Sr Director, PV Quality Compliance
Palo Alto, CA  / Philadelphia, PA 
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Posted 1 day ago
Job Description
Sr Director, PV Quality Compliance
Job Locations US-CA-Remote Non Sales-USA | US-PA-Philadelphia | US-CA-Palo Alto | UK-Oxford
Job ID 2021-5715
Category Research & Development
Overview

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.


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 Head of PVC is responsible for developing and executing Pharmacovigilance (PV) quality and compliance programs in support of in-development and marketed products. As a strategic leader, the incumbent will work closely with the PV leadership team and PV sub-functions to assure that PV activities are conducted in compliance with regulatory requirements, the Jazz Pharmaceutical Quality Management System and established internal procedures with patient safety always at the forefront

The Head of PVC will partner with the R&D quality, Regulatory, Commercial and Corporate teams, as well as vendors and internal stakeholders and business partners

This leader will manage a team of Compliance subject matter experts that will optimize procedures and practices, and develop and deliver programs to monitor and communicate compliance. The team will also support the PV department in Issue, Deviation and CAPA management and in preparing and participating in audits and inspections. The Head of PVC will also oversee due diligence activities from the perspective of PV operations and compliance assessment.

Essential Functions

    Leads and manages the PVC team in the delivery of the various quality and compliance programs including but not limited to oversight quality control of PV data, compliance monitoring, and review of quality system records and activities.
  • Plans budgets and people resources to effectively deliver the applicable quality and compliance programs for the in-development programs, post marketed studies and marketed products.
  • Contributes to the strategy, development and implementation of the R&D quality management system and review process including the facilitation of the applicable R&D Quality Councils according to defined charters.
  • Develops strategy for defining and implementing the applicable quality and compliance programs to ensure the global Jazz pharmacovigilance system, and quality management system are achieving standards for patient safety activities conducted and managed in accordance to applicable GxPs, regulatory requirements, guidelines, laws and established company standards.
  • Performs review of key quality and compliance performance indicators; identifies and escalates quality and compliance risks appropriately to senior management and business partners.
  • Provides resource and process for due diligence activities when assessment of PV operations is required for potential business endeavors.
  • Establishes practice of sharing significant issues and lessons learned, and managing key activities to mitigate risks to products in-development and in the market
  • May serve as Co-chair of applicable Quality Councils.
  • Partners with the R&D business and other quality teams on continuous improvement projects as assigned.
  • Participates in regulatory and compliance intelligence and surveillance activities (through agencies and professional groups) to observe and recognize new or changing worldwide regulatory and compliance developments and enforcement trends and to recommend appropriate plans and actions for PV
  • Coach and mentor staff ensuring appropriate levels of accountability for delivering according to Jazz core competencies and values, and clearly communicate across Jazz.
  • Hold employees accountable to deliver individual and department objectives within timelines and budgets.
  • Measure performance through defined performance, quality and compliance metrics.
  • Model and encourage adherence to the Jazz Values and Mission.

Required Experience

  • At least 10 years pharmaceutical or biotechnology industry experience in PVC roles
  • At least 5 years of strategic leadership and line management in PVC activities

Required Knowledge, Skills, and Abilities

  • Expert in GVP, strong knowledge of GCP a plus.
  • Expert knowledge and skills in Quality Management Systems
  • Track record of delivering successful quality and improvement projects through use of teams
  • Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
  • Exceptional written and verbal communication skills

Required/Preferred Education and Licenses

  • Bachelor's Degree in Business or Life sciences is required, advance degree is preferred

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.

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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Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
10+ years
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