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Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

BRIEF DESCRIPTION:

As a Director in the PDQA team you provide leadership to the PDQA QP Team and actively contribute to the quality oversight of the Jazz product development pipeline through clinical phases from a science-led, risk based and patient centric approach.
This position is responsible for the management of the day-to-day quality activities relating to pharmaceutical development 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.
The position reports to the Head of Drug Discovery and Pharmaceutical Development Quality.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• 10+ years of practical experience in the Pharmaceutical Industry in QA or QC role(s) with a thorough understanding of GMP and Quality Systems, as they related to product development.
• Ideally have significant experience (5-10 years) working in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms and finished pharmaceutical products.
• Ideally have significant experience working in pharmaceutical development quality.
• Proven track record of leadership and managing quality in a global organization.
• Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms.
• Experience working with contract manufacturing organizations.
• Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs and regulatory documents.
• Experience interfacing with regulatory bodies and working on regulatory submissions.
• Good technical and QA background, having a good understanding of analytical method development and validation and specification setting.
• Extensive experience in GxP regulatory compliance requirements, as they relate to early and late phase pharmaceutical development.
• Knowledge of US and EU GMP guidelines and their implementation for CMC product development.
• Ability to effectively lead and participate on multi-disciplinary teams.
• Ability to work independently with minimal direction.
• Ability to develop and manage a high-performance team driving a positive, inclusive and collaborative culture, in-line with Jazz Values.
• Highly organized, with good time management and the ability to prioritize.
• Critical thinker with the ability to evaluate complex problems.
• Excellent verbal and written communication skills.
• Strong work ethic with a flexible and adaptable approach.
• Careful attention to detail.
• Interpersonal skills and professional skills to interact at all levels, including senior executives, contractors, and colleagues.

REQUIRED/PREFERRED EDUCATION AND LICENSES

• Bachelor’s degree in chemistry, biology, pharmacy or a related discipline.
• Eligibility to act as a licensed Qualified Person
  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.
  The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html

• Act as a Qualified Person (QP) named on the Jazz Dublin MIA IMP.
• Lead the PDQA QP Team at Jazz Pharmaceuticals.
• Act as a PDQA representative on CMC product teams for assigned development projects.
• Ensure that the PDQA QP team provides appropriate support to the CMC matrix teams within Jazz Pharmaceuticals, ensuring that Phase Appropriate GMP is followed throughout the drug development process.
• Provide ‘Quality’ advice on technical issues that may arise for both small or large molecule development projects.
• Ensure the implementation of appropriate global Quality oversight, through Phase I - IV clinical phases of pharmaceutical development.
• Develop and initiate efforts designed to constantly improve and harmonize global processes and systems within PDQA.
• Work closely with the Clinical Trial Management Supply Team to ensure supply of clinical trial material to clinical development programmes.
• Interpret, communicate and implement changes in GMP, ICH and compliance related regulations, standards and practices, as related to pharmaceutical development.
• Promote a product understanding and risk-based approach to Pharmaceutical Development activities, ensuring that Quality Risk Assessments are performed and documented, identifying appropriate Critical Quality Attributes and Critical Process Parameters.
• Provide information and attend, when required, key meetings, such as Quality Management Review, Specifications committee, Pharmaceutical Development Review Committee and the Supplier Review Board, in the context of pharmaceutical development.
• Provide Quality review of CMC regulatory submissions, when required.
• Contribute and provide SME quality support for the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required.
• Act as lead auditor in third party vendor audits for IMPs, to include: GMP contract manufacturing, analytical testing and storage facilities when required to ensure compliance with Jazz requirements and country specific regulations.
• Ensure compliance of all contract manufacturers to both internal Jazz requirements and country specific regulations. To include person-in-plant support, when required.
• Prepare and/or act as an SME for Quality Technical Agreements within the PDQA Team
• Facilitate Technology Transfer, process scale-up and process improvement projects i.e. assisting with the transitioning of Jazz development products from the Investigational Medicinal Product space to Commercial Product space.
• Work closely with other members of the Technical Operations group to ensure delivery of key project objectives and timelines.
• Responsible for the successful, timely completion of goals and objectives within PDQA.