Hologic Supply Chain Quality Assurance Manager in Belgium

Supply Chain Quality Assurance Manager

Post Date Sep 24, 2018

JOB SUMMARY

Responsible for providingleadership and technical support to assure quality compliance related to all supply chain activities within EMEA.

This function deliversthe implementation of quality to ensure capability for operations and distribution.This will be applied throughassuring Compliance with international and corporate supplier management processes and any other applicable regulatory requirements.

This role oversees, provides guidance and take ownership for the application of supply chain QA practices and techniques to specific situations,to ensure new suppliers, distributors and warehouses are chosen based upon assessment for business requirements and to ensure all quality activities and communication with the suppliers are completed including but not limited to validation, product verification, audit and any other required activities deemed neededto ensure the continuing suitability, adequacy and effectiveness of Hologic’s Quality System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Provides leadership, technical support and ownership to all aspects of supply chain quality in EMEA to address product related quality issues through daily interactions

  • Implement all GDP (Good Distribution Practices) to all supply chain of all Hologic and third party products within EMEA.

  • Communicates current and applicable regulations applicable for the supply of Hologic products and services

  • Leads team to create documentation associated with quality supply chain activities including but not limited to :supplier agreements, supplier files , and supplier assessments/audits.

  • Ensures and owns execution of activities to support change control activities and document management requirements by collaborating with applicable departments and peers to define requirements for individual projects

  • Responsible for technical investigations plans, reports and related procedures which ensure validity, adequacy and compliance to regulatory and corporate requirements

  • Attend and lead regular communication meetings with cross-functional teams to identify the root cause of problem and create remedial plans for short-term and long-term resolutions

  • Provide leadership in the preparation of risk assessments using tools such as Failure Mode and Effects Analysis (FMEA)

  • Supports the delivery of system solutions by assuring activities are conducted in a compliant but cost effective manner. Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations

  • Develop and manage supply chain quality KPI’s for thecorporate metrics

  • Participate in the EMEA Management Reviews

  • Perform other related duties as assigned

EDUCATION AND EXPERIENCE

  • BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through experience in supply chain quality environment in the medical device or pharmaceutical industries

  • Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements (9001 / 13485)

  • Must have advanced knowledge of supplier quality requirements and extensive knowledge in GDP

  • Proficient in spreadsheets and word processor applications

  • Proficient in concepts of statistics, sampling plans and statistical analysis

  • Ability to independently plan, execute, and/or problem solve moderate to complex situations

  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

  • Must demonstrate leadership attributes

  • Solid oral and written communication skills

  • Ability to manage multiple projects

  • Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation

  • Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively

PHYSICAL DEMANDS

  • Flexible working hours and travel is required for business requirements

ACCOUNTABILITY

  • Responsible for ensuring that related supplier quality activities comply with current regulations

  • Team achieves site and company goals and objectives