Senior Manager, Quality Systems

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

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

Job Category: People Leader

All Job Posting Locations: Anasco, Puerto Rico, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Senior Manager, Quality Systems to be located in Añasco, PR.

Purpose:

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.

Act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, enabling product quality, patient safety, and regulatory readiness.

Key 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.

Qualifications

Required:

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• A minimum of 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.

Preferred:

• 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; ability to influence without authority.
• Excellent written and verbal communication; able to present to senior leadership and cross-functional teams.
• Analytical thinker with strong problem-solving skills and attention to detail.
• Project and stakeholder management skills; able to prioritize and deliver results in a matrix environment.
• Commitment to building a culture of quality and compliance.
• Office and manufacturing floor presence required; PPE and site access per safety protocols.

Other:

• Travel: occasional to domestic sites/suppliers and regulatory inspections (as required).
• This role requires demonstrated integrity, adherence to compliance standards, and the ability to operate in a regulated environment.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

AI solution evaluation, Collaboration, Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Data Quality, Developing Others, Incident Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Team Management