Johnson & Johnson

Helaas, deze vacature is niet langer actief

Originele vacaturetekst

Director, QP Release, Vaccines

Job Description

Janssen Supply Group is recruiting for a Director - QP Release located in Leiden, The Netherlands or other EU based locations.

In this position you will the manage a team of Qualified Persons responsible for release of vaccine products for which Janssen Biologics is either the marketing authorization holder or is filed as the releasing site. You will also provide leadership to a team of quality assurance associates responsible for managing the processes supporting the EU Official Control Authority Batch Release and Marketing Information Forms, and work closely with internal stakeholders to define the product release flows and the strategy for National Control Laboratory testing and certification requirements for EU, NGO, ROW, and emerging markets for the Janssen vaccine programs.

The position requires extensive knowledge in the execution of quality systems related to the manufacture of vaccine products and Global Health Authority Regulations, Pharmaceutical and Biologics Quality Assurance, Quality Control, and Regulatory and Compliance, and may require travel to External Manufacturing sites to provide cGMP assistance and quality oversight.

Key Responsibilities:
  • Represent External Quality in the batch certification and release of vaccines products.
  • Lead a team of QPs responsible for review of batch documentation for Janssen vaccines products prior to their release.
  • Define the product release flows and the strategy for National Control Laboratory testing and certification requirements for EU, ROW, and emerging markets for the Janssen vaccine programs
  • Lead a team of quality assurance associates responsible for managing the processes supporting the EU Official Control Authority Batch Release and Marketing Information Forms
  • Support regulatory inspections at both internal and external manufacturing sites when necessary, including direct interactions with regulatory inspectors.
  • Evaluate and approve regulatory documents with respect to vaccine registrations.
  • Maintain end-to-end quality oversight of the supply chain for vaccine products released by Janssen Biologics.
  • Approve change controls, deviations and non- conformities for Janssen vaccine products as necessary
  • Escalate significant issues to senior leadership and provide input on decisions related to health authority communications and field actions.
  • Represent QP functions during new product introductions
  • Serve as point of contact and subject matter authority within the QA organization for quality related projects and issue management.
  • Ensure that personnel are recruited and trained to perform their required job functions.
  • Develop an innovative thinking and Credo based culture in which every associate is valued and recognized for their contribution to our success.
  • Partner with key supporting functions including PQM, Compliance, regulatory,and internal Site QA, to ensure all activities within external manufacturing are carried out in compliance with corporate, cGMP and other regulatory requirements.
  • Pro-actively identify risks and potential issues and lead resolution.
  • Assess current quality systems and recommend improvements in order to improve quality and reduce cycle time. Monitor trends, identify issues, recommend and implement appropriate actions.
  • Provide leadership that ensures quality and compliance activities related to QP release function are carried out appropriately.
Qualifications

Education:

  • Bachelor's Degree in (bio)chemical, Pharmaceutical, Scientific or Technical field is required; Advanced degree (MS, MBA) is preferred;
  • QP License is required.
Experience and Skills:Requirements:
  • A minimum of 10 years experience in Pharmaceutical OR Biotech OR Medical Device or highly regulated environment is required.
  • Experience with manufacturing and/or Quality for Vaccines or Large Molecules and or Sterile products is required
  • Experience in both drug substance and drug product manufacturing is preferred
  • Experience in External Manufacturing, Quality Management and/or Quality System Development is preferred;
  • In depth knowledge of global cGMP requirements and ISO requirements is required;
  • Knowledge of Sterile manufacturing processes, including aseptic processes is required.
  • Advanced knowledge and confirmed application of Process excellence tools is preferred.
  • A minimum of 8 years people management experience is required
  • Strong collaboration, mentoring, and coaching skills are required
  • Excellent written and verbal communication skills, with an open and interactive leadership style required
Other:

Up to 30% domestic and international travel may be required

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality
Requisition ID
2105982139W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist