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生產, 美國 | 2021-06-22

GDP 質量運營副總監/總監

Job Title: Associate Director/Director, GDP Quality Operations Job Category: Exempt/Non-Exempt
Department/Group: Quality Assurance Travel Required: Yes, 25%
Location: Florham Park, NJ Position Type: Full Time
Level/Salary Range: Mid-Level Hiring Manager VP, Quality Assurance

Primary Functions

  • The Associate Director/Director, GDP Quality Operations will apply expert knowledge of Good Distribution Practice (GDP) in delivering quality assurance in the Development and Commercial supply chains.
  • The position will apply expert Good Manufacturing Practice (GMP) knowledge (US and EU) to support HUTCHMED Group GMP QA in the management of product quality internally and at Contract Manufacturing Organizations (CMO).
  • The position will support other GxP Quality Operations of HUTCHMED Group, as required, promoting a quality culture throughout the organization.

Major Responsibilities and Duties

  • Perform oversight of third-party logistics (3PL) companies’ and specialty distributors’ quality management systems; facilities, equipment, vehicles; processes and documents; repackaging/relabeling; complaint handling; recall management; returns management; counterfeit handling; importation; sub-contracting; and self-inspection to ensure compliance with internal policies, procedures, regulatory requirements, and best industry practices.
  • Fulfills Quality role as defined within the Quality Policy and Quality Management System.
  • Support GDP/GMP compliance; issue management, deviation investigations, change controls, and CAPA; and inspection readiness based on strong technical expertise in global regulatory requirements.
  • Plan and lead audits internally, at CMOs, 3PL and specialty distributors ensuring CAPA implementation and effectiveness.
  • Implement and oversee Quality Agreements.
  • Manage and respond to regulatory inspections.
  • Participate in continuous process improvement projects.
  • Participate in SOP development and periodic review.
  • Provide quality training and communicate best practices and lessons learned.
  • Acts as a strong technical resource and is called upon to resolve GDP/GMP issues based on knowledge of relevant SOPs (Standard Operating Procedures), GDP, GMP regulations and guidelines as well as local regulations.
  • Oversee EU QP activities and communications.
  • Support CMC colleagues through consultation to aid in their decision-making.

Qualifications and Education Requirements

  • Bachelor degree (required) or higher in scientific, medical or related discipline.
  • 8+ years of experience in the pharmaceutical industry, including 5+ years in GDP Quality.
  • Deep knowledge global regulations and guidelines (e.g. EU Directives, US FDA, PMDA, ICH, and National regulations).
  • Strong background in managing CMO and 3PL in the US and EU.
  • Demonstrated critical thinking and problem-solving in the application of global regulations.
  • Inspection management experience (FDA, EMA and other inspectorates).
  • Demonstrated leadership with proactive, collaborative support to cross-functional peers. A team player with strong influencing and negotiation skills.
  • Ability to plan and organize work in an efficient manner.
  • Ability occasionally to work outside of business hours in home time zone to accommodate global team time zones.
  • Flexibility to respond to changing business needs.
  • Experience using data analytics tools and systems preferred.
  • Strong verbal and written communication.
  • Ability to travel up to 25%.