Jazz Pharmaceuticals, Inc. Temporary Associate Director Quality in Dublin, Ireland
Temporary Associate Director Quality
Quality Sciences (COGS)
Responsible for performing key Quality tasks in respect of Company products and development projects. Work in the Quality Group, within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions as well as internal Quality Systems. Reports directly to the Executive Director Quality and Commercial Operations.Responsibilities: This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors and material suppliers to all applicable standards for GMP and GDP. This individual receives assignments in the form of goals. The individual is responsible for, but is not limited to:
Lead Quality product, process and business related projects using project management and project execution tools to deliver the agreed project objectives on time and to budget
Agree the Project charter with key stakeholders, including resource requirements and
Facilitate the gathering of business needs, use case and solution criteria.
Track and manage the identification and resolution of Project Issues and Risks
Communication and rollout the new framework across the organisation including training for
all applicable Departments
Manage clinical trial material, CTM, quality related priorities and tasks at the respective contract manufacturers
Lead and monitor the clinical trial material operations at the Contract Manufacturer, perform batch review and QP disposition, review and approve related complaints, deviations, change controls and lead product related investigations
Facilitate and lead process scale-up, technology transfer and process improvement projects
Build authentic relationships, lead business meetings and audits of critical CTM suppliers and contract manufacturers and maintain all clinical trial material related Quality Technical Agreements (QTAs)
Lead and assist in internal audits and regulatory agency inspections
Ensure compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations
Highlight any risks associated with maintaining supply of clinical trial material to all stakeholders and offer innovative and effective ways to minimize such risks
Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of clinical trial material to the sites
Participate in due diligence activities associated with strategic partnerships or new company acquisitions
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, service providers, packagers and laboratories, as required.
Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP activities. In this respect, it may be necessary to collaborate with the regulatory affairs department and liaise with regulatory agencies in the process of resolving GMP specific quality issues.
Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate. Roll out training as appropriate.
Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.
Contribute to the design and implementation of best practice quality improvement projects and programmes and company expansion programmes.
Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
Professional Competencies: A Degree or Masters level in a science discipline is required, with an excellent understanding of quality assurance. Qualified person status is desirable. A strong understanding of, and experience in quality management is essential with a proven track record in people management and personnel development.At least 10 years’ experience gained in finished product pharmaceutical manufacturing is required. Knowledge of QA for all pharmaceutical dosage forms and drug substance manufacture is desirable. An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required. Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution is also required.Personal Competencies:
Authentic leadership aligned with the core company values to enable the pursuit of excellence.
Collaborative Team Player with good interpersonal skills
Patient and Results Focused
Strong Communication Skills
Integrity in words and actions
Ability to Adjust to and Manage Change
Show Resilience, be Flexible and Adaptable
Facilitate Creative and Innovative solutions