Site Quality Lead

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

Multi-Family Quality

Job Category

People Leader

All Job Posting Locations:

IL003 Kiryat Ono, IL005 Jerusalem, IL007 Nes-Ziona, IL008 ACT Tel Aviv, Israel, Jerusalem, Center District, Israel, Kiryat-Ono, Tel Aviv District, Israel

Job Description

About Surgery

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

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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 Our Site Quality lead for our Ness Zionna site in Israel.

In this role, you will: Serve as Management Representative for the plant. Lead the Quality System execution at the plant. Plan, execute and manage quality assurance systems and activities including quality engineering, product release, corrective and preventive action and non-conforming system, complaint investigation, document control and training systems, ensuring compliance with regulatory and company requirements.

Serve as Management Representative for the OMRIX Biosurgery and Medical Device manufacturing plants ensuring appropriate staffing, skills and competencies are consistent with present and future needs. Plan, execute, and manage quality assurance systems and activities including quality engineering, product release, corrective and preventive action and non-conforming system, complaint investigation, document control and training systems, ensuring compliance with regulatory and company requirements. Serves as the head of Pharmacovigilance including compliant execution of the Omrix Pharmacovigilance quality system and applicable international regulations.

SECTION 2: DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Assure establishment, implementation, and execution of the quality system at the plants and utilize process excellence tools/ methodology for continuous improvement and predictability.
• Maintain plants in compliance with applicable regional and global Quality System laws, regulations and standards including corporate regulatory, human resource programs, policies and procedures, and safety/environmental and occupational health systems.
• Ensure that the facilities remain continually certified to applicable licenses
• Serve as Management Representative per ISO13485 & FDA QSR.
• Maintains a thorough understanding of applicable pharmaceutical and medical device quality system regulations & standards related and promote awareness of such requirements throughout the manufacturing sites for products manufactured.
• Report to top management on the performance of the quality management system, its compliance towards requirements and opportunities for improvement. Communicate business related issues or opportunities to next management level.
• Coordinate compliance efforts within the facilities.
• Ensure that the Quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
• Support Quality Improvement Processes and all activities to achieve World Class Manufacturing plant.
• Maintain an effective Quality Information System (Document Management, Nonconformances, etc).
• Ensure that facility associates are educated in regulatory requirements.
• Maintain systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Has the authority to stop production/shipments if quality requirements have not been met.
• Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
• Participate in or support major plant projects, such as transfer of new product or processes.
• Ensure plants have appropriate resources with appropriate competencies to execute the Quality System.
• Scope of operation encompasses approximately 100 direct and extended reporting personnel on multi shift schedules. Direct subordinates typically are Quality Operations Managers, Quality Control Managers, Quality Systems Manager, and CAPA / NCR Lead. Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that resources needed to do so are available and in good condition.
• Recruit, select and develop adequate human resources. Evaluate and recommend staffing requirements to insure maximum utilization of personnel to fulfill department objectives.
• Establish, and operate within an effective budget and manpower plan for the QA & QC organization.
• Approve salary increase recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conduct performance reviews and provides guidance to subordinates.
• Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.
• Takes appropriate actions to create and maintain a working environment aligned with OUR CREDO.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable 
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
  
  

• B.Sc degree in Business, Life Science, Physical Science, Engineering or other related field required.
• Minimum of 5-10 years of experience in compliance or quality in a regulated (FDA) environment.
• Five (5) years in supervisory skills, preferably QA Exempt personnel
• Experience in biopharmaceutical manufacturing is required, experience with combination products is preferred.
• Experience in handling patient/customer complaints, inquiries or servicing issues preferred
• Experience interacting with FDA, EMA and other regulatory agencies preferred
• Leadership and management skills.
• Experience or proven record motivating leading and developing staff, in a highly changing environment.
• Excellent communication and interpersonal relation skills.
• Regulatory compliance knowledge and skills including advanced Quality Systems knowledge.
• Interpretation and application of QSR and ISO Standards
• Statistical and analytical problem solving, Six Sigma, Quality Engineer or Quality Auditor Certifications are preferred
• Demonstrating fortitude to make Quality calls.
• Working through multiple set-backs and unforeseen challenges.
• Language Skills: English mandatory for all plants, Hebrew strongly preferred
• Member of site leadership team
  
  

• The position is primarily located in Israel.
• Up to 20% of expected travel for domestic and/or international is required
• The position requires interactions with regulatory agencies, and third-party suppliers