Sr. Manager, Quality Metrics 6/3/2020
Palo Alto, CA
JOB DESCRIPTIONAPPLY 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.
This position is responsible for managing key activities in support of ensuring alignment and effectiveness in the delivering of objectives related to R&D Quality Assurance. This position has multiple responsibilities which include but are not limited to developing key quality performance metrics and performing risk assessments. A large focus of this role is the execution of cross-functional projects across R&D and participation in global projects that impact quality and compliance. S/He will support critical planning efforts, including executing cross-functional projects plans, communication and training plans, resource allocations and key deliverables dedicated to the R&D and Jazz initiatives and goals.
* Implement R&D quality management review metrics and dashboard and presents R&D quality and compliance health to the Clinical and PV Quality Councils.
* Performs analysis of key quality and compliance performance indicators for the development of reports in support of R&D Quality Management Review program and R&D Quality Councils.
* Serve as a project lead for projects varying sizes within R&D Quality and across the R&D organization and sometimes across Jazz to incorporate/align internal standards and GxP requirements into R&D processes, procedures, and tools or technologies.
* Supports the identification of cross-functional dependencies, gaps, risks, and issues, and mobilizing relevant team members and resources toward resolution of issues and alignment on critical decisions.
* Provides leadership to internal and external team members necessary to execute the proactive quality program.
* Perform other activities as directed by R&D Quality Management.
* Participate in regulatory intelligence and surveillance activities (through agencies and professional groups) to observe and recognize new or changing worldwide regulations.
* Model and encourage adherence to the Jazz Values and Mission.
* Evaluate processes for potential improvement in efficiency and effectiveness and recommend changes.
* Maintain a state of inspection readiness.
Required Knowledge, Skills, and Abilities
* Minimum 10 years business, pharmaceutical or biotechnology industry experience
* Data analytics and statistical experience is required.
* Ability to collaborate and partner with various internal and external business partners including peers and senior leaders.
* Excellent written and verbal communications skills with an ability to influence through fact and knowledge based arguments.
* Understanding of Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP).
* Advanced user of MS Excel or similar tools for generating charts and graphs.
Required/Preferred Education and Licenses
* Bachelor s Degree in Business or Life sciences is required, advance degree is preferred
* Lean Six Sigma certification preferred but not required
Description of Physical Demands
* Occasional mobility within office environment.
* Routinely sitting for extended periods of time.
* Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
* Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
* Frequent computer use at workstation.
* May move from one work location to another occasionally.
* Responsibilities may require a work schedule that may include working outside of normal work hours, in order to meet business demands.
* Occasional public contact requiring appropriate business apparel.
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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