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Quality Risk Management and Continual Improvement Manager

Quality Risk Management and Continual Improvement Manager

Manpower SwitzerlandCadempino
5 days ago
Job description

Founded in 1948 in Milwaukee, Wisconsin, USA, Manpower is a leading international human resources company. Located in 75 countries worldwide, with over 3’000 branches, Manpower responds to the needs of its 400’000 customers.

Specialists in the recruitment and selection of permanent and temporary personnel in various economic sectors, we have been existing in Switzerland for over 60 years with more than 300 employees in more than 40 branches.

For an important company, we are looking for the following profile :   Quality Risk Management and Continual Improvement

Main Responsibilities :

Complaints Handling

  • Oversee complaint management, process improvements, metric tracking, and risk mitigation.
  • Record and follow complaints for products in EU, ROW, including LATAM (excluding France, US, and Canada).
  • Maintain the TrackWise Database and coordinate with Group Entities, Affiliates, and Third Parties.
  • Interface with internal and external stakeholders for complaints handling.
  • Monitor and trend complaints worldwide.
  • Support Corporate Drug Safety in reconciliation and PSUR issuing.
  • Act as Subject Matter Expert during inspections and audits.
  • Escalate issues related to complaint trends and nonconforming products.

Audit Management

  • Support data collection for entities and vendors to consolidate the Risk Model.
  • Issue the Risk-based Global Audit Program under supervision.
  • Conduct assigned GxP audits and monitor audit status through CAPA Plans.
  • Coordinate with third-party auditor firms.

    • Alert Management

  • Coordinate and follow up on Alert records.

    • Global Response Team Handling

  • Support GAP Assessments and Global CAPAs until closure under supervision.

    • Quality Risk Management

  • Ensure periodic updates of risk for entities and Global Vendors for effective audit programming.

    • Vendor Quality Management

  • Manage quality compliance for Global GxP Vendors and maintain the repository.

    • Other Tasks

  • Identify and implement Continuous Improvement opportunities.
  • Report and resolve significant Quality issues.
  • Work with stakeholders on CAPA reviews and maintain CAPA compliance.
  • Ensure good documentation practices and data integrity.
  • Issue and revise procedures and quality guidelines as per plan.

    • Education

  • Master’s degree in Life Sciences (e.g., pharmacy, chemistry, engineering, biotechnology, medical device) or related fields.

    • Professional Experience and Skills

  • Experience of 4-8 years in Quality Assurance / Control
  • Experience in auditing, certification is a plus
  • Cross-functional and global team experience.
  • Knowledge of product regulatory requirements and EMA / FDA regulations.
  • Ability to interpret policies, standards, and regulations.
  • Knowledge of quality systems, CAPA system, and compliance assessments.

    • Professional Knowledge

  • Understanding of GxP, ISO 13485, ISO 9001.
  • Business mindset with strategic thinking.
  • Project management skills.
  • Fluent in English; knowledge of Italian or French is a plus.

    • PLEASE REGISTER YOURSELF AND UPLOAD YOUR CV AT OUR OFFICIAL WEBSITE : WWW.MANPOWER.CH , IN ORDER TO PROCESS YOUR APPLICATION.