About Us
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate and 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.
Our Approach
We have a patient-focused and science-driven approach that powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Our diverse portfolio of marketed medicines includes leading therapies for sleep disorders and epilepsy, as well as a growing portfolio of cancer treatments.
Our Team
We are headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities, and employees in multiple countries committed to serving patients worldwide.
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The Role
Job Summary
The Biologics Drug Substance Quality Assurance Specialist will be responsible for performing key quality tasks in respect of Company products. The role will work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems.
Essential Functions/Responsibilities
* Monitor and support the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards.
* Perform batch review and disposition, review and approve product complaints, deviations, validation protocols, change controls, and lead product-related investigations.
* Ensure compliance of all respective contract manufacturers to both internal Jazz requirements and country-specific regulations.
* Collaborate with contract manufacturers, packagers, and testing laboratories to resolve any quality issues.
* Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required.
* Highlight any risks associated with maintaining supply of commercial drug products to all markets.
* Conduct vendor audits and vendor site visits as required.
* Assist in internal audits and regulatory agency inspections.
* Summarize CMO Annual Product Quality Reviews and support regulatory submissions.
* Assist with the generation of Jazz APQR (Annual Product Quality Review).
* Maintain product-related Quality Technical Agreements (QTAs).
* Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations as appropriate.
* Review and approve moderated complexity deviations and associated corrective actions.
* Review and approve less complex validation documents.
Required Knowledge, Skills, and Abilities
* Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/Biotechnology Industry.
* Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of biologics drug substance manufacturing.
* Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.
* Experience with contract manufacturing is desirable.
* Significant experience (>5 years) of commercial and/or late-state clinical phase GMP manufacturing of biologics drug substance products.
* Highly organized, with exceptional time management and prioritization.
* Excellent verbal and written communication skills.
Required/Preferred Education and Licenses
* Bachelor's degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology, or a related discipline.
What We Offer
The successful candidate will also be eligible to participate in various benefits offerings, including medical, dental, and vision insurance, retirement savings plan, and flexible paid vacation.