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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 https://www.jnj.com

Job Function:

Quality

Job Sub** **Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Director, Quality Control to be located in Gurabo, PR.

The Director of Quality Control is a key member of the site leadership team, responsible for leading all aspects of all laboratory operations and ensuring compliance with cGMP, regulatory standards, and company policies. This role sets the strategic direction for the QC department, aligning medium- and long-term goals with site and global Quality objectives. The QC Director cultivates a culture of excellence, innovation, and continuous improvement while ensuring timely and accurate testing to support product quality and patient safety.

Key Responsibilities

+ Lead all QC laboratory operations, including chemical, microbiological, and physical testing of raw materials, packaging, in-process, final product, and stability samples.

+ Ensure full compliance with EHS and GxP standards, regulatory requirements, and internal procedures.

+ Develop and implement strategic plans to support technology transfers, product launches, and continuous improvement initiatives.

+ Serve as a key contributor to site and regional leadership teams, representing QC in cross-functional and global forums. Works collaboratively with peer Lab Leaders in the QC Platform to lead and supply to local, regional, and global projects that drive value and continuous improvement within the J&J Supply Chain.

+ Drive performance metrics such as on-time testing, right-first-time results, and operational efficiency .

+ Ensure timely closure of investigations, CAPAs, and change controls related to laboratory operations.

+ Maintain GMP-compliant laboratory facilities, equipment qualification, calibration, and cleanliness and provides direct support to internal audits, regulatory inspections, and Escalation meetings for QC-related issues.

+ Conduct quality risk assessments and support resolution of customer complaints.

+ Build and lead a high-performing QC team, including Managers and Supervisors.

+ Make hiring decisions, ensure appropriate staffing levels, and provide adequate training and development.

+ Ensure that all personnel assigned to the QC department have the necessary education, training, and experience to fulfill their job duties and responsibilities.

+ Provide coaching, mentoring, and performance management aligned with J&J Leadership Imperatives: Connect, Shape, Grow.

+ Develop a clear talent strategy for technical and leadership growth within the QC function.

+ Coordinate budgeting, resource planning, and cost forecasting for operational and capital expenditures.

+ Approve high-value purchases and ensure alignment with company financial controls.

+ Review and approve QC data, protocols, procedures, and technical reports.

+ Provide expert guidance on laboratory operations, regulatory compliance, and data integrity.

+ Support global QC initiatives and collaborate with peer lab leaders across the J&J Supply Chain.

+ Implement innovative technologies and process improvements to reduce testing cycle times and enhance lab productivity.

Qualifications

Education

+ Bachelor’s degree experience in Life Sciences, Engineering, or a related field required.

+ Advanced degree (M.Sc., Ph.D., MBA) preferred.

Experience and Skills

+ A minimum of 10 years of dynamic experience in QC laboratory management within a GMP-regulated environment.

+ Proven track record in leading Health Authority inspections (FDA, EMA, etc.).

+ Experience in international and virtual environments, including strategic project delivery and budgeting.

+ Maintains a safe work environment in compliance with all applicable Enviromental, Health and Safety (EHS) standards and regulations.

+ Demonstrates required skills for the roles including but not limited to: critical thinking and leadership, quality systems and regulatory expertise, risk management and audit readiness, talent development and team leadership, budgeting and resource optimization and Data integrity, LIMS/ELN systems, and technical writing.

Others:

+ Certifications of cGMP/GLP and other regulatory training required

+ Lean Six Sigma or Process Excellence certification preferred.

+ Fully bilingual in English and Spanish (verbal and written) preferred

+ Proficient in Microsoft Office and statistical/data analysis software

+ Strong interpersonal, negotiation, and communication skills.

+ This position may require up to a 10% of domestic and/or international travel.

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.

\#LI-Onsite

Required Skills:

Preferred Skills:

Compliance Management, Consulting, Developing Others, Human-Computer Relationships, Inclusive Leadership, Industry Analysis, Leadership, Operational Excellence, Performance Measurement, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Resource Management, Standard Operating Procedure (SOP)