Sr Quality Specialist, Manufacturing Quality Compliance
1 day ago
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.jazzpharma.com and follow @JazzPharma on Twitter.
The position is part of the Manufacturing Quality Compliance team serving the Business and Quality function. The role reports to the Head of Manufacturing Quality Compliance and is responsible for performing key Quality and Compliance tasks.
Essential Functions/Responsibilities
- Perform reviews of internal and external SOPs relevant to Manufacturing Compliance Quality; participate in the development and revision of SOPs for Quality stakeholders.
- Lead the generation of Quality Management Review (QMR) reports for review and presentation to senior management.
- Support the coordination and implementation of the Jazz Internal audit plan and Vendor audit plan for the GDP/GMP activities that include service providers, vendors, business partners, and internal audits.
- Support inspection readiness and inspection activities. May perform one or more inspection roles during an inspection (e.g., runner, scribe, QA checks, etc.).
- Perform auditing to support the Jazz Internal audit plan.
- Lead the maintenance of the inspection readiness toolkit, training materials for internal and external CMO cross functional teams.
- Lead the monitoring of trends in regulatory inspection activities (internally/externally), the Jazz Internal audit program and GMP regulatory changes.
- Support the management of GMP Regulatory Changes/Quality Intelligence assessments.
- Lead the management of the Quality and Technical Agreement (QTA) process and maintain the master list of QTAs.
- Support any initiatives regarding QTA standardization globally in Jazz.
- Contribute to the development of continuous quality process improvement.
- Work directly with other key Jazz Pharmaceuticals departments and Global GxP internal customers to ensure compliance and productive working relationships.
- Maintain current training in accordance with the Jazz Pharmaceuticals training curriculum.
- This position may require up to 10 to 20% travel.
Required Knowledge, Skills, and Abilities
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality systems, quality assurance, quality control and /or manufacturing areas.
- Excellent oral and written communication skills.
- Very experienced in data analysis and presentation.
- Experience presenting to Senior Management.
- Thorough understanding of quality systems and cGMP's.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Competency in using methods and tools to assist with Manufacturing Quality Compliance metrics.
- Ability to work in a team environment.
Required/Preferred Education and Licenses
- Bachelor's degree in chemistry, biology or a related discipline.
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: https://careers.jazzpharma.com/benefits.html.-
Dublin, Ireland Jazz Pharmaceuticals Full timeIf 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...
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