Senior QA Specialist, Pharmaceutical Development Quality Assurance (Maternity Leave Cover - Remote / Home Based)

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

Jazz Pharmaceuticals is a global biopharma 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, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit

for more information.

Job Description:

This position is part of the PDQA group with the Drug Discovery and Pharmaceutical Development Quality team at Jazz Pharmaceuticals. The position supports the Pharmaceutical Development and Manufacturing Sciences Team (PDMS) in contract manufacturing operations and development of Investigational Medicinal Products (IMPs) and ensures that suitable IMP is provided to the Clinical Trials Supply Management (CTSM) Team for use in clinical trials.

Responsibilities:

The individual is responsible for but not limited to:

Represent PDQA on CMC matrix teams for Jazz development Projects

Monitor the operations at the Contract Manufacturer of IMPs, perform batch review, review product complaints, deviations, change controls and product related investigations (OOS investigations, deviations and CAPAs).

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.

Managing the product stability programme for IMPs

Develop and write SOPs & controlled documents as required.

Generate and maintain Product Specification Files (PSFs)

Review and approval of product labelling

Build authentic relationships and participate in meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s), QP Agreements and QP Declarations.

Operating supplier management process to include qualification, re-qualification and discontinuation of contractors.

Participate in continuous improvement projects utilising Operational Excellence programs.

Developing and maintaining Quality Systems and ensuring that all operations are fully in compliance with current international standards for cGMP.

Support validation activities.

Supporting CTSM with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.

Other Responsibilities:

Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.

Work closely with other members of Technical Operations organization to ensure delivery of key project objectives and timelines

Contribute to management of the supplier approval program through audit participation and GxP compliance oversight

Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.

Maintain appropriate Quality Technical Agreements with all GxP vendors

Supporting regulatory submissions

Personal Competencies:

Bachelor's degree in chemistry, biology or a related discipline

Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas

Experience with third party vendor auditing, complaint handling and change control

Thorough understanding of quality systems and GMP/GDP

Very good oral and written communication skills

Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues

Experience working with contract manufacturing

Experience interfacing with regulatory bodies or supporting regulatory submissions

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here