FSP Quality Manager

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description
1PURPOSE OF THE FUNCTION
* The Global Patient Safety (GPS) Quality Management Manager is responsible for the operational execution of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area.
* This position will also:
* Contribute to driving the growth of the GPS Quality Management function.
* Maintain & execute the Comprehensive Training Program.
* Manage GPS Procedural Document activities
* Participate in GPS Audit & Inspection Readiness, Support & Management.
* Contribute to GPS Continuous Improvement (Issue Management, Process improvement, KPI development). 2REPORTING LINE
* Associate Director, GPS Quality Management or above 3ROLES AND RESPONSIBILITIES GPV internal Audit program and Inspection activities:
* Support, and/or manage GVP Audit & Inspection activities
* Support internal global GVP audit program and inspection readiness activities in collaboration with the client Quality functional area.
* Prepare GPS team members on inspection readiness activities.
* Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
* Support the coordination and preparation of GPS responses to audit &inspection findings. Deviation & Corrective and Preventive Action (CAPA) activities:
* Assess GPS issue management trends and implement actions plans to mitigate systemic causes.
* Identify internal deviations and support / advise GPS team in determining corrective and preventive actions.
* Support/guide the GPS team to determine root cause of issue to avoid recurrence.
* In collaboration with the client Quality functional area, lead the implementation of corrective or preventive actions. Training, Procedural Document, & Record Management activities:
* Contribute to the development of the Pharmacovigilance training program.
* Maintain, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc).
* Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
* Support the monitoring, maintaining, re-evaluating and updating the GPS training curricula
* Provide training to relevant client employees and 3rd parties (when applicable)
* Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS process & procedures.
* Participate in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
* Support document control through use of Veeva System. GPS Performance & Compliance activities
* Contribute to development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.
* Support monitoring of compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff
* Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables.
* Support monitoring the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
* Support the compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners Other Activities:
* Perform other tasks and duties as assigned by line manager or GPS Leadership 4SKILLS AND COMPETENCIES
* Excellent planning and organizational skills.
* Excellent oral and written communication skills.
* Ability to work in global environment.
* Solution oriented with ability to prioritize and work independently.
* Robust presentation skills with the ability to communicate complex issues clearly.
* Demonstrated ability to author and contribute to procedural documents.
* Ability to motivate and collaborate with multidisciplinary teams.
* Relevant computer skills, including proficiency with Microsoft Office and tracking databases.
* Fluency in written and spoken English. 5EDUCATION, EXPERIENCE AND QUALIFICATIONS
* At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
* At least 5 years of experience in the pharmaceutical/biotech industry with at least 3 years in relevant pharmacovigilance/drug safety field
* Good track record of operating pharmacovigilance quality systems, processes and teams
* Experience with preparing for, hosting and responding to audits and regulatory inspections globally
* Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
* Knowledge of GXP quality and compliance requirements, pr