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QA Manager


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

Quality lead on Jazz development project teams. Responsible for Quality oversight 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 Biologics Investigational Medicinal Product across all phases of the clinical development lifecycle. Reporting directly to Director, Quality Development Projects.

Essential Functions:

Responsible for, but not limited to:

• Quality oversight of Biologics DS and DP process/product development and clinical manufacturing/analytical testing/packaging.

• QA Lead on internal Jazz and external CMO cross functional teams for development projects

• Quality oversight of process and analytical qualification and validation in accordance with phase appropriate regulatory requirements

• Monitoring operations at the contract site including batch review and disposition, review of stability data, deviations, OOS investigations, change controls, and other quality systems.

• Provide QA support to project teams and participate in strategies for product development and obtaining regulatory approval.

• Collaboration with contract manufacturers, packagers and testing laboratories to resolve any quality issues.

• Collaboration within Jazz cross functional CMC teams to resolve any quality issues.

• Ensure compliance with the GxP vendor qualification programme including initial and ongoing qualification

• Conducting vendor audits and vendor site visits as required

• Assisting in internal audits and Jazz or CMO regulatory agency inspections

• Support the product stability program for IMPs

• Contribute to the development of quality policies and procedures as required

• Generate and maintain Product Specification Files (PSFs), QP declarations, Supply Chain Flows

• Review and approval of IMP product artwork/labelling

• Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company.

• Support supply chain with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.

• Contribute to regulatory submissions

• Build authentic relationships with 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.

• Work closely with other members of 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.

Required Knowledge, Skills, and Abilities

  • Significant QA experience (5-10 years) working in biologics/sterile manufacturing.
  • Eligibility to act as a licensed Qualified Person is extremely desirable
  • Working knowledge and experience of CMC regulatory and quality requirements for phase 1 through post approval, both US and EU.
  • Thorough understanding of Quality Systems and phase appropriate cGMP's.
  • Experience leading third party vendor audits
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
  • Experience working with contract manufacturing
  • Experience interfacing with regulatory bodies or working on regulatory submissions
  • 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, decision maker and highly motivated.
  • Collaborative team player
  • Strong work ethic with a flexible and adaptable approac

Required/Preferred Education and Licenses

  • Bachelor's degree in chemistry, biology or a related discipline
  • Eligibility to act as a licensed Qualified Person is extremely desirable
  • GMP lead auditing certification is desirable

Description of Physical Demands

  • Responsibilities may require working outside of "normal" hours, in order to meet business demands.
  • Requires international travel for oversight of manufacturing/packaging activities at the contractor site as Jazz QA person in plant.

Jazz Pharmaceuticals is an Equal Opportunity Employer.

QA Manager

Full Time

Published on 05/12/2020