Manager, Commercial Quality Excellence

**Description**

The Manager, Commercial Quality Excellence (CQE) - Deployment Solutions (DS) - Argentina 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. They are a strategic partner for the Commercial division and take ownership of important quality initiatives as defined by the Sr. Director, Commercial Quality Excellence, 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, specifically for the Deployment Solutions business area. They serve as lead Commercial Quality Partner to assigned Commercial business unit(s) to spearhead efforts for the business area’s specific needs and objectives for continuous quality improvement, operational excellence, and audit/inspection readiness. The Manager, CQE- DS -Argentina is also responsible for supervision, management, and development of direct reports within the Commercial Quality Excellence (CQE) team.

**Responsibilities**:

- Assists the Sr. Manager, 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.
- Collaborates and consults with the Corporate Quality (CQ) department that provides independent oversight, guidance, and consultancy for development of the QMS, performs internal audits, and hosts customer audits and regulatory inspections.
- Serves as a lead Commercial Quality Partner to Commercial business unit(s) to spearhead efforts for the business area’s specific needs and objectives for continuous quality improvement, operational excellence, and audit/inspection readiness.
- Drives 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. Manager, CQE.
- Addresses Commercial business risks/issues and quality non-conformances by performing root cause analysis, tracking/trending to identify systemic issues, providing guidance to responsible parties on appropriate remediation activities, and monitoring the status of remediation plans. May be assigned to lead remediation plans as applicable.
- 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. Manager, CQE.
- Proactively seeks out opportunities for process improvements and/or new processes and makes recommendations to the Sr. Manager, CQE for future Commercial Quality initiatives.
- Supports the Commercial division through all stages of audits (customer, internal and regulatory) including audit preparation activities, tracking, and reviewing audit requests, and supporting responsible parties with finding responses, root cause analysis and CAPA plan development. Tracks status of open CAPAs and may also be assigned as a CAPA owner when applicable.
- Performs functions of the TrackWise System record owner for Commercial Audit CAPA and Quality Issue Action records.
- Authors job aids, operational guides, and Controlled Documents (CDs) for CQE functional area and performs quality review of CDs drafted by Commercial CD authors. Verifies drafted CDs meet applicable policies, regulatory standards, plans/specifications, and customer requirements/expectations. Where applicable, ensures appropriate internal communication and training on CDs and supports activities to operationalize documented procedures within the business as required.
- Supports Sr. Manager, CQE with development of departmental processes within CQE, provides staff training, and delegates work to direct reports.
- Serves on CQE’s Functional Training Council (FTC) to provide input and decisions on essential required functional area (a.k.a. department) training and may serve as a temporary Functional Training Liaison (FTL) to support a Commercial business unit(s) that is in‑process of establishing their FTL and FTC structure.
- Promotes adherence to internal process and contractual customer obligations, and appropriately escalates issues or concerns to the Sr. Manager, CQE.
- Works with Commercial division to find