Director, Pharmaceutical Development QA

If you are a current 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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Job Description

Brief Description:

As a Director in the PDQA team you provide leadership to the PDQA QP Team and actively contribute to the quality oversight of the Jazz product development pipeline through clinical phases from a science-led, risk based and patient centric approach.

This position is responsible for the management of the day-to-day quality activities relating to pharmaceutical development and providing technical support in relation to issues that can arise with Jazz development products, contract manufacturing organizations and material suppliers, to all applicable GxP standards.  This role also includes cross-functional team membership/collaboration and support for quality aspects of CMC regulatory dossiers.

The position reports to the Head of Drug Discovery and Pharmaceutical Development Quality. 

Essential Functions

• Act as a Qualified Person (QP) named on the Jazz Dublin MIA IMP.
• Lead the PDQA QP Team at Jazz Pharmaceuticals.
• Act as a PDQA representative on CMC product teams for assigned development projects.
• Ensure that the PDQA QP team provides appropriate support to the CMC matrix teams within Jazz Pharmaceuticals, ensuring that Phase Appropriate GMP is followed throughout the drug development process.
• Provide ‘Quality’ advice on technical issues that may arise for both small or large molecule development projects.
• Ensure the implementation of appropriate global Quality oversight, through Phase I - IV clinical phases of pharmaceutical development.
• Develop and initiate efforts designed to constantly improve and harmonize global processes and systems within PDQA.
• Work closely with the Clinical Trial Management Supply Team to ensure supply of clinical trial material to clinical development programmes.
• Interpret, communicate and implement changes in GMP, ICH and compliance related regulations, standards and practices, as related to pharmaceutical development.
• Promote a product understanding and risk-based approach to Pharmaceutical Development activities, ensuring that Quality Risk Assessments are performed and documented, identifying appropriate Critical Quality Attributes and Critical Process Parameters.
• Provide information and attend, when required, key meetings, such as Quality Management Review, Specifications committee, Pharmaceutical Development Review Committee and the Supplier Review Board, in the context of pharmaceutical development.
• Provide Quality review of CMC regulatory submissions, when required.
• Contribute and provide SME quality support for the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required.
• Act as lead auditor in third party vendor audits for IMPs, to include: GMP contract manufacturing, analytical testing and storage facilities when required to ensure compliance with Jazz requirements and country specific regulations.
• Ensure compliance of all contract manufacturers to both internal Jazz requirements and country specific regulations.  To include person-in-plant support, when required.
• Prepare and/or act as an SME for Quality Technical Agreements within the PDQA Team
• Facilitate Technology Transfer, process scale-up and process improvement projects i.e. assisting with the transitioning of Jazz development products from the Investigational Medicinal Product space to Commercial Product space.
• Work closely with other members of the Technical Operations group to ensure delivery of key project objectives and timelines.
• Responsible for the successful, timely completion of goals and objectives within PDQA.

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