Senior Quality Systems Leader — MedTech & Compliance

J&J Family of Companies; Añasco (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson in Puerto Rico (Añasco) is seeking a Senior Manager, Quality Systems to lead the design, implementation, and continuous improvement of the site Quality Management System (QMS) ensuring compliance with regulatory standards.

As a subject matter expert, you will drive CAPA, change control, supplier quality oversight, audits, and regulatory inspections readiness, while coaching cross-functional teams and delivering data-driven quality metrics to site leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• Minimum 8 years of progressive experience in quality systems within pharmaceutical, biotech, medical device, or regulated industries.
• In-depth knowledge of cGMP, 21 CFR Part 210/211/820 (as applicable), ISO 13485 (if medical device), ICH Q10, and other relevant regulations and guidance.
• Proven experience with eQMS platforms (EtQ, TrackWise, etc) and quality metrics/reporting tools.
• Experience with change control or PLM systems (Agile, Windchill, etc).
• Strong experience in CAPA management, root-cause analysis techniques (5 Whys, RCA, fishbone), and investigation governance.
• Demonstrated experience leading audits and interacting with regulatory inspectors.

Responsibilities

• Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
• Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
• Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
• Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
• Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
• Ensure effective document and record control, release processes, and electronic QMS (eQMS) utilization and optimization.
• Provide quality support for manufacturing transfers, scale-up, technology transfers, and process validation/changes.
• Coach and mentor site quality teams and cross-functional partners on quality system expectations, investigations best practices, and compliance culture.
• Prepare and present quality metrics and dashboards to site leadership; drive data-driven continuous improvement.
• Interface with regulatory agencies during inspections and regulatory submissions as required.
• Manage, hire, and develop direct reports (if applicable); foster a culture of accountability and continuous learning.

Skills

CAPA management

Root-cause analysis

Audit leadership

Regulatory inspections

Quality systems

eQMS (EtQ/TrackWise)

Change control

PLM systems

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Advanced degree preferred

Tools

EtQ

TrackWise

Agile

Windchill

Job description

Johnson & Johnson in Puerto Rico (Añasco) is seeking a Senior Manager, Quality Systems to lead the design, implementation, and continuous improvement of the site Quality Management System (QMS) ensuring compliance with regulatory standards.

As a subject matter expert, you will drive CAPA, change control, supplier quality oversight, audits, and regulatory inspections readiness, while coaching cross-functional teams and delivering data-driven quality metrics to site leadership.