This position will be primarily providing support to PV Quality & Compliance Director in
- Leading the preparation for, and hosting of Regulatory Authority inspections at Jazz’s primary U.S. site which is in Palo Alto, CA, internal and external audits.
- Ensuring compliance with global, local and regional PV regulations and Jazz’s policies/procedures
Inspection readiness will be focused in GVP, but is not limited to GVP and may include support for Good Clinical Practice, Good Distribution Practice, Good Manufacturing Practices, and other Marketing Authorization Holder inspections where there are PV touchpoints.
As a global leader, this role is expected to travel at short notice in order to provide the support at alternative Jazz sites.
- Partners with Clinical Quality & Compliance to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks.
- Collaborates with local site teams (e.g. IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and audits
- Prepare subject matter experts, and their back-ups, to present their functions during audits and aid in creating storyboards.
- Work with business to develop appropriate corrective action / preventative action against observations from inspections and audits
- Track all relevant corrective action / preventative action details from inspections and audits to completion
- Escalates issues of critical noncompliance and/or lack of urgency in remediation to senior leadership.
- Track ad hoc regulatory requests and responses as they pertain to Pharmacovigilance.
- Assist with gathering and presentation of routine compliance metrics in pharmacovigilance activities globally
- Develop and implement monitoring programs to ensure regulatory requirements for PV requirements are complied with and risks are minimized. Facilitate early detection of potential compliance issues and subsequent timely reporting to the relevant global, and regional stakeholders
- Support the development of trending analysis of inspection and audit outcome data to identify business or development program risks in collaboration with the R&D Analytics team
- Provide consultative support to the business with the purpose of continuous improvement
- Upon notification of a regulatory inspection or internal audit initiates and supports the inspection team to prepare and submit pre-inspection document requests, logistics, and execution. Preforms inspection host responsibilities when required.
- Ensures that company communications are sent regarding the start and end of inspection activity, and Provides daily summary to Sr. Leadership.
Required Knowledge, Skills, and Abilities
- 10+ years working knowledge / experience of pharmaceutical experience
- Extensive knowledge and demonstrated experience in GVP.
- Knowledge and experience with GCP, GLP, and GDP are highly desirable.
- Advanced inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus
- Ability to work across geographical boundaries with strong leadership and ability to inspire colleagues
- Sound judgment and decision making skills
- Must be able to influence and motivate others without authority
- Action and results orientated
- Project management skills preferred
Required/Preferred Education and Licenses
- Bachelor’s degree is required; Master’s degree in management, leadership or scientific discipline a plus
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.