Associate Director PV Quality and Compliance
Category: Research & Development | Country: United States | State: Pennsylvania | City: Philadelphia | Type: Regular, Full Time | Job ID: 4193
Same Job Available In Two Locations
Philadelphia, Pennsylvania, United States
Palo Alto, California, United States
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.
The Associate Director, PV Compliance, this position is responsible for refining/improving, maintaining, and executing the PV Compliance program for Jazz. This leader will partner with the leader of PV Quality & Compliance to ensure compliance with global, local and regional PV legislation, regulations and internal policies and procedures. This position does have direct report responsibilities which includes but not limited to administrative duties (e.g. expense report approval, budgets, performance management).
Travel on short notice may be necessary to provide the support at alternative Jazz sites during business critical activities.
This role offers relocation.
- Refine, implement and ongoing maintenance of the PV Compliance Program across Jazz.
- Solve unique and complex PV issues/problems that have a broad impact on the organization.
- Identify and escalate PV issues of non-compliance and/or lack of urgency in remediation to senior leadership.
- Anticipate internal and/or external business challenges or regulatory issues as it relates to PV system including the PV quality system.
- Interact with business to develop appropriate compliance metrics to monitor PV activities that will provide qualitative and quantitative information to senior leadership
- Responsible for preparing and presenting routine compliance metrics in pharmacovigilance activities globally
- Participate in the call to action meetings to monitor the on-time completion of corrective action / preventative action against observations from inspections and audits, deviations, change controls, etc.
- 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
- Lead the 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 summaries as required to the appropriate leadership and teams.
- Where appropriate to facilitate improvements across Jazz, partner with the Clinical Quality & Compliance team members
- May be asked to participate in GCP or GLP quality or compliance projects or activities.
Required Knowledge, Skills, and Abilities
- Minimum 8 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.
- 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
- This position has direct reports. Proven ability in people leadership and performance management
- 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
- Lean Sigma certification, or equivalent certification, 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.
- 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.