Clinical Quality Assurance Manager

If you are a 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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

To support Clinical Quality Assurance in its application and development of the Quality Management System and provide expert regulatory guidance and quality support to functional departments involved in all aspects of clinical trials. Prepare, perform, report and follow-up independent Clinical Quality Assurance audits including associated quality management activities and provide input into the audit schedule. Acts as Lead auditor or mentor as applicable.

Essential Functions/Responsibilities

• Support the implementation of the global quality management system
• Competent and experienced senior auditor for GCP and PV (related to clinical studies).
• To plan, conduct, report or support GCP, GPvP, GVP, to CQA audit programmes in order to verify compliance with appropriate regulations, guidelines and appropriate company SOPS
• Acts as an ambassador to protect the rights and wellbeing of all participants in drug development activities on behalf of the company
• To understand and apply appropriate guidelines and regulations, including ICH, FDA, MHRA and EMA and other worldwide regulations, in a risk-based manner to Clinical Studies/Trials, including Pharmacovigilance activities and quality vendor management
• CQA Quality Lead for Clinical Quality Assurance to support Study teams, providing quality support and regulatory requirements advice/guidance for multiple clinical studies/trials
• Create and Manage Study Quality Oversight and Audit Plans
• Conduct Study Quality Reviews and assess/verify GCP Statements
• To assist with the preparation for GCP/GPvP inspection readiness and hosting of inspections by national and international regulatory bodies at Jazz and Investigator Sites
• To report quality issues or non-compliance to the Associate Director CQA and client groups, where appropriate, that are detected whilst carrying out duties for Good Clinical Practice (GCP), and other relevant GxP activities
• To review and assess quality issues or non-compliances and associated corrective and preventative actions to ensure the investigation and actions implemented were appropriate and risk-based in accordance with applicable guidelines and regulations, including ICH, FDA, MHRA, EMA and other worldwide regulations
• To assist the Associate Director CQA with the promotion of quality awareness among Jazz, vendors and investigator site personnel
• To mentor/train, provide support and guidance to members of the CQA team
• To maintain current Health and Safety knowledge applicable to the job and/or Company requirements

Required Knowledge, Skills, and Abilities

• Typically, 7+ years relevant work experience in the Pharmaceutical, Biotechnology or a related industry
• Demonstrable QA compliance experience and an understanding of applicable GCP regulations and guidelines and some working knowledge of pharmacovigilance regulations and guidelines

• Demonstratable knowledge and experience in audit principles, procedures and techniques
• 5+ years' experience in GCP auditing and Lead auditor for at least three disciplines (eg investigator site audits, vendor audits, internal process audits, healthy volunteer audits, GCLP, and GVP audits)
• Knowledge and experience of working to pharmaceutical regulatory standards in clinical research and knowledge of international regulatory requirements for product registration
• Experience with Oncology and Neuroscience clinical studies/trials

Skills:

• Working knowledge of office IT packages
• Good level of written and verbal communication skills
• Good organisational skills, with the ability to multi-task, including the ability to work independently or as part of a team, to agreed deadlines
• Positive thinking and excellent attention to detail
• Excellent investigative/analytical skills
• Understands risk within clinical trials and is able to apply a risk-based approach to both clinical studies and CQA activities
• Understands and can demonstrate the principles of quality by design in relation to clinical trials
• Demonstrable leadership skills with the ability to confidently lead, direct and motivate others

Attributes and Behaviours:

Proven organisational and interpersonal skills, demonstrated through the following competencies:

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services.
• Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn't misrepresent him/herself for personal gain.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative.
• Functional/Technical skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Action Orientation: Enjoys working hard; is action orientated and full of energy for things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities that others.
• Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product or technical knowledge; does well in technical courses and seminars.
• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Presentation Skills: Is effective in a variety of formal presentation settings: one-on-one, small and large groups, with peers, direct reports, and bosses; is effective both inside and outside the organisation, both of cool data and controversial topics; commands attention and can manage group processes during the presentation; can change tactics midstream when something isn't working.
• Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Self-development: Is personally committed and actively works to continuously improve him/herself; understands that different situation and levels may call for different skills and approaches; works to deploy strengths; works on compensating for weakness and limits.

Required/Preferred Education and Licenses

Knowledge:

• Bachelor's degree in science or related discipline
• Post-graduate qualifications (Master's, PhD) preferred
• Trained and competent Lead Auditor (ISO9001 or equivalent)

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.

Jazz Pharmaceuticals is an Equal Opportunity Employer.