Senior QA Specialist, Research & Early Development Quality

Corporate        ·        Oxford, United Kingdom          ·       Full time

• Multiple Locations:  Oxford, United Kingdom
•  Categories: Corporate
•  Req ID: 10556

Job Description

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.

To provide Quality Assurance oversight of the analytical study lifecycle during pre-clinical stages of the drug development life cycle.

Essential Functions

• To follow phase appropriate quality strategies for oversight across GxPs and non-GxP’s for non-clinical and pre-clinical studies such as Bioanalytical, DMPK, toxicology and pharmacology.
• Review study plans for completeness and clarity.
• Audit final reports and raw data from GLP studies.
• Review and approve SOPs relevant to research and early development stages.
• Review deviations/study amendments for impact to study.
• Ensure final reports are archived following approved procedures.
• Assist with selection and qualification of vendors for research and early development out-sourced activities.
• Follow procedures for material used in toxicology studies is appropriate for use.
• Collect and trend appropriate KPIs to measure vendor performance.
• Follow escalation procedures to resolve issues with vendors.
• Assist in audits of external vendors.
• Assist with ensuring appropriate CAPA’s are implemented following audits of external vendors.
• Attend operational meetings with CRO’s.
• Represent Research and Early development Quality on project teams and initiatives.
• Identify risks associated with non-clinical and preclinical studies and support remediation strategies.
• Assist in inspection readiness activities with research and early development teams.
• Assist in inspection readiness activities with CRO’s.
• To develop and initiate efforts designed to constantly improve and globally harmonise R&D CMC processes and systems.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participating in professional societies.
• Travels to locations as needed to facilitate/coordinate activities and resolve issues etc.

Required Knowledge, Skills, and Abilities

• Thorough understanding of the drug development lifecycle.
• Excellent organizational, verbal, communication and presentation skills.
• Ability to effectively participate on multi-disciplinary teams.
• Ability to work independently with minimal direction.
• Ability to work within a multi-functional environment.
• Ability to promote quality within an R&D environment.
• Proven collaborator in internal and external teams.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and pharmaceuticals.
• Ability to apply cGxP regulations and other FDA and international guidelines to all aspects of the position.
• Strong work ethic with a flexible and adaptable approach.

Required/Preferred Education and Licenses

• Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline.
• Significant experience working in pharmaceutical industry, including experience working within an R&D quality environment.
• Thorough understanding of Quality Systems and cGxP’s as applicable to non-clinical and clinical activities.
• Experience working with CRO’s.
• Quality Risk Management Experience essential.
   

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Please click here to apply.