Director, In-Market & Affiliate Quality, Europe (Remote)

  • Jazz Pharmaceuticals
  • Oxford, UK
  • Jun 11, 2024
Permanent

Job Description

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter.

The EU, UK and EEA regions are key areas for commercial supply and growth. This role oversees Quality for the Jazz affiliate offices and supply across these geographies. The purpose of this role is to lead the Affiliate Quality strategy and ensure compliance for the distribution and supply of medicinal products into these markets. The role includes be leadership and development of the EU In-Market Quality team, and regular communications with regional commercial teams, country general managers and other key stakeholders in each of the locations.

Key responsibilities include:

  • To oversee and ensure consistent and compliant quality systems across EU, EEA and UK Markets
  • Lead the Quality team in this region and nuture a high performance culture
  • Develop strong partnerships with senior leadership and commercial marketing teams
  • Facilitate successful implementation of the Jazz Quality roadmap
  • Identify and mitigate potential quality risks in the supply chain
  • Drive meaningful quality resolutions
  • Interact with health authorities to communicate a consistent quality-driven approach for Jazz products

This role reports to the Senior Director, In- Market & Affiliate Quality.

Essential Functions

  • Lead Quality team operations for the distribution of commercial products in EU/EEA/UK region
  • Nurture positive and collaborative relationships with key stakeholders
  • Drive continual improvement and operational excellence
  • Influence senior leadership in support of the In-Market Affiliate Quality intent and strategy
  • Establish and monitor appropriate Key Performance Indicators
  • Support new submissions and managed access programs
  • Ensure preparedness for local inspections
  • Drive corrective/preventive actions for identified compliance vulnerabilities
  • Support the wider In-Market Quality teams.
  • Responsible for ensuring products remain distributed in accordance with respective licenses and within applicable Jazz global and local regulatory requirements
  • Facilitate Brand Protection investigations for potentially Falsified Medicines
  • Operate in accordance with Jazz values of Integrity, Collaboration, Passion, Innovation and the Pursuit of Excellence

Required Knowledge, Skills, and Abilities

  • Deep knowledge of pharmaceutical quality/supply operations, especially for Affiliate Offices
  • Previous experience or demonstrated detailed understanding of QP/RP responsibilities
  • Ability to build local requirements into a global quality system
  • Cross functional working
  • Risk Management
  • Flexibility
  • Conflict management
  • Problem solving
  • Excellent command of English; fluency other European languages an advantage

Required/Preferred Education and Licenses

  • Bachelor Degree or equivalent
  • RP and/or QP eligibility preferred

Description of Physical Demands

  • Constantly operating a computer, printer, telephone and other similar office machinery
  • 20-30% travel will be required

Jazz Pharmaceuticals is an Equal Opportunity Employer.