Senior QA Specialist (Remote/Home Based)

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.

The Quality Systems Team have an exciting opportunity within the QMS Global Process Owner (GPO) Team. We are looking for a passionate, driven individual who has excellent communication and change management skills, attention to detail and an awareness of Pharmaceutical regulations. This role will be primarily managing Marketing Authorisation Holder (MAH) & license update reporting, Product Complaint oversight and identifying and leading improvement opportunities to ensure our processes are fit for purpose and continually improving.

As part of the GPO team the role will also include opportunities to perform the GPO role for other elements of the QMS. The Quality Systems Group provide global stewardship and ownership of key elements of QMS, LMS and QA Digital responsibilities. The role will report to the Quality Systems Process Manager and be responsible for performing key Quality tasks including ownership of assigned QMS processes and support of the Quality Management System (QMS) itself via the generation of metrics and presentations for senior management.

The position is responsible for developing and maintaining aspects of the Quality Systems and to ensure that all operations are fully in compliance with current international standards for GxP. The individual is responsible for, but is not limited to, the following:

• Act as Global Process Owner and provide oversight for assigned processes within the QMS.
• Processes currently owned and supported by the QMS team include Change Controls, Extension Requests, Effectiveness Checks, Deviations/CAPAs, Product Complaints, Document Management, Vendor Certification, Audit and MAH & license update communications.
• Leading Cross-Functional Teams to enhance performance and compliance to global QMS processes.
• Implement enhancement initiatives through engaging with Global Stakeholders and aligning objectives with Global Departments & Functions.
• Assess the effectiveness and efficiency of Quality System processes and support the voice of Global Customers by implementing improvements and reporting on Key Performance Indicators (KPIs).
• Proactively look for continuous improvement opportunities within the QMS.
• Develop and present Quality Systems Technical Training to Global users as required.
• Be a key member of the company audit support team during regulatory or customer audits.
• Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.

Broad experience working in finished product pharmaceutical / biologics, including in depth knowledge of quality assurance as applied across GxP’s. Very good oral and written communication skills. Competent in the use of Microsoft Office applications like Word, Excel, PowerPoint, TEAMS, SharePoint and Outlook. Very experienced in data analysis, data presentation, and change management. Thorough understanding of quality systems and cGMP's. Interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues.

Competency in using methods and tools to assist Quality Systems metrics including the use of AI. Understanding of MAH responsibilities. Bachelor's degree (or equivalent) in chemistry, biology or a related discipline. Preferred experience with Veeva Quality Suite.

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.