Quality Systems Manager
About this opportunity
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Quality Systems
Job Category:
People Leader
All Job Posting Locations:
Huejotzingo, Puebla, Mexico
Job Description:
Position Summary
Quality Assurance / Quality Systems Manager lead and continuously improve the Quality Management System (QMS). This role combines strategic ownership of quality systems (e.g., eQMS, CAPA, change control, document control) with hands-on operational oversight of compliance, audits, supplier quality, and product release activities. The ideal candidate is a systems thinker who partners cross-functionally to reduce risk, increase product and process robustness, and embed a culture of quality.
Key Responsibilities
Own, maintain, and continuously improve the Quality Management System to meet internal requirements and applicable regulatory standards (e.g., ISO 9001, ISO 13485, 21 CFR Part 820, GMP, or industry-specific standards as relevant).
Lead the administration and optimization of digital QMS tools: document management, CAPA, nonconformance, change control, training, audit management, and supplier quality modules.
Manage CAPA lifecycle: root cause analysis, corrective actions, validation of effectiveness, and closure with evidence-based controls.
Oversee product release, lot disposition, and quality review processes; ensure timely and compliant product commercialization.
Lead supplier quality activities: qualification, monitoring, performance metrics, and remediation plans.
Drive change control and risk management processes; perform or review risk assessments (e.g., FMEA, risk registers) and ensure mitigation actions are implemented.
Establish and report meaningful quality KPIs and dashboards (e.g., CAPA cycle time, audit findings trend, supplier PPM, customer complaints, deviation rates).
Provide leadership, coaching, and training on QA processes and QMS usage to cross-functional teams.
Maintain document control: policies, SOPs, batch records, specifications, and quality records with current revision control.
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field; advanced degree preferred. Pharmaceutical: Chemist-Biologist, Pharmaceutical Engineer or Industrial Pharmaceutical Chemist.
8+ years of progressive quality systems experience; or 5+ years in managerial role ( medical devices, pharma, biotech, CPG, manufacturing).
Business English proficiency.
Preferred
Certification: ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
Experience with Lean, Six Sigma (Green/Black Belt), or other continuous improvement methodologies.
Experience in supplier audits and vendor management, including international suppliers.
Prior experience in regulatory inspection readiness and successful management of regulatory responses.
Core Competencies & Skills
Leadership: ability to influence without authority; coach teams to adopt quality practices.
Communication: clear written and verbal communication for technical and non-technical audiences; able to write concise CAPA reports and audit responses.
Project management: ability to manage multiple projects, prioritize, and meet deadlines.
Attention to detail and organizational discipline.
Problem solving: structured and evidence-based approach to troubleshooting and preventive action.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
Required Skills:
Preferred Skills:
Analytical Reasoning, Analytics Dashboards, Collaboration, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Technical Credibility
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 221 comparable Manager Quality roles across 59 biopharma companies.
Salary context
65 of 221 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 221 comparable roles
+ 21 more countries
Seniority mix
221 of 221 peers have a known seniority level
Therapeutic area mix
0 of 221 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.