Global Quality Specialist / Manager at IQVIA

Job Title: Global Quality Specialist / Manager

Company: IQVIA

Location: Primary Location: London, United Kingdom. Additional Locations: Amsterdam, Netherlands; Frankfurt, Germany; Warsaw, Poland.

Job Type: Full Time

Job ID: R1383796

JOB DESCRIPTION: IQVIA is seeking a Global Quality Manager or Specialist for International Pharmacovigilance (IPV) Affairs CAPA Team, with the option to be based in the UK or anywhere in Europe. This role is an individual contributor assigned to a designated Delivery Unit, sponsor, or business line.

RESPONSIBILITIES:

General:

• Serve as a Member of the Global IPV Affairs Team.
• Act as a Subject Matter Expert for the IPV organization in your designated areas of responsibility. Drive or support finding the most suitable and efficient solutions during discussions with different cross-functional teams and collaborate on reviewing and streamlining applicable procedural documents.
• Support the IPV organization on applicable operational tasks and ensure overall inspection readiness across IPV.
• Work closely with IPV Affairs members across regions to ensure a globally consistent approach for IPV.

CAPA Management:

• Serve as a Member of the Global IPV Affairs CAPA (Corrective Action and Preventive Action Plan) Central Support Team.
• Own and coordinate Quality investigations/Quality Issues (QIs) and related records (CAPAs/Corrections) on behalf of IPV personnel – Originating from Self-Identified Quality Issues, Audit Findings, and/or Inspection Observations.
• Coach relevant stakeholders through the applicable QI processes.
• Support in writing investigations and conducting root cause analysis to ensure high quality, consistency, and accuracy of content.
• Collaborate with Medical Safety Teams/LSOs, Case Management team members, and other relevant stakeholders to identify appropriate solutions to mitigate non-conformances and prevent recurring issues.
• Maintain oversight of IPV-owned records and ensure timely completion and closure of records.
• Act as a Subject Matter Expert within IPV for all matters related to QI and CAPAs, providing advice or support on questions/concerns related to it.
• Review audit and inspection reports and support trending of observations to lead to overall global improvements.
• Support IPV in maintaining audit and inspection readiness for all IPV related activities.
• Support IPV Audit and Inspection RFI coordination – provide ETS Local, Regional/Global QI data as needed.

EDUCATION & EXPERIENCE REQUIREMENTS:

• Medical, pharmaceutical, or life science degree with proven expertise and experience in the pharmaceutical industry and experience in Pharmacovigilance.
• Minimum of 1 year’s experience in a position within Pharmacovigilance plus 6-8 years of related experience.
• Excellent stakeholder management, negotiation skills, and coaching people in influencing internal and external partners.
• Task-oriented with proven experience in the delivery of high-quality work as part of a multi-disciplinary team.
• In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this role.
• Demonstrable insight into the development of regulatory requirements with knowledge of Global aspects of drug/cosmetics/devices safety, including international reporting requirements and relevant country-specific variations.
• Excellent computer-based application skills.
• Fluent communication skills in English; any additional language is a plus.

Location & Travel:

• Global Office-based role from any Pharma office in the correspondent region. Remote work is possible.
• Up to 25% travel might be required.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com.

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