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Technical Director of Quality, Development Projects, Quality Operations

Dublin, Ireland | Jazz Pharmaceuticals

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Operations / Production
  • Experience:
    10-12 years
Job Description:
116 people have viewed this job

Overview:

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. 


Responsibilities:

The role of the Technical Director is to provide technical 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 Director of Quality, Development Projects, Quality Operations.


Responsibilities:


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:


Provide advice on technical issues that may arise for both small and large molecule projects including initiating/directing appropriate risk management

Act as a Qualified Person (QP) named on Jazz Pharmaceuticals Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products to ensure clinical trial supply

Provide SME technical support for the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required

Liaise with the relevant departments within the business and work closely with the Quality Operations Development Projects Team to ensure agreed milestones/targets are met

Act as a quality representative on CMC Product teams for assigned development projects

Ensure and provide support to the Quality representatives on the CMC Product Team(s)

Ensure compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations

Work closely with the Clinical Trial Management Supply Team to ensure supply of clinical trial material to clinical development programs

Prepare and/or act as an SME for Quality Technical Agreements within the Quality Department, as required

Facilitate technology transfer, process scale-up and process improvement projects i.e. assist with the transitioning of Jazz development products from the Investigational Medicinal Product space to Commercial Medicinal Product space

Provide information to the Supplier Review Board in the context of development projects

Conduct vendor audits and vendor site visits, as required

Review new critical regulations and guidelines, as they apply to product development from aquality perspective, and advise and assist with their implementation in Jazz

Responsible for the successful, timely completion of goals and objectives which will strengthen Jazz Quality Operations, Development Projects team

Provide periodic QP support within Quality Operations to support commercial manufacture

Other Responsibilities:


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 programs and company expansion programs

Contribute to the development of quality policies and procedures as they relate to development products in order to ensure best practice and compliance

Contribute to the development of new drug products, which will deliver a robust product pipeline without significant delays in the regulatory approval process

Work closely with other members of the 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

Act as a Development Projects Quality representative at external meetings

Professional Competencies:


Bachelor’s degree in chemistry, biology, pharmacy or a related science discipline

Eligibility to act as a licensed Qualified Person

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 relate to product development

Ideally have significant experience (5-10 years) in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms and finished pharmaceutical products

Experience with third party vendor auditing, out of specification investigations, deviations, product complaints and change control

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

Knowledge of US and EU GMP guidelines and their implementation for CMC product development

Personal Competencies:


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

Patient and results focused

Good Leader

Highly motivated

Collaborative team player

Strong work ethic with a flexible and adaptable approach

Careful attention to detail

Articulate, computer literate, problem solving, decision taking, inter-personal and influencing skills

Good people skills and experience in management of a team required

Interpersonal skills and professional skills to interact at all levels, including senior executives, contractors, and colleagues


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