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 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, failures, etc. and drives integration across all relevant GRM activities.
• Maintains the failure investigation process across the GRM business teams, advises teams regarding RCA and proposed CAPAs, analyzes failure investigation data, and recommends options to drive continuous improvement.
• Works with GRM business leaders to explain the critical nature of the GRM quality program to their teams and helps drive a quality culture.
• Coaches and trains GRM business teams in quality-related matters and provides consultancy regarding quality and regulatory questions.
• Supports the Sr. Director/Director, Commercial, as needed and requested, with developing quality-related responses for pre-award Requests for Proposals (RFPs)/Requests for Information (RFIs) and post-award routine RFIs (i.e., sponsor due diligence quality RFIs/questionnaires).
• Supports the Sr. Director/Director, Commercial, as needed and requested, in review of GRM vendor and sponsor contracts and technical quality agreements, specifically verbiage for quality requirements and expectations, and seeks consultation from Corporate Quality as applicable.
• Establishes GRM quality and audit/inspection metrics and provides periodic updates to GRM business area leadership during governance meetings.
• Ensure EMA Regulatory Alignment: Interpret and apply EMA guidelines (GVP Modules V, XVI, and IX) to ensure that all GRM quality activities—including RMPs, aRMMs, and RMCs—are compliant with EU regulatory expectations and pharmacovigilance obligations.

Other:

• Directly responsible for supervision, management, and development of direct reports, ensuring optimal allocation of resources for coverage of work and objectives.
  Performs other work-related duties as assigned.

• 4 Year College Degree    
• Education Level Bachelor’s degree   
• Science/healthcare field, or equivalent combination of education, training, and experience required

Additional Qualifications

• 8+ years professional work experience in the health sciences or life sciences industry, with 5+ years of experience in a quality management or compliance related field required.
• 4+ years of experience in management role with key decision-making responsibilities and oversight of direct reports required.
• Knowledge of interpreting and applying GRM regulatory requirements specifically Risk Management Plans (RMP), Additional Risk Minimisation Measures (aRMM), and Risk Minimization Control (RMC) activities, highly preferred.
• Previous experience working on a Risk Management program preferred.
• Working knowledge of current Good Manufacturing Practices (GMPs), Post-Marketing Good Pharmacovigilance Practices (GVP), Data Integrity standards, and other applicable regulations.
• Working knowledge of EU GMP Guidelines (Published in EudraLex Volume 4, aligned with PIC/S), GVP Modules I–XVI, EMA GMP Annex + PIC/S Guidance, EudraLex Volumes 1–10, ICH Guidelines (e.g., Q9, Q10), EU Directives, ICH Q9 (R1) – Quality Risk Management, and ICH Q10 – Pharmaceutical Quality System and other applicable regulations, highly preferred.
• Experience with developing and implementing complex initiatives and processes in a highly matrixed environment in order to comply with regulations, reduce redundancies and risks, improve efficiency, and ensure ongoing process improvements to produce quality outputs.
• Experience with customer and internal audit preparation and support and ensuring ongoing audit/inspection readiness; Experience supporting vendor audits and regulatory inspections required.
• Experience performing complex root cause analysis and developing robust CAPA plans required.
• Experience authoring SOPs, work instructions, job aids, forms, and associated training presentations required.
• Experience tracking and trending quality data/metrics, developing reporting, and interpreting data to make decisions and recommendations to leadership and internal customers for risk remediations and process improvements.
• Experience with driving quality culture and change management across functions and departments.
• Experience with successful interactions and influence with various levels of stakeholders to motivate staff in a matrix structure to support company objectives, meet deadlines, and deliver high quality work in a dynamic environment.
• Working knowledge and proven experience applying EMA pharmacovigilance guidelines, particularly GVP Modules V and XVI, in the development and oversight of RMPs and aRMMs, highly preferred.
• Knowledge of ISO 9001 QMS standards a plus.

Critical Skills

• Reliable, responsible self-starter who works well independently and demonstrates excellent decision-making abilities.
• Highly organized with a keen eye for detail, accuracy, and quality product.
• Above average organizational, interpersonal, and team-oriented skills with strong 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.
• Demonstrates understanding of the workflow process, roles, and responsibilities of multiple functional areas.
• Excellent written and verbal communication, presentation, and analytical skills.
• Ability to lead effective meetings, working sessions and presentations to leadership.
• Ability to simplify dry/complex concepts.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and SharePoint. Willingness to embrace new technologies.

Other Requirements:

• Fully remote in Czech Republic.
• Willingness to travel/commute (< 5%) to the Prague, Czech Republic office for company meetings and events when requested. 
• Must have valid, current driver's license and passport, as well as the ability to secure corporate credit card. Ability to comprehensively manage periodic commute/travel to the Prague, Czech Republic office for company meetings and events as requested. 

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, you’re a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world. 

Work  Here  Matters  Everywhere  | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

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