Site Quality Director

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Vision

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

Are you passionate about improving and expanding on the possibilities of vision treatments Ready to join a team thats reimagining how vision is improved Our Vision team solves the toughest health challenges. Help combine cutting-edge insights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Site Quality Director to be located in Añasco PR.

The Site Quality Director leads the Johnson and Johnson Surgery Vision Quality Operations organization ensuring compliance with quality requirements continuous supply to customers compliance and regulatory agencies requirements among others. Responsible for taking a leadership role in defining short and long-term strategies for the facility.

Has accountability through direct reports over inspection and release of incoming raw materials in-process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations Make Engineering Production Planning and Logistics and Product management to assure a horizontal approach to resources management and prioritization.

Key Responsibilities:

• Serves as local Quality Systems Management Representative for the site.

• Operates tactically within the operations environment to ensure practical and timely provision of Quality decision making.

• Oversees management of the day-to-day quality activities.

• Makes decisions on non-conforming material as required by the Quality System procedures.

• Evaluates and communicates quality events for elevation to Risk Management Board and/or Quality Board as per applicable procedures.

• Develops the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA functions to optimize the performance of operations compliance and quality systems as well as influence the global integration and alignment of goals across the organization.

• Serves as Host for 3rd party audits; participates and presents in Quality and Compliance Executive Reviews Management Reviews Quality Boards and others as requested/required.

• Reports to Executive Management on the effectiveness of the Quality Management System and any need for improvement.

• Ensure the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements throughout the organization.

• Ensures that processes needed for the Quality Management System are documented.

• Evaluates the site Quality Operations capabilities identifies gaps and recommends issue resolution to Executive Management. Develops and leads innovative initiatives to improve business performance to support visionary changes.

• Provides coaching and staff development manage performance succession planning and departmental budget. Is accountable for organizational capabilities to meet current and future business needs.

• Serves as a technical expert for functional areas with conceptual knowledge of all quality functions and business areas.

• Serves as Subject Matter Expert (SME) for execution of Quality Systems in the site during inspection readiness activities. Supports the preparation of any communications with FDA related to any follow-ups of inspections carried out at the site.

• Directly supports the design and deployment of Quality Systems improvements standards and policies at site level.

• Observes all Companys Environmental Safety and Industrial Hygiene policies and regulations.

Qualifications

Education:

• Bachelors degree in a Life Science Engineering Physical Science or equivalent is required.

Experience and Skills

• A minimum of 10 years of experience in the Medical Devices or Pharmaceutical sector with 5 years of experience in Quality is required.

• Previous people management experience is required.

• Regulatory experience including US Class III (PMA) and US Class II regulations supporting timely and compliant regulatory submissions inspections and audits is required.

• Demonstrated knowledge of ISOCFR Part 820 EU MDD/MDR and MDSAP is required.

• Demonstrated knowledge of manufacturing/quality principles and practices is required.

• Front-room role experience with FDA (or similar) and Notified Body inspections is required.

• Multi-functional experience (Quality Planning Operations Engineering etc.) is preferred.

• Strong verbal and written communication to all levels of the organization influencing and leadership skills are required.

• Strong project management and problem-solving skills are required.

• Ability to influence at senior levels and across functions building strong networks internally and externally. Experience delivering results through influence in a highly matrix environment.

• Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas is required.

• Ability to build strategic partnerships to accomplish company goals in a team environment is required.

• Ability to handle multiple projects simultaneously and the judgement to discern and resolve major quality issues is required.

• Ability to work in stressful/fast paced environment is required.

• Ability to write and speak in English and Spanish is required.

• Domestic or international travel at 10% as required.

• This position requires to work onsite at the Johnson & Johnson Vision site located in Añasco PR.

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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Preferred Skills: