Senior Manager, Quality Systems

Johnson & Johnson Innovative Medicine • Añasco, PR

1d • Onsite

About The Position

Johnson & Johnson is seeking a Senior Manager, Quality Systems, located in Añasco, Puerto Rico. The role leads the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS), ensuring compliance with applicable regulations and corporate quality standards. The position serves as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities to support product quality, patient safety, and regulatory readiness.

The role oversees core quality-system processes, including CAPA, nonconformance, deviation, change control, complaint handling, audit readiness, supplier quality, document control, and electronic QMS utilization. It integrates risk management into product and process decisions, supports manufacturing and technology transfers, scale-up, and process validation, and drives data-informed continuous improvement through quality metrics. The Senior Manager coaches site quality teams and cross-functional partners, interacts with regulatory agencies during inspections and submissions as needed, and manages, hires, and develops direct reports if applicable.

The role requires presence in offices and on the manufacturing floor, with PPE and site access governed by safety protocols. Occasional travel to domestic sites and suppliers, and for regulatory inspections, may be required. The position requires integrity, compliance with standards, and the ability to work in a regulated environment.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• At least 8 years of progressive experience in quality systems within pharmaceutical, biotech, medical device, or other 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 such as EtQ or TrackWise and with quality metrics and reporting tools.
• Experience with change control or PLM systems such as Agile or Windchill.
• Strong experience in CAPA management, root-cause analysis techniques such as 5 Whys, RCA, and fishbone, and investigation governance.
• Demonstrated experience leading audits and interacting with regulatory inspectors.
• Office and manufacturing-floor presence, with PPE and site access in accordance with safety protocols.
• Demonstrated integrity, adherence to compliance standards, and ability to operate in a regulated environment.

Nice To Haves

• Advanced degree.
• Experience with Lean, Six Sigma, or continuous improvement methodologies; certification preferred.
• Prior experience in supplier quality management and audit programs.
• Familiarity with validation strategies for processes, equipment, and computerized systems.
• Experience leading cross-functional change control and product transfer activities.
• Strong leadership and people-management skills, including the ability to influence without authority.
• Excellent written and verbal communication skills and ability to present to senior leadership and cross-functional teams.
• Analytical thinking, strong problem-solving skills, and attention to detail.
• Project and stakeholder management skills, including the ability to prioritize and deliver results in a matrix environment.
• Commitment to building a culture of quality and compliance.

Responsibilities

• Own and continuously improve the QMS, including policies, SOPs, work instructions, and records, to align with cGxP expectations and corporate requirements.
• Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall-readiness processes; ensure timely investigations, root-cause analysis, and effective remediation.
• Develop and maintain a risk-based quality approach, including FMEA and 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 utilization and optimization of the electronic QMS.
• Provide quality support for manufacturing transfers, scale-up, technology transfers, and process validation and changes.
• Coach and mentor site quality teams and cross-functional partners on quality-system expectations, investigation practices, and compliance culture.
• Prepare and present quality metrics and dashboards to site leadership and drive data-driven continuous improvement.
• Interface with regulatory agencies during inspections and regulatory submissions as required.
• Manage, hire, and develop direct reports, if applicable, and foster accountability and continuous learning.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior