Omrix Biopharmaceuticals is seeking a Quality Systems Manager for all sites.
Reports to: Quality Director
Location: the position is in the Omrix Nes-Tziona site.
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.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
•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 Omrix 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 Omrix sites.
•Oversees document control management process for all Omrix sites
•Oversees record retention management process for all Omrix sites
•Oversees document periodic review management process for all Omrix 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.
•Manages, leads and develops resources within the department.
•Involvement in Environmental, Health and Safety (EHS) aspects as required.
•Responsible for communicating business related issues or opportunities to next management level
•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
•Leads the Device, Labeling and Quality System Departments
•Responsible for all tasks and quality issues related to Devices: Production, Supply chain, QC and final release.
•Supervises the work of team members regarding Medical Device design control activities, complaints investigation, external interfaces with the device manufacturer and sterilization site.
•Oversees Annual Review of devices and its accessories, Device Master Records, Technical Files, 510(k)’s, process validation protocols and reports
•Oversees management of processes for Packaging and Labeling materials for all Omrix sites.
8-10 years of related experience and a University/Bachelor’s Degree is preferred.
Experience in the Medical Device industry or medical field
Demonstrated knowledge of manufacturing principles and practices, and procedures
Knowledge of quality systems business practices and software
Ability to work cooperatively with coworkers and
Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements
Excellent verbal and written communication skills,
Project management skills,
Process excellence tools/methodologies,
Preferred System analysis skills,
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
•Responsible for managing the following functions:
QA Analyst for labeling
QA systems analyst
Quality systems supervisor
Device Quality Engineer
•Facilitate and participate inn Management Review
•Manages the Quality Manual as well as the GMP guidelines update process and implement all standards that are cascaded down from enterprise level to ensure the compliance of Omrix with changing internal and external requirements.
•Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
•Manages the Site Management Review process and meeting and report the relevant KPIs.
•Deputy of person responsible regulatory compliance for medical device
•15% expected travel time for domestic & international projects.
•Supervise on-going follow-up & verification with external manufacturers activities in Israel and abroad.
•Supervise attendance in supplier review boards for external manufacturers and suppliers relating to Device and Labeling.
•Host regulatory audits and notified bodies audits and certification process.