Senior Manager PV Quality and Compliance
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4194
Same Job Available In Two Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, 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 Senior Manager, Pharmacovigilance Quality & Compliance is responsible for executing PV Compliance activities based on relevant regulations, procedures, and contractual requirements. Through implementation of quality and compliance tracking tools/reports, oversight strategy and relationship management, this role will support the development and management continuous improvements across the pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of all PV quality system related activities. The incumbent will support the organization and maintenance of PV compliance activities with metrics.
This role does not offer relocation.
- Lead or support (as determined by line management) PV process improvements including authoring controlled procedures as it relates to compliance activities, leading meetings of subject matter experts to revise procedures and merge procedures, as part of continuous improvements.
- Participate and support the development, design & maintenance of PV compliance metrics.
- Maintain documentation and reports for compliance continuous improvement activities.
- Establish operational objectives for the development, effectiveness evaluations, and compliance with PV systems and procedures. Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure alignment with PV regulatory requirements, industry best practices, and internal procedures.
- Contribute to the collection, organization, and presentation of global PV compliance metrics including vendor and partner oversight metrics.
- Applies in-depth knowledge to effectively assist in inspection related activities, pre-and post-inspection, such as backroom support and document request.
- Recognized as an expert in the PV Quality system, which includes supporting the management of issues, deviations, associated CAPA development.
- Interact with peers and colleagues to perform and monitor global pharmacovigilance regulatory intelligence to determine impact on pharmacovigilance system including the PV quality system.
- Assist in developing and monitoring PV commitments from internal audits, regulatory inspection findings, and CAPAs.
- Make contributions to the PV System Master File (PSMF) to ensure it is maintained on a regular basis.
- Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support the patient safety at the local level
- May be asked to participate in GCP or GLP quality or compliance projects or activities.
Required Knowledge, Skills, and Abilities
- Minimum 5 years business, pharmaceutical, or biotechnology industry experience
- Strong Good Pharmacovigilance Practices (GVP) is required
- Knowledge of Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) desirable
- Excellent written and verbal communications skills
- Ability to work in an entrepreneurial and fast-paced culture
- Self-directed and ability to take action as needed with limited oversight
- Ability to influence or gain acceptance from others in sensitive situations
- Ability to collaborate and partner with various internal and external business partners.
- Ability to work in a team environment
- Ability to work across geographical boundaries
- Disciplined, detail oriented, and strong time management skills
Required/Preferred Education and Licenses
- Bachelor’s degree in business or life sciences required
- 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.