Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk M

Job Description

Job Description

The Senior Manager of Quality Standards and Compliance (QSC) will execute, under direction, tasks supporting the development, implementation, and oversight of quality and compliance aspects within Global Patient Safety and Risk Management (GPSRM).

Key Responsibilities

• Oversight and maintenance of the PSMF, including provision of content to support PSMF requirements, as assigned
• Act as a key point of contact between GVP Quality Assurance and GPSRM to ensure collaboration between departments
• Collaborate with GVP Quality Assurance to ensure completion of annual pharmacovigilance risk assessments and development of the annual audit plan
• Support PV audit activities on behalf of GPSRM in collaboration with GVP Quality Assurance
• Support PV regulatory authority inspection activities on behalf of GPSRM in collaboration with GVP Quality Assurance
• Facilitate the development, documentation, and monitoring of quality events (e.g., deviations, corrective and preventive actions, effectiveness checks, etc.) related to PV activities to address compliance risks and ensure timely closure
• Develop and report pharmacovigilance compliance metrics related to GPSRM activities to ensure oversight of operational performance and compliance with Key Performance Indicators (KPIs)
• Support the development and implementation of measures to manage compliance and oversight of external groups, vendors, and affiliates that impact GPS deliverables
• Oversee the late case process including investigations, root cause analysis and trending, correction development, and implementation
• Author, review, and/or approve content of controlled documents as needed and/or requested
• Work proactively with cross-functional teams to advance quality and compliance activities relating to PV

Skills & Competencies

• Demonstrated expertise in the principles and application of quality and regulatory compliance
• Strong communication skills with the ability to influence decision-making outcomes
• Up-to-date knowledge of industry trends, standards, and methodologies related to PV quality management
• Ability to conduct presentations on quality issues, initiatives, and projects at cross-functional meetings

Requirements

Qualifications

• Education: Bachelor’s degree in life sciences or related field
• Experience: Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on PV operations, quality, and compliance in a global environment. Knowledge of relevant global pharmacovigilance guidance and regulations (e.g., FDA, EMA, MHRA, Health Canada, and International Conference on Harmonisation (ICH) guidelines, including Good Vigilance Practices (GVP) guidelines). Experience in rare diseases therapeutic area at a global level is an advantage

Benefits

• Virtual
• Contract position with possible extension