Our client is a very fast expanding global pharmaceutical company
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 Senior Director Quality and Commercial Operations with responsibility for leading a team of direct reports.
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. Also responsible for leading a team within quality and Commercial Operations. This individual will receive assignments in the form of goals. The individual is responsible for, but is not limited to:
- Managing product quality related priorities and tasks at the respective contract manufacturers
- Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, change controls and leading product related investigations
- Lead and manage a QA team, including setting goals, performance review, training, development and budgeting
- Designing, Implementing and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training
- Facilitating technology transfer, process scale-up and process improvement protects
- Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs)
- Leading and assisting in internal audits and regulatory agency inspections
- Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets.
- 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, 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.
- Evaluate proposed changes to the manufacturing and supply chain processes, and authorize these changes, if appropriate.
- Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
- Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate.
- Ensure compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations
- Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimize such risks
- 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 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
A Masters or PhD level in a science discipline is required, with an excellent understanding of quality assurance. Qualified person status and experience is required. 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, biotechnology products 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.
- 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