Quality Director, Commercial QA

Quality Director, Commercial QA

Jazz Pharmaceuticals

Dublin, Ireland

Responsibilities:

Responsible for performing key Quality tasks in respect of the Company commercial products and specific projects from time to time. Work in the Quality function , within the Technical Operations Department, which oversees contract manufacturing operations, select supply chain operations and QP activities as well as providing support to internal Quality Systems. Reports directly to the Executive Director External Manufacturing Quality with responsibility for leading a team of direct reports.

This position is responsible for monitoring and supporting the quality performance of contract manufacturers, and material suppliers to all applicable standards for GMP and for QP activities in relation to commercial products. Also responsible for leading a team within Quality Commercial Product Operations.

Responsible but 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;
  • Provide weekly or bi-weekly CMO/Product status update to Senior Director External Manufacturing;
  • Lead and manage a QA team, including setting goals, performance review, training, development and budgeting;
  • Ensure timely disposition of commercial products and related QP activities within the team;
  • Oversee Product Quality Review and annual report completion on time and suggest new ways to improve this process;
  • Facilitating technology transfer, process scale-up and process improvement protects;
  • Building authentic relationships and leading business meetings and audits where appropriate of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs);
  • Assisting 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 commercial drug products to all markets 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 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 against an agreed 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.

Other Responsibilities:

  • Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest;
  • Communicate as required to Commercial Product Governance Team on activities that relate to external manufacturing activities;
  • Attend as required internal committees such as Quality Council;
  • 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;
  • Provide quality representation to the Commercial Products Product team and advise as appropriate.

Professional Competencies:

  • 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;
  • At least 10 years’ experience gained in finished product pharmaceutical manufacturing with knowledge of biotechnology products and drug substance manufacture is desirable;
  • An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry;
  • Proven track record in people management and personnel development;
  • Customer orientated with excellent communication skills with an ability to apply pragmatic logic to problem solving and issue resolution.

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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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