Jazz Pharmaceuticals

Sr. Manager, Clinical Quality Assurance

US-CA-Palo Alto | US-PA-Philadelphia
3 months ago(9/19/2017 10:25 AM)
Job ID
2017-1251
# of Openings
1
Category
Research & Development

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

The Sr. Manager  Clinical Quality Assurance (CQA) supports the head of CQA to provide strategic planning and execution of the CQA program to ensure quality oversight of regulated Clinical and Non-Clinical / Early Development activities.

Key responsibilities include but are not limited to: Supporting the definition and maintenance of CQA processes through SOPs, development and management of audit plans to support R&D activities, representation on project team meetings, providing risk identification/mitigation support to potential or identified operational issues and deviations, managing audit activities for GCP, GLP, GVP related audits, leading and co-auditing of said audits, supporting inspection readiness activities and conduct of regulatory authority inspections, conducting quality review of clinical / non-clinical documents.

Essential Job Functions:

  • Manage the CQA audit program for assigned projects, including coordination of project allocation and ensuring all project assessments, audit schedules and plans are completed and cover areas of high risk. Proactively flag potential issues to head of CQA.
  • Plan and conduct GCP / GLP external and internal audits to assess compliance with regulatory requirements, investigational plans and company standards for clinical trial and early development / non-clinical related activities.
  • Communicate audit findings to stakeholders ensuring understanding as well as collaborating with auditees to develop CAPAs, addressing root causes.
  • Assess GCP / GLP compliance risk areas and support development and implementation of risk mitigation measures.
  • Perform quality reviews and provide input into clinical  and non-clinical documents to ensure compliance with Jazz Pharmaceuticals SOPs and regulatory requirements.
  • Provide quality assurance oversight to assigned project teams including representation on internal project team meetings and vendor meetings.
  • Provide guidance, interpretation and information on GCP / GLP regulations, standards and quality systems
  • Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.
  • Review and assess regulatory inspection commitments and CAPA plans for robustness.

Qualifications

  • Minimum of 5-7 years of academic, pharmaceutical or biotechnology industry experience, with at least 3 years in a quality assurance/regulatory compliance position.
  • Thorough knowledge and understanding of drug development and the clinical trial process .
  • In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.  Experience working in GLP environment and strong knowledge of GLP's is preferred.

Education

  • Bachelor’s Degree in Business or Life sciences is required.

Competencies

  • Excellent written and verbal communications skills with the ability to influence others and gain commitment.
  • Ability to work in an entrepreneurial and fast paced culture.
  • Must be disciplined, detail oriented and able to multitask and work efficiently and independently.
  • Ability to collaborate and partner with various internal business partners.
  • Ability to work in a team environment.
  • Highly developed problem solving skills and the ability to resolve difficult conflicts.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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