FSP Quality Manager

Work Schedule

Environmental Conditions

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, processes and measures.