If you are currently a Jazz Pharmaceuticals employee, please apply through our Internal Career site.

At Jazz Pharmaceuticals, we are a leading global biopharmaceutical organization committed to enhancing the lives of patients and their families through innovative therapies. We focus on developing life-altering medications targeting serious conditions, especially where few or no treatment options exist. Our diverse portfolio includes top therapies for sleep disorders, epilepsy, and an expanding range of cancer treatments. Driven by our dedication to patient outcomes, we pursue groundbreaking research and development in our extensive pipeline of therapeutics within oncology and neuroscience. Headquartered in Dublin, Ireland, we operate research and development labs, manufacturing sites, and a dedicated workforce across multiple countries, united in our mission to support patients globally. For further details about our company, please visit our website.

Overview of Responsibilities:

This position is an integral part of our Manufacturing Quality Compliance team within the Business and Quality function. Reporting to the Head of Manufacturing Quality Compliance, you will undertake essential Quality and Compliance assignments that are central to our operations.

Key Responsibilities

• Conduct thorough reviews of internal and external Standard Operating Procedures (SOPs) pertinent to Manufacturing Compliance Quality; actively engage in developing and updating SOPs for Quality stakeholders.

• Lead the creation of Quality Management Review (QMR) reports for presentation and examination by senior leadership.

• Assist in the coordination and execution of the Jazz Internal audit plan and Vendor audit plan related to Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP), encompassing service providers, vendors, business partners, and internal audits.

• Facilitate inspection readiness and engage in inspection activities, potentially filling various roles during inspections (e.g., runner, scribe, QA checks).

• Conduct audits that align with the Jazz Internal audit plan.

• Spearhead the upkeep of the inspection readiness toolkit as well as training materials for internal and external Cross-Functional Management Organizations (CMOs).

• Track trends in regulatory inspections (both internal and external), the Jazz Internal audit program, and modifications in GMP regulations.

• Support the oversight of GMP Regulatory Changes and Quality Intelligence assessments.

• Manage the Quality and Technical Agreement (QTA) process and maintain a comprehensive master list of QTAs.

• Assist with initiatives focused on global QTA standardization within Jazz.

• Contribute to the continuous improvement of quality processes.

• Collaborate effectively with key departments across Jazz Pharmaceuticals and Global GxP internal customers to ensure compliance while fostering productive working relationships.

• Stay updated with training requirements in accordance with the Jazz Pharmaceuticals curriculum.

• This role may necessitate travel of up to 10 to 20%.

Qualifications

• A minimum of 3-4 years of experience in pharmaceutical/biologics finished product quality assurance, quality control, and/or manufacturing.

• Exceptional oral and written communication abilities.

• Extensive experience in data analysis and presentation.

• Proven track record of presenting to senior management.

• Deep understanding of quality systems and current Good Manufacturing Practices (cGMP).

• Strong interpersonal skills to interact effectively with individuals at all organizational levels, including senior executives, contractors, and colleagues.

• Familiarity with tools and methodologies that assist in Manufacturing Quality Compliance metrics.

• A collaborative team player.

Education and Licenses

• A Bachelor’s degree in chemistry, biology, or a related field is required.

Jazz Pharmaceuticals is proud to be an equal opportunity/affirmative action employer. We promote a diverse workforce and welcome applications from qualified candidates regardless of race, color, religion, sex, national origin, disability status, veteran status, or any other characteristic protected by law.

The selected candidate will enjoy a range of competitive benefits, including medical, dental, and vision insurance, a retirement savings plan, and flexible paid vacation. For more information about our benefits package, please click here.

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