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Director, Qualified Person

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Vertex Pharmaceuticals

3mo ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You must have EU/UK GMP expertise, strong leadership, communication, and collaboration skills, a QP background, risk evaluation ability, knowledge of cell and gene therapy, and a bachelor’s degree.
  • You will lead QP functions, design talent strategies, resolve compliance issues, manage QMS, negotiate with regulatory bodies, and advise cross-functional teams on QP matters.

Requirements

  • In-depth regulatory agency knowledge and experience in EU and UK GMP requirements with current knowledge of industry trends and best practices.
  • Excellent communication skills
  • Work cross-functionally with all levels to foster exceptional collaboration.
  • Proficiency in using Microsoft Office applications required
  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Good understanding of cell and gene therapy
  • Experience in leading teams across different jurisdictions
  • Bachelor's degree
  • Ability to act as a Qualified Person in accordance with the EU Guide to Good Manufacturing Practice in article 51 of Directive 2001/83/EC
  • Extensive experience as a QP and leading QP teams.

Responsibilities

  • Responsible for leading the Vertex QP function supporting Vertex clinical and commercial product portfolio release to the UK and EU markets.
  • Designing the QP talent acquisition and management strategy to support current and future Vertex product programs and supply in UK and EU markets.
  • Partners with critical contract manufacturers to escalate and resolve compliance issues in clinical and commercial supply chains, interfaces with customer/partner quality organisations, and negotiates third party contractor and supplier quality agreements.
  • Ensure that the QMS implemented and maintained, including the management of authorised activities and quality of records.
  • Provide technical leadership and advice for key quality/ batch certification issues.
  • Negotiation with regulatory agencies on behalf of Vertex regarding matters relating to QP batch certification and license related matters.
  • Develop and implement the QP strategy for the organisation, including but not limited to:
  • creating the framework for leadership alignment on decisions regarding QP release strategy for all Vertex clinical and commercial programs.
  • advising cross functional teams and leaders of QP related matters.
  • Providing the future QP direction and forum for alignment for clinical and commercial programs
  • Ensure Manufacturers Importation Authorisation (MIA) licenses accurately reflect the current organisation activities.
  • In-depth and comprehensive understanding of QP/ batch certification concepts and principles expanding to QP integration with all facets of the organization/ industry sector. Representing Vertex QP organisation in this forum and shaping future regulatory requirements in QP space.
  • Member of international Quality Leadership team and Global QP Governance Committee representing QP team.

FAQs

What is the primary responsibility of the Director, Qualified Person role?

The primary responsibility of the Director, Qualified Person role is to provide expertise and leadership to the QP team, develop the QP strategy for the Vertex product portfolio, and ensure compliance in the certification and release of licensed and clinical products.

Is travel required for this position?

Yes, this role will require travel to the UK and US as necessary.

What qualifications are necessary to apply for this position?

A Bachelor's degree and the ability to act as a Qualified Person in accordance with the EU Guide to Good Manufacturing Practice are necessary, as well as extensive experience as a QP and leading QP teams.

What kind of experience is preferred for candidates applying for this role?

In-depth regulatory agency knowledge and experience in EU and UK GMP requirements, experience in leading teams across different jurisdictions, and a good understanding of cell and gene therapy are preferred.

What skills are required for the Director, Qualified Person role?

Required skills include excellent communication, strong leadership abilities, proficiency in Microsoft Office applications, and the ability to evaluate quality matters using a risk-based approach.

Will the Director, Qualified Person interact with regulatory agencies?

Yes, the Director will act as the primary point of contact for regulatory agencies concerning batch certification activities and associated licenses.

Is Vertex committed to diversity in employment?

Yes, Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to various protected characteristics.

What is the role of the Director in relationship to contract manufacturers?

The Director will partner with critical contract manufacturers to escalate and resolve compliance issues and negotiate third party contractor and supplier quality agreements.

How does the Director contribute to quality management systems?

The Director ensures that the Quality Management System (QMS) is implemented and maintained, including the management of authorized activities and the quality of records.

What is the role of the Director within the International Quality leadership team?

The Director will be a member of the International Quality leadership team, representing the QP organization and shaping future regulatory requirements in the QP space.

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Vertex Pharmaceuticals

The Science of Possibility

Science & Healthcare
Industry
1001-5000
Employees
1989
Founded Year

Mission & Purpose

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.