Global Operations Quality Manager

Syneos Health, Inc.

Job Overview

Location

USA-DE-Remote

Job Type

Full-time

Full Job Description

📋 Description

• The Global Operations Quality Manager at Syneos Health plays a critical role in ensuring the quality, compliance, and operational excellence of global clinical trial operations, directly supporting the company’s mission to accelerate drug development and improve patient outcomes by maintaining inspection readiness and driving continuous improvement across multinational studies.
• This role is essential to safeguarding data integrity and regulatory compliance, enabling Syneos Health to deliver reliable, high-quality clinical research that supports life-saving therapies and strengthens trust with sponsors, regulators, and patients worldwide.
• Day to day, the Global Operations Quality Manager will develop and maintain guidance and processes to support Development Operations Quality (DOQ) collaboration with study teams across global regions.
• They will lead the creation, delivery, and facilitation of GCP Lessons Learned, case studies, and trending analyses to promote organizational learning and prevent recurrence of quality issues.
• The manager will design and deliver training sessions on new or updated processes, ensuring study teams are equipped with current knowledge of ICH GCP, regulatory requirements, and internal quality standards.
• They will author and curate content for the DOQ SharePoint site, serving as a central knowledge hub for quality resources, SOPs, and best practices accessible to global teams.
• Acting as a lead on assigned DOQ workstreams, they will drive continuous improvement initiatives, identify process gaps, and collaborate with cross-functional stakeholders to implement sustainable solutions.
• In partnership with the Operations Quality Lead/Specialist, they will provide expert consultation on ad hoc requests, risk assessments, and non-compliance investigations, ensuring timely and evidence-based responses.
• The role involves developing, reviewing, and analyzing Key Quality Indicators (KQIs) and metrics to detect emerging trends, measure adherence to quality standards, and report insights to leadership.
• They will stay current with evolving clinical trial regulations, ICH GCP updates, and global health authority requirements to ensure all processes remain compliant and inspection-ready.
• The manager will facilitate cross-functional stakeholder engagement, building matrix relationships with process experts, clinical operations, QA, and regional teams to foster alignment and consensus on quality initiatives.
• They will collaborate closely with DOQ Leadership to ensure consistent messaging, integration of quality practices, and operational excellence across the organization’s global portfolio.
• By promoting a proactive culture of quality, continuous improvement, and operational excellence, they will empower colleagues to engage in open dialogue, raise concerns early, and contribute to a shared commitment to patient safety and data integrity.
• The Global Operations Quality Manager will operate within Syneos Health’s Clinical Solutions team, a group of seasoned professionals who apply deep therapeutic and operational expertise to solve complex challenges in drug development.
• They will join a purpose-driven organization where 25,000 colleagues are united by the ‘Driven to Deliver’ ethos — a commitment to shaping healthcare solutions that profoundly impact lives through innovation, collaboration, and relentless focus on quality.
• This role offers the opportunity to grow as a quality leader in a global, integrated life sciences services provider, gaining exposure to diverse therapeutic areas, complex multinational trials, and cutting-edge quality methodologies that are transferable across the healthcare industry.
• Success in this position can lead to advancement into senior quality leadership, regional DOQ roles, or broader operational excellence positions, supported by Syneos Health’s investment in career development, technical training, and mentorship programs.

🎯 Requirements

• Working knowledge of Quality Management methods, systems, and relevant procedures, including experience with SOPs, WIs, and quality frameworks in clinical research.
• Proven experience providing quality management within Study Teams for large, complex, multinational clinical trials across multiple phases and therapeutic areas.
• Demonstrated ability to lead and execute continuous improvement initiatives, including root cause analysis, process redesign, and stakeholder-driven solution implementation.
• Experience in inspection preparation, participation, and follow-up, including audits of sponsor/CRO/site/vendor interactions and regulatory readiness activities.
• Strong verbal and written communication skills, with the ability to convey complex quality information clearly and persuasively to diverse stakeholders at all levels.
• Acute attention to detail, critical thinking, and the ability to influence teams toward consensus while managing multiple priorities in a dynamic, multidisciplinary environment.

🏖️ Benefits

• Comprehensive health benefits including Medical, Dental, and Vision coverage to support employee and family well-being.
• Company-matched 401(k) retirement savings plan to help build long-term financial security.
• Eligibility to participate in the Employee Stock Purchase Plan (ESPP), allowing employees to invest in Syneos Health at a discount.
• Performance-based eligibility for commissions and bonuses tied to both individual and company achievements.
• Flexible Paid Time Off (PTO) and sick time policies, compliant with all applicable federal, state, and municipal regulations.
• Supportive culture focused on career development, inclusive practices, and recognition programs that reward contributions and foster growth.

Skills & Technologies

GCP

Remote

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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