Sr. Manager, Commercial Quality Excellence - Global Risk Management

Job Title: Sr. Manager, Commercial Quality Excellence - Global Risk Management

Job Location: Prague, Czechia

Job Location Type: On-site

Job Contract Type: Full-time
Job Seniority Level:

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.

- Serve as a Commercial Quality representative and subject matter expert, challenges the status quo, supports change management, and promotes a positive quality culture within the organization.

- 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