Jazz Pharmaceuticals

Quality Assurance Manager IMP (1 year Fixed Term)

Job Locations IE-Dublin
Posted Date 1 month ago(1/22/2018 5:51 AM)
ID
2017-3322
# of Openings
1
Category
Manufacturing

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. 

Position Profile

Description

Responsible for developing and maintaining Quality Systems and Vendor Management activities 

The position is responsible for monitoring and supporting the quality performance of contract manufacturing organisations (CMOs) and material/service suppliers to ensure that all operations are fully in compliance with current international standards for cGMP. Specifically, this position is responsible for Quality oversight of CMOs/vendors of Jazz Investigational Medicinal Product, used in Jazz sponsored clinical studies in support of new product introduction and existing product development during lifecycle management.

  • Lead and/or support quality oversight of Jazz GxP contractors as required including manufacturing, analytical testing, packaging and distribution. Monitor daily operations at the contract site including batch review and disposition, review of stability data, deviations, OOS investigations, change controls, complaints and other quality systems.
  • Oversight of non-routine manufacturing/packaging activities at the contractor site.
  • Work with and ensure compliance with the GxP vendor qualification programme including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
  • Act as lead auditor in third party vendor audits as per the Jazz audit schedule.
  • Be a key member of company audit team during regulatory or customer audits. Ensure a state of constant readiness for unannounced regulatory inspections.
  • Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company, including, but not limited to Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, Training, Artwork approval, Validation and qualification.
  • 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.
  • Provide QA and technical support to key company pre-and post-approval development activities such as: Manufacturing site transfers and process scale-up; Product life cycle maintenance activities and new product launch; Analytical method qualification & method transfer; Integration activities following product acquisition and Product formulation development.
  • Build authentic relationships and lead business meetings and audits of critical suppliers and contract manufacturers and maintain all product-related Quality Technical Agreements (QTA’s).
  • Participate in and provide critical analysis of business diligence visits.


Other Responsibilities:

  • Work closely with other members of the Technical Operations group to ensure delivery of key project objectives and timelines
  • Work directly with other key Company departments to ensure compliance and productive working relationships.
  • Assist with troubleshooting quality issues at Partner’s or vendor’s site, when required.
  • Integrate, contribute, and/or lead cross-functional project teams as required. Support projects schedules as required.
  • Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.

Professional Competencies:

  • Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree in pharmaceutical science desirable.
  • Significant experience (5-10 years) working in finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
  • Eligibility to act as a licensed Qualified Person is extremely desirable.
  • Thorough understanding of Quality Systems and cGMPs.
  • Experience with and fundamental understanding of FDA / EU regulations, associated guidance documents and in interfacing with regulatory bodies or working on regulatory submissions
  • Experience in the following desirable: Biological/Sterile product manufacturing, both clinical and commercial.
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, partners and colleagues.
  • Experience working with contract manufacturing organisations

Personal Competencies: 

  • Highly organised, with exceptional time management and prioritisation
  • Critical thinking and evaluation of process problems
  • Excellent verbal and written communication skills
  • Patient and results focused
  • Good Leader and highly motivated.
  • Collaborative team player
  • Strong work ethic with a flexible and adaptable approach.

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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