Senior Quality Systems Leader

Biopharma Asia; Añasco (PR); On-site; USD 120,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Systems for the Anasco, PR site. You will lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.

You will act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, driving product quality, patient safety, and regulatory readiness.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• Minimum 8 years of progressive experience in quality systems within regulated industries.
• In-depth knowledge of cGMP, 21 CFR 210/211/820, ISO 13485, ICH Q10.
• Experience with eQMS platforms (EtQ, TrackWise) and quality metrics/reporting tools.
• Experience with change control or PLM systems (Agile, Windchill).
• Strong CAPA management and investigation governance.

Responsibilities

• Own and continuously improve the QMS to align with regulatory requirements.
• Lead CAPA, nonconformance, deviation, change control, and recall readiness processes.
• Develop and maintain a risk-based quality approach (FMEA, QRM).
• Oversee internal and supplier audits; plan, coordinate, and close findings.
• Support supplier qualification and ongoing supplier quality oversight.
• Ensure document and record control, release processes, and eQMS optimization.
• Provide quality support for manufacturing transfers and process validation/changes.
• Coach site quality teams and cross-functional partners on quality expectations.

Skills

CAPA management

Regulatory compliance

Quality management systems

Change control

Data quality

Leadership

Risk management

System integration

Education

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

Advanced degree preferred

Tools

EtQ

TrackWise

Agile

Windchill

Job description

Johnson & Johnson is seeking a Senior Manager, Quality Systems for the Anasco, PR site. You will lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.

You will act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, driving product quality, patient safety, and regulatory readiness.