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.

This position reports into the Head of Manufacturing Quality Compliance. The Senior Manager, Audits and Inspections is a significant contributor to the Internal... Audit Program (GMP / GDP) and provides compliance support for GMP/GDP inspection management/readiness and for ensuring periodic inspection/audit readiness checks on internal sites/Contract Manufacturing Organisations areas are performed.

The Senior Manager, Audits & Inspections is responsible for managing activities to regularly verify that Jazz system Vendors, commercial partners and Jazz Global Quality and other teams are operating in line with applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System.

In addition, the Senior Manager, Audits & Inspections will support, identify and communicate compliance risks and be involved in monitoring trends in regulatory inspection activities (internally/externally) to proactively identify potential areas of risk and oversee action plans to mitigate risks (if applicable).

This person will act as deputy for the Head of Manufacturing Quality and Compliance representing Manufacturing Quality Compliance and at times may be asked to perform activities to support other GxP areas.

Essential Functions
• Maintain professional expertise and knowledge of local and international regulations relative to GMP/GDP and Quality.
• Manage and contribute to the execution of the Jazz Internal audit program (GMP/GDP), and implementation of the plan.
• Perform reviews on internal and external SOPs; participate in the development of SOPs for Quality stakeholders.
• Manage and implement the deployment of the strategic audit plans for GDP/GMP activities that include service providers, vendors, business partner, and internal audits.
• Lead auditor or co-auditor for GMP/GDP audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) ensuring compliance with Jazz requirements and country specific regulations.
• Present QA findings/observations to Jazz senior management and if appropriate, to the responsible service provider, vendor, or partner company.
• Perform the evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
• Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g., scribe, backroom lead, Subject Matter Expert preparation, QA checks, etc.)
• Lead/support the organization of mock regulatory inspections to identify internal site and CMO GMP risks and implement mitigation plans as required.
• Establish and monitor trends in regulatory inspection activities (internally/externally) and the Jazz Internal audit program to proactively identify potential areas of risk.
• Identify emerging regulatory/compliance trends, and inspection feedback/observations, to select topics for annual GMP training across the Manufacturing areas
• Lead and contribute to the development of continuous quality process improvements.
• Represent Manufacturing Quality Compliance within interdepartmental teams / project groups
• Maintain current training in accordance with the Jazz training curriculum
• This position may require up to 30-40% travel.

Required Knowledge, Skills, and Abilities
• 7+ years pharmaceutical or biotechnology industry experience
• Strong knowledge of GMP/GDP areas with demonstrated experience of inspection management
• Inspection experience with FDA, MHRA (or EU Competent Authorities) and other agencies
• Lead auditor experience in GDP/GMP areas.
• Knowledge in implementing/requirements of phase appropriate GMP with regard to manufacture and testing of IMP desirable.
• Excellent written and verbal communications skills.
• Self-directed and ability to take action as needed with oversight.
• Ability to collaborate and partner with various internal and external business partners
• Ability to work in a team environment
• Disciplined, detail orientated, and strong time management skills

Required/Preferred Education and Licenses
• Bachelor's degree in chemistry, biology or a related discipline.
• Lean Sigma certification preferred

Jazz Pharmaceuticals is an Equal Opportunity Employer
Dublin Ireland (+1 other)

Salary Criteria