Manager, Commercial Quality Excellence

Description The Manager, Commercial Quality Excellence (CQE) – Deployment Solutions (DS) for Argentina is an experienced quality manager in the life sciences and/or healthcare industry who supports the development and continuous improvement of an effective Quality Management System (QMS) for the Commercial division. 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, providing quality support and guidance to various Commercial business units and customer account management teams. The Manager continually seeks to identify areas for process improvement opportunity, embodies quality culture, and leads cross‑functional teams in the design and implementation of internal processes and strategies that 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 units to spearhead efforts for continuous quality improvement, operational excellence, and audit/inspection readiness. The Manager 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 QMS, ensuring business processes meet the highest standards of quality, compliance, and contractual customer requirements. Collaborates and consults with the Corporate Quality department that provides independent oversight, guidance, and consultancy for QMS development, performs internal audits, and hosts customer audits and regulatory inspections. Serves as a Commercial Quality subject‑matter expert, challenges the status quo, supports change management, and promotes a positive quality culture. Leads as Commercial Quality Partner to commercial business units for continuous improvement, operational excellence, and audit/inspection readiness. Drives QMS implementation and process improvement initiatives by leading cross‑functional teams, 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 trends, providing guidance on remediation, and monitoring status of remediation plans. Reviews internal processes and documentation to verify compliance with Syneos, customer, and regulatory requirements, monitors KQIs/KPIs, facilitates action when metrics fall out of range, and escalates risks. Proactively seeks opportunities for process improvements and new processes and makes recommendations to the Sr. Manager, CQE. Supports the Commercial division through all stages of audits, including preparation, tracking, reviewing requests, and providing supporting parties with findings, root cause analysis, and CAPA plan development. Acts as the TrackWise System record owner for Commercial Audit CAPA and Quality Issue Action records. Authors job aids, operational guides, and controlled documents for the CQE functional area and performs quality review of drafts by Commercial CD authors. Supports the Sr. Manager, CQE with development of departmental processes, staff training, and delegation to direct reports. Serves on the CQE Functional Training Council to provide input on required training and may act as a temporary Functional Training Liaison. Promotes adherence to internal processes and contractual obligations, escalating issues or concerns to the Sr. Manager, CQE. Works with the Commercial division to find practical solutions to issues and process inefficiencies, ensuring remedies are completed timely. Directly responsible for supervision, management, and development of direct reports and interns, supporting rotational programs and optimal resource allocation. Performs other work‑related duties as assigned. Education Requirements Minimum/Preferred: 4 Year College Degree or equivalent combination of education, training, and experience. Education Level: Bachelor’s degree. Additional Qualifications 8+ years professional work experience in the health sciences or life sciences industry, with 5+ years in a quality or compliance related field. 3+ years in a management role with key decision‑making responsibilities and oversight of direct reports. General knowledge of current GMPs, GVP, Data Integrity standards, and other applicable regulations. Knowledge of REMS regulatory requirements or experience on a REMS program is a plus. Experience designing and implementing processes that streamline operations in a highly matrixed environment. Experience authoring SOPs, work instructions, job aids, forms, and associated training presentations. Experience with customer and internal audit preparation and support and ensuring ongoing audit/inspection readiness; experience supporting regulatory inspections required. Experience performing complex root cause analysis and developing robust CAPA plans. Experience tracking and trending quality data/metrics, developing reporting, and interpreting data to make decisions and recommend risk remediations and process improvements. Experience with successful interactions and influence across stakeholders in a matrix structure. Experience driving quality culture and change management across functions and departments. Knowledge of ISO 9001 QMS standards (a plus). TrackWise QMS software experience (a plus). Critical Skills Reliable, responsible self‑starter who works well independently and demonstrates solid decision‑making abilities. Highly organized with a keen eye for detail, accuracy, and quality product. Strong organizational, interpersonal, and team‑oriented skills with professional acumen when interacting with internal and external customers. Ability to perform several tasks simultaneously to meet deadlines. Flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as a team member and leader. Understanding of workflow processes, roles, and responsibilities of multiple functional areas. Excellent written and verbal communication, presentation, and analytical skills. Ability to conduct and effectively facilitate meetings, audit preparation, quality initiatives, and presentations to stakeholders. Ability to simplify dry or complex concepts. Practical real‑world approach and business savvy. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and SharePoint; willingness to embrace new technologies. Other Requirements Fully remote in Argentina. Willingness to travel/commute (