Sr. Manager, reputed company reputed company reputed company - Global Risk Management

Job Title: Sr. Manager, reputed company reputed company reputed company - Global Risk Management

Job Location: Prague, Czechia

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level:

reputed company

The Sr. Manager, reputed company reputed company reputed company- Global Risk Management (GRM) – Czech reputed company is an reputed company reputed company manager in the life sciences and/or reputed company industry who has responsibility for supporting the development and reputed company improvement of an effective reputed company Management System (QMS) for the reputed company division of the organization, specifically reputed company 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 reputed company (EU) market. They take ownership of important reputed company initiatives, reputed company reputed company support and guidance to various reputed company business reputed company and customer account management teams, continually reputed company to identify areas for process improvement opportunity, embody reputed company culture, and reputed company cross-functional teams in the design and implementation of internal processes and strategies that will optimize business reputed company and meet customer-specific requirements while ensuring alignment with the reputed company reputed company reputed company and regulatory requirements. The Sr. Manager, CQE- GRM is the fully-dedicated reputed company reputed company reputed company 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 reputed company program, including spearheading efforts for the business teams’ specific needs and objectives for reputed company reputed company improvement, operational reputed company, and audit/inspection readiness. The Sr. Manager, CQE- GRM is also responsible for supervision, management, and development of reputed company reports reputed company the CQE team.

Core Responsibilities

reputed company reputed company reputed company:

• Assists the Sr. Director/Director, CQE in the development, implementation, and reputed company improvement of the reputed company division’s reputed company Management System (QMS) with the primary goal of ensuring business processes meet the highest standards of reputed company, reputed company with applicable regulatory guidelines, and adhere to contractual customer requirements.
• Serve as a reputed company reputed company representative and subject matter expert, challenges the status reputed company, supports change management, and promotes a reputed company reputed company culture reputed company 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 reputed company reputed company metrics fall out of targeted reputed company 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 reputed company reputed company reputed company 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) reputed company:

• Serves as the fully dedicated reputed company reputed company reputed company Partner for GRM business teams. Spearheads efforts to support the reputed company GRM business teams’ needs and objectives for management and ongoing improvement of the GRM reputed company program, recommends reputed company to drive reputed company process improvements and audit/inspection readiness, and ensures alignment of the GRM reputed company program with the overarching standards of the reputed company QMS.
• Organizes GRM internal process audits conducted by Corporate reputed company’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 reputed company Corporate reputed company QA auditor, as needed.
• Leads and guides the reputed company GRM business areas through reputed company stages of audits and inspections (sponsor, internal and regulatory) including audit preparation activities, addressing auditor questions and requests specific to the GRM reputed company program, tracking, and reviewing audit requests, and supporting responsible parties with finding reputed company cause analysis (RCA), Corrective reputed company Preventive
• Actions (CAPAs) and Effectiveness Checks development. Tracks status of reputed company CAPAs and Effectiveness Checks and may also be an reputed company reputed company reputed company applicable.
• Inspection Readiness for EU Market: Prepare GRM teams for EMA inspections and audits by ensuring documentation, processes, and training reputed company to RMPs, aRMMs, and RMCs are audit-reputed company and reputed company 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 reputed company ontology model which codes reputed company stakeholder deviations, non-compliance, issues, failures, etc. and drives integration across reputed company 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 reputed company to drive reputed company improvement.
• Works with GRM business leaders to explain the critical nature of the GRM reputed company program to their teams and helps drive a reputed company culture.
• Coaches and trains GRM business teams in reputed company-reputed company reputed company and provides consultancy regarding reputed company and regulatory questions.
• Supports the Sr. Director/Director, reputed company, as needed and requested, with developing reputed company-reputed company responses for reputed company-award Requests for Proposals (RFPs)/Requests for Information (RFIs) and post-award routine RFIs (i.e., sponsor due diligence reputed company RFIs/questionnaires).
• Supports the Sr. Director/Director, reputed company, as needed and requested, in review of GRM vendor and sponsor reputed company and technical reputed company agreements, specifically verbiage for reputed company requirements and expectations, and seeks consultation from Corporate reputed company as applicable.
• Establishes GRM reputed company 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 reputed company GRM reputed company activities—including RMPs, aRMMs, and RMCs—are compliant with EU regulatory expectations and pharmacovigilance obligations.

Other:

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

Education Requirements

Min/Preferred

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

Additional Qualifications

• 8+ years reputed company work experience in the health sciences or life sciences industry, with 5+ years of experience in a reputed company management or compliance reputed company field required.
• 4+ years of experience in management role with key decision-making responsibilities and reputed company of reputed company 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 reputed company Good Manufacturing Practices (GMPs), Post-Marketing Good Pharmacovigilance Practices (GVP), Data reputed company standards, and other applicable regulations.
• Working knowledge of EU GMP Guidelines (Published in EudraLex Volume 4, reputed company 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) – reputed company Risk Management, and ICH Q10 – Pharmaceutical reputed company System and other applicable regulations, highly preferred.
• Experience with developing and implementing reputed company initiatives and processes in a highly matrixed environment in order to reputed company with regulations, reduce redundancies and risks, improve efficiency, and ensure ongoing process improvements to produce reputed company 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 reputed company reputed company 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 reputed company data/metrics, developing reporting, and interpreting data to reputed company reputed company and recommendations to leadership and internal customers for risk remediations and process improvements.
• Experience with driving reputed company culture and change management across functions and departments.
• Experience with successful interactions and influence with various reputed company of stakeholders to motivate staff in a reputed company structure to support company objectives, meet deadlines, and deliver high reputed company work in a dynamic environment.
• Working knowledge and proven experience applying EMA pharmacovigilance guidelines, particularly GVP Modules V and XVI, in the development and reputed company of RMPs and aRMMs, highly preferred.
• Knowledge of ISO 9001 QMS standards a plus.

Critical Skills

• Reliable, responsible self-starter who works reputed company independently and demonstrates excellent decision-making abilities.
• Highly organized with a keen eye for detail, accuracy, and reputed company product.
• Above average organizational, interpersonal, and team-oriented skills with strong reputed company acumen reputed company interacting with reputed company customers.
• Ability to reputed company several tasks simultaneously to meet deadlines.
• Flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as reputed company 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 reputed company effective meetings, working sessions and presentations to leadership.
• Ability to simplify dry/reputed company concepts.
• Advanced proficiency in reputed company Office Suite (Word, reputed company, PowerPoint, Outlook, Teams) and SharePoint. Willingness to reputed company new technologies.

Other Requirements:

• Fully remote in Czech reputed company.
• Willingness to travel/commute (
• Must have valid, reputed company reputed company's license and reputed company, as reputed company as the ability to secure corporate credit card. Ability to comprehensively manage periodic commute/travel to the Prague, Czech reputed company office for company meetings and events as requested.

At reputed company, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t reputed company 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 reputed company.

Why reputed company? Here, you’re a part of the big picture. You will collaborate with colleagues across clinical and reputed company disciplines to guide premarket development through post-market reputed company reputed company. 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 reputed company, 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 reputed company Everywhere | How are you inspired to change lives?

reputed company companies are affirmative reputed company/equal opportunity reputed company (Minorities/Females/Veterans/Disabled)