Senior Manager, Quality Systems: Regulatory QMS Lead

7239-AMO Puerto Rico Manufacturing Inc. Legal Entity; Puerto Rico; On-site; USD 120,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Systems to lead the design, implementation, maintenance and continuous improvement of the site Quality Management System at the Anasco, PR site. You will act as SME for Quality Systems across development, manufacturing and supply chain, ensuring product quality and regulatory readiness.

The role requires 8+ years in quality systems within regulated industries, deep cGMP knowledge, and experience with eQMS platforms.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 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) and quality metrics/reporting tools.
• Experience with change control or PLM systems (Agile, Windchill).
• Strong leadership and people management skills; ability to influence without authority.
• Excellent written and verbal communication; able to present to senior leadership and cross-functional teams.

Responsibilities

• Own and continuously improve the QMS to align with cGxP expectations and corporate requirements.
• Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation and remediation.
• Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into decisions.
• Oversee internal and supplier audit programs; plan, coordinate, and lead audits and close findings.
• Support supplier qualification and ongoing supplier quality oversight, including audits and corrective actions.
• Ensure effective document and record control, release processes, and eQMS utilization.
• 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.
• Prepare and present quality metrics and dashboards to site leadership; drive data-driven improvement.
• Interface with regulatory agencies during inspections and submissions; manage reports.
• Manage, hire, and develop direct reports; foster accountability and continuous learning.

Skills

Quality Systems Leadership

CAPA management

Regulatory compliance

Cross-functional collaboration

Data-driven decision making

Strong communication

Education

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

Advanced degree preferred

Tools

EtQ TrackWise eQMS

Quality metrics tools

PLM systems (Agile, Windchill)

Job description

Johnson & Johnson is seeking a Senior Manager, Quality Systems to lead the design, implementation, maintenance and continuous improvement of the site Quality Management System at the Anasco, PR site. You will act as SME for Quality Systems across development, manufacturing and supply chain, ensuring product quality and regulatory readiness.

The role requires 8+ years in quality systems within regulated industries, deep cGMP knowledge, and experience with eQMS platforms.