Director Quality, Development Projects
Category: Manufacturing | Country: Ireland | City: Dublin | Type: Regular, Full Time | Job ID: 4127
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The role of the Director is to provide leadership to the Quality Operations Development Projects Team to support the Jazz development pipeline from a scientific, quality and patient-centered viewpoint. It also includes management of development projects within the team. The position reports to the Senior Director, Quality External Manufacturing
The position is responsible for the management of the day-to-day Quality activities relating to development projects and providing technical support in relation to issues that can arise with Jazz development products, contract manufacturing organizations and material suppliers, to all applicable GXP standards. This role also includes cross functional team membership/collaboration and support for quality aspects of CMC regulatory dossiers.
Responsible for, but not limited to:
- Manage and direct the Quality Operations development projects team to ensure successful outcomes for development projects
- Liaising with the relevant departments within the business and working closely with the Quality Development Team to ensure agreed milestones/targets are met.
- Ensure and provide support to the Quality representatives on the CMC Product Team(s)
- Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country-specific regulations
- Work closely with Clinical Trial Management Supply Team to ensure supply of clinical trial material to clinical development programmes
- Provision of advice on technical issues that may arise for both small and large molecules including highlighting/directing the appropriate risk management.
- SME input to Product Quality Technical Agreements within the Quality Department as required
- Inspection readiness support for development products including development of playbooks
- Periodic QP support within Quality Operations in relation to both Commercial and clinical trial supply.
- Facilitating technology transfer, process scale-up and process improvement projects
- Management of external Quality consultants used to support development projects
- Serve as a member of Quality Council and prepare material as required
- Provide information to the Supplier Review Board in context of development projects
- Conducting vendor audits and vendor site visits as required
- Assisting in internal audits and regulatory agency inspections
- Provide SME technical support as required to the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required.
- Assisting with the transitioning of Jazz development products from the Investigational Medicinal Product space to Commercial Medicinal Product space
- Participation in due diligence activities associated with strategic partnerships or new company acquisitions as required
- Reviewing new critical regulations and guidelines, as they apply to product development from a quality perspective, and advising and assisting with implementation In Jazz where appropriate
- Communicate, where appropriate, with all corporate personnel and contribute to development projects 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 as they relate to development products in order to ensure compliance
- Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
- This position will require up to 20% travel
- Representation at external meetings from time to time
- Bachelor’s degree in chemistry, pharmacy or other related life science discipline
- Significant experience (5-10 years) in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms. or finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development and /or manufacturing areas or knowledge/experience
- Eligibility to act as a licensed Qualified Person
- Thorough understanding of Quality Systems and cGMP’s.as they relate to product development
- Experience with third-party vendor auditing, out of spec investigations, change control.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or working on regulatory submissions
- Highly organised, with good time management and prioritization
- Critical thinking and evaluation of process problems
- Excellent verbal and written communication skills
- Patient and results focused
- Good Leader and highly motivated.
- Collaborative team player
- Strong work ethic with a flexible and adaptable approach
Jazz Pharmaceuticals is an Equal Opportunity Employer.