance with FDA GMP standards and regulations. Influencing stakeholders and partners, and effectively recommending solution/options to complex quality assurance issues is required.
Essential Functions:
- Own and manage site QMS elements including Change Control, Deviations, CAPA, OOS, Complaints ensuring timely closure and compliance with cGMP
- Lead and approve complex investigations ensuring scientifically justified root cause analysis and implementation of effective CAPAs
- Ensure continuous audit readiness; act as SME during regulatory inspections and customer audits; lead response preparation and closure
- Establish and monitor quality metrics; perform trend analysis for deviations, CAPA, complaints, and OOS to drive continuous improvement
- Implement Quality Risk Management (ICH Q9) across QMS processes and product lifecycle
- Oversee quality compliance during new product introduction (NPI), validation, and commercialization activities
- Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests, or by any other statistical tools.
- Act as SME for electronic QMS systems (Caliber,ValGenesis, SAP, etc.) and drive digitalization initiatives
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations. Collaborate with cross-functional teams (Manufacturing, QC, Validation, Supply Chain) to resolve quality issues and ensure compliance
Additional Responsibilities:
- Participates in FDA inspections as required. Support internal audits and self-inspection programs
- Support QM Director with interaction with regulators during site inspections relative to GMP facility areas and equipment; support successful management of inspections
- Support quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance. Ensure commitments to regulatory agencies are tracked and met
- Train and develop QA and other Operations staff in relevant technical subjects, and is a key contributor to GMP training activities
- Review and approve SOPs, protocols, reports, and quality documentation
- Drive continuous improvement initiatives aligned with corporate quality strategy
- Perform other duties as assigned
Education:
- Bachelors Degree (BA/BS) Pharmacy, Chemistry, Biotechnology, or related field - Required Master Degree (MS/MA) Pharmacy, Chemistry, Biotechnology, or related field - Preferred
Experience:
5-7 years experience in GMP quality assurance supporting pharmaceutical manufacturing systems with supervisory/management experienceSpecialized Knowledge:
- An advanced knowledge of FDA and other relevant Regulatory agency policies/procedures
- ICH Guidelines (Q7, Q9, Q10)
- Data Integrity principles Electronic Quality Management Systems (eQMS)
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $130,000 to $140,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
Description:
The Manager – Quality Management Systems & Compliance is responsible for end-to-end ownership of the Quality Management System (QMS) at an Oral Solid Dosage manufacturing site. This role ensures sustained compliance with global regulatory requirements (FDA, EMA, MHRA, ICH) and drives continuous improvement through robust risk management, and data-driven quality oversight. The position requires strong leadership in managing planned/unplanned deviations, CAPA, change controls, and audit readiness, while partnering cross-functionally to ensure product quality and regulatory compliance. The Manager, Quality Systems may also manage other quality assurance professional staff, and/or quality assurance programs and projects, and interfaces with both internal and external senior managers in operations and QA to ensure full compliance with FDA GMP standards and regulations. Influencing stakeholders and partners, and effectively recommending solution/options to complex quality assurance issues is required.
Essential Functions:
- Own and manage site QMS elements including Change Control, Deviations, CAPA, OOS, Complaints ensuring timely closure and compliance with cGMP
- Lead and approve complex investigations ensuring scientifically justified root cause analysis and implementation of effective CAPAs
- Ensure continuous audit readiness; act as SME during regulatory inspections and customer audits; lead response preparation and closure
- Establish and monitor quality metrics; perform trend analysis for deviations, CAPA, complaints, and OOS to drive continuous improvement
- Implement Quality Risk Management (ICH Q9) across QMS processes and product lifecycle
- Oversee quality compliance during new product introduction (NPI), validation, and commercialization activities
- Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests, or by any other statistical tools.
- Act as SME for electronic QMS systems (Caliber,ValGenesis, SAP, etc.) and drive digitalization initiatives
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations. Collaborate with cross-functional teams (Manufacturing, QC, Validation, Supply Chain) to resolve quality issues and ensure compliance
Additional Responsibilities:
- Participates in FDA inspections as required. Support internal audits and self-inspection programs
- Support QM Director with interaction with regulators during site inspections relative to GMP facility areas and equipment; support successful management of inspections
- Support quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance. Ensure commitments to regulatory agencies are tracked and met
- Train and develop QA and other Operations staff in relevant technical subjects, and is a key contributor to GMP training activities
- Review and approve SOPs, protocols, reports, and quality documentation
- Drive continuous improvement initiatives aligned with corporate quality strategy
- Perform other duties as assigned
Education:
- Bachelors Degree (BA/BS) Pharmacy, Chemistry, Biotechnology, or related field - Required Master Degree (MS/MA) Pharmacy, Chemistry, Biotechnology, or related field - Preferred
Experience:
5-7 years experience in GMP quality assurance supporting pharmaceutical manufacturing systems with supervisory/management experienceSpecialized Knowledge:
- An advanced knowledge of FDA and other relevant Regulatory agency policies/procedures
- ICH Guidelines (Q7, Q9, Q10)
- Data Integrity principles Electronic Quality Management Systems (eQMS)
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $130,000 to $140,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
Quality Management Systems Jobs by Experience Level
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Find JobsQuality Management Systems Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Medical Devices
- Science & Research
- Electronics & Hardware
- Consulting & Professional Services
What Employers Look For
The qualifications that appear most often in quality management systems jobs.
- Hands-on experience implementing or maintaining ISO 9001 or industry-specific quality standards
- Proficiency with QMS software platforms such as MasterControl, Veeva Vault, or ETQ Reliance
- Experience leading internal and external audits and managing corrective and preventive actions
- Bachelor's degree in engineering, science, supply chain, or a related technical field
- Certified Quality Engineer, Certified Quality Manager, or Certified Quality Auditor credential from ASQ
- Familiarity with risk management frameworks such as FMEA and experience with root cause analysis tools
Tips for Your Quality Management Systems Job Search
Tailor your resume to specific standards
List the exact standards you've worked with, such as ISO 9001, AS9100, or 21 CFR Part 820, in your resume's skills section. Recruiters scan for these abbreviations first, so burying them in bullet points under each job often isn't enough.
Quantify audit and corrective action outcomes
Quality management systems hiring managers want evidence of impact, not just process ownership. Describe how many audits you led, how quickly CAPAs closed, or what defect rate you reduced, even if the figures are modest.
Filter openings by your certification tier
Job postings often separate roles requiring CQE, CQM, or CQA credentials from those that only prefer them. Apply early to roles where your current certification matches the required level and build your pipeline from there.
Apply early to roles that fit
Migrate Mate lists quality management systems openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Prepare for document control scenario questions
Interviewers frequently present a real or hypothetical document control failure and ask how you'd respond. Practice walking through your nonconformance and CAPA process step by step, referencing the specific QMS software you've used, such as MasterControl or Veeva Vault.
Negotiate using scope of system responsibility
When discussing offers, frame your value around the scale of the QMS you've managed, including number of sites, product lines, or regulated categories. Employers in heavily regulated industries price this scope directly into compensation bands.
Quality Management Systems Jobs: Frequently Asked Questions
Which companies are hiring the most quality management systems professionals?
The companies hiring the most quality management systems professionals right now include Intellia, Dyne Therapeutics, and Intellia Therapeutics, with the largest share of openings in Massachusetts, New York, and Wisconsin, based on current listings on Migrate Mate as of August 2026. Demand is concentrated in manufacturing, medical device, and pharmaceutical employers subject to strict regulatory oversight.
How many quality management systems jobs are remote?
About 42% of quality management systems openings are fully remote or hybrid as of August 2026, which is lower than many professional roles because on-site audits and production floor oversight are core responsibilities. Remote and hybrid arrangements are most common for quality systems analysts, document control specialists, and supplier quality roles that are primarily desk-based.
How do you become a quality management systems professional?
Start by earning a bachelor's degree in engineering, life sciences, or supply chain, then build hands-on experience in a quality technician or inspector role. Pursue an ASQ certification such as the Certified Quality Engineer or Certified Quality Auditor to signal formal competency. Practice with at least one major QMS software platform and complete internal auditor training to qualify for mid-level roles.
Can you get a quality management systems job with little experience?
Yes, entry-level quality roles such as quality technician, document control coordinator, or quality inspector are common stepping stones that don't require years of QMS experience. Employers in these roles look for attention to detail, familiarity with basic quality tools like fishbone diagrams and control charts, and a willingness to learn audit procedures. An ASQ Certified Quality Improvement Associate credential can strengthen an entry-level application.
What does the quality management systems interview process look like?
Most hiring processes include a phone screen focused on your experience with specific standards and audit history, followed by a technical interview where you walk through a past CAPA or nonconformance case in detail. A final round often involves meeting cross-functional stakeholders from operations or regulatory affairs. Some employers add a practical exercise such as reviewing a mock procedure document and identifying gaps.
Where can I find and apply to quality management systems jobs?
You can find and apply to quality management systems jobs on Migrate Mate, which lists current openings from employers across the United States. Search the listings to find roles that match your certification level, industry background, and preferred location, then apply directly to each one that fits.
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