Quality Systems Manager

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 Systems

Job Category

People Leader

All Job Posting Locations:

Kiryat-Ono, Tel Aviv District, Israel, Nes-Ziona, Center 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 a Quality Systems Manager position for our site in Ness Ziona.

Purpose

The Quality Systems Manager Manages the day-to-day operations of the Quality Systems staff. Oversees the development and implementation of processes, procedures, audits and corrective actions. Ensures effective communication and training are deployed throughout the business. Responsible for providing direction regarding the development and design of quality systems including processes, documentation and computer records.

This Role

• Ensures compliance of the Omrix Quality Management System with all applicable external cGMP regulations and internal GMP requirements
• Leverages knowledge from MD Quality Systems and J&J Quality & Compliance groups to implement J&J proven quality tools and programs in Omrix.
• Operates as a key business partner for quality and process improvement, understands business requirements and executes quality programs to drive organization capability building.
• Participates in Quality System initiatives to develop and deploy standardized systems across Surgery that meet company needs and advance capability.
• Ensures conformance with all applicable cGMP regulations within the department.
• Develops and drive improvement in the Quality System supporting the Omrix organization
• specifically, Management Review, Escalation, Trending, Quality Planning.
• Responsible for timely managing and effective closure of any assigned Deviations, CAPA’s and Change Control plans within the department.
• Reviews and approves NCs (non-conformances) and CAPAs (corrective and preventive actions), and SOPs as applicable
• Oversees change control management process for all Company sites.
• Oversees document control management process for all sites
• Oversees record retention management process for all sites
• Oversees document periodic review management process for all sites
• Overseas the alignment and implementation of external regulatory and internal J&J standards to Omrix procedures
• Facilitates and execute management review meetings
• Responsible for ensuring adequate training within the department.
• Oversees Trainings processes for all Omrix sites.
• Sponsorship of the Data Integrity Champions program.
• Responsible for communicating business related issues or opportunities to next management level
• Drive people leadership agenda, seeking for team growth and development and driving high performance teams based on our Credo and the Leadership imperatives values
• Deep understanding of HR employees' life cycle business processes and policies
• Act in compliance with Israel labor law regulation, J&J values and code of conduct
• Drive business operation excellence according to JJPS/JJOS methodology
• Budget management and Financial planning
• Strong JJSC business acumen to enable and advance business strategy execution
• 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
• Leads the Device, Labeling and Quality System Departments
• Oversees management of processes for Packaging and Labeling materials for all Omrix
• 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
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
  
  

• 8-10 years of related experience and a University/Bachelor’s Degree is preferred.
• Experience in the Medical Device/Pharmaceutical/Biologic industry or medical field
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• Knowledge of quality systems business practices and software
• Excellent verbal and written communication skills,
• Project management skills,
• Process excellence tools/methodologies,
• Presentation skills,
• People leadership,
• Talent development.
• Preferred System analysis skills,
• Engineering background
• Build strong cross functional partnership, interfaces and communication
• Lead in a matrix organization
• Establish a diverse and inclusive work environment and culture