Description
Description
The Sr. Manager, Commercial Quality Excellence
- Global Risk Management (GRM) - Czech Republic is an experienced quality manager in the life sciences and/or healthcare industry who has responsibility for supporting the development and continuous improvement of an effective Quality Management System (QMS) for the Commercial division of the organization, specifically related to Risk Management Plans (RMP), Additional Risk Minimisation Measures (aRMM), and Risk Minimization Control (RMC) activities in alignment with European Medicines Agency (EMA) requirements for the European Union (EU) market. They take ownership of important quality initiatives, provide quality support and guidance to various Commercial business units and customer account management teams, continually seek to identify areas for process improvement opportunity, embody quality culture, and lead cross-functional teams in the design and implementation of internal processes and strategies that will optimize business outcomes and meet customer-specific requirements while ensuring alignment with the Syneos Health Quality Manual and regulatory requirements. The Sr. Manager, CQE- GRM is the fully-dedicated lead Commercial Quality Partner for the GRM business teams, managing and overseeing the Risk Management Plans (RMP), Additional Risk Minimisation Measures (aRMM), and Risk Minimization Control (RMC) activities quality program, including spearheading efforts for the business teams’ specific needs and objectives for continuous quality improvement, operational excellence, and audit/inspection readiness. The Sr. Manager, CQE- GRM is also responsible for supervision, management, and development of direct reports within the CQE team.
Core Responsibilities
Commercial Quality Excellence:
- Assists the Sr. Director/Director, CQE in the development, implementation, and continuous improvement of the Commercial division’s Quality Management System (QMS) with the primary goal of ensuring business processes meet the highest standards of quality, comply with applicable regulatory guidelines, and adhere to contractual customer requirements.
- Manages QMS implementation and process improvement initiatives by leading the activities of cross-functional teams in planning and operationalizing new or revised processes, ensuring timelines and milestones are met, and escalating obstacles or risks to the Sr. Director/Director, CQE.
- Reviews internal processes and documentation to verify they meet Syneos, customer and regulatory requirements, monitors KQIs/KPIs, facilitates action when metrics fall out of targeted range and escalates risks to the Sr. Director/Director, CQE.
- Proactively seeks out opportunities for process improvements and/or new processes and makes recommendations to the Sr. Director/Director, CQE for future Commercial Quality initiatives.
- Promotes adherence to internal process and contractual customer obligations and appropriately escalates issues or concerns to the Sr. Director/Director, CQE.
Global Risk Management (GRM) Quality:
- Serves as the fully dedicated lead Commercial Quality Partner for GRM business teams. Spearheads efforts to support the Commercial GRM business teams’ needs and objectives for management and ongoing improvement of the GRM quality program, recommends options to drive continuous process improvements and audit/inspection readiness, and ensures alignment of the GRM quality program with the overarching standards of the Syneos Health QMS.
- Organizes GRM internal process audits conducted by Corporate Quality’s QA group, including identifying internal process audits necessary for risk management and ensuring audit/inspection readiness.
- Assists with GRM vendor qualification audits as a Subject Matter Expert (SME) and document reviewer to support the Syneos Health Corporate Quality QA auditor, as needed.
- Leads and guides the Commercial GRM business areas through all stages of audits and inspections (sponsor, internal and regulatory) including audit preparation activities, addressing auditor questions and requests specific to the GRM quality program, tracking, and reviewing audit requests, and supporting responsible parties with finding root cause analysis (RCA), Corrective Action Preventive
- Actions (CAPAs) and Effectiveness Checks development. Tracks status of open CAPAs and Effectiveness Checks and may also be an action owner when applicable.
- Inspection Readiness for EU Market: Prepare GRM teams for EMA inspections and audits by ensuring documentation, processes, and training related to RMPs, aRMMs, and RMCs are audit-ready and aligned with EU expectations.
- Provides SME advice and support to the GRM business teams’ Controlled Document (CD) Liaisons and Authors and conducts a formal review of authors’ drafted CDs (i.e., SOPs, Work Instructions, Forms, Templates).
- Maintains the GRM Quality ontology model which codes internal and external stakeholder deviations, non-compliance, issues, fa