This role is responsible for managing the Complaints program while ensuring compliance with Seqirus procedures, and provides leadership support and guidance for the global complaints program including but not limited to stakeholder management, revision of global procedures, leading cross-functional meetings, operational activities both internally and externally to Seqirus. This role will also require providing instructor led training, continuous improvement exercises, compilation and distribution of metrics, initiation of complaints, trouble-shooting errors, owning change controls and CAPAs, and daily monitoring of the PTC Reporting mailbox. This role will support key stakeholders such as external partners, Pharmacovigilance, Commercial, Quality Systems, IT, CMO QA, MS&T and PTC Teams at each site to ensure compliance.
Complaint Program Maintenance
Execute routine reconciliation requirements with Pharmacovigilance and Risk Management (PVRM), Commercial Affiliates, Medical Information vendors and external business partners to ensure and document all quality complaints reported in market are received by Seqirus and investigated as needed.
Responsible for performing daily monitoring of centralized global complaint mailbox and actioning items as required including but not limited to batch mapping, intake and initiation of Product Technical Complaints (PTCs) and Batch Reviews and facilitating discussions between stakeholders.
Drive resolution to inconsistencies and/or compliance risks raised.
Responsible for revision of relevant routine Pharmacovigilance Safety Master File core and annex sections for Health Authority submission as well as Site Master Files in preparation of Health Authority inspections.
Manage complaint metrics by routinely updating, distributing and presenting material to stakeholders to align on global improvements and actions required while driving to optimize performance and visibility.
Prepare for and lead global meetings with cross-functional, high-level management to communicate current state of business, escalate risks and address non-compliances.
Drive global change controls and EDMS revisions of global procedures and work instructions
Communication and Collaboration
Represent Seqirus Quality in Complaint related discussions with cross-functional teams and external parties to maintain successful partnerships while ensuring compliance and continuing to progress a harmonized complaints program.
Drive engagement with external partners, Commercial Affiliates, Medical Information vendors and PVRM and Management to ensure all stakeholders understand and adhere to the requirements of the Complaints Program
Develop and deliver annual training to Commercial Affiliates to ensure campaign readiness.
Engage with PTC Site representatives to gauge and address business needs
Drive program improvement initiatives to optimize the business processes and practices within the Complaints Program including but not limited to CCIs, change controls, CAPA execution and any activities required by on-going maintenance/compliance of the Complaints Program.
Engage with IT technical team and TrackWise System Owner for trouble-shooting and system improvements to ensure business needs are met including but not limited to supporting development and risk assessments of system fixes, enhancements, and upgrades
Drive improvements of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and application of the Complaints Program
Interface with other Seqirus functions to share best practices and identify / leverage opportunities and best practices across the Complaints program’s TrackWise systems and processes/procedures
CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls
Support site and function audit preparations with respect to the Complaints program
Own investigation of deviations and CAPAs related to the Complaints Program
Own/support change controls related to the Complaints Program
Bachelor’s degree in scientific discipline/Life Sciences preferred or equivalent experience in biotech or pharmaceutical industry.
3-5 years’ experience in a GxP regulated environment within the industry, or equivalent required
3+ years of demonstrated experience with the development, maintenance, training and oversight of Quality Systems preferred
Understanding of Quality mindset – GDP, good distribution, practices including but not limited to Complaint handling and criticality of timely adverse event/special situation reporting
Experience with EU FMD requirements and Combination Products will be beneficial
Overall understanding of the organization and product line preferred
Prior experience with product complaints is desired.
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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