Global Operations Quality Manager

Global Operations Quality Manager

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations. This position leads collaborations at country and regional level, as assigned. This position leads consultation on continuous improvement of established processes and procedures. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. This position may sit across the entire global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) and the Qual ity Lead/Specialist, as needed. With QA leading, this position supports study teams during regulatory inspections.

General Responsibilities

• Develop and maintain guidance and process to facilitate DOQ support of Study Teams
• Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
• Provide training or awareness for new or established processes or guidance provided by DOQ
• Collaborate in developing and presenting DOQ content for distribution within the organization
• Author relevant content for the DOQ SharePoint site
• Act as lead on specified DOQ workstreams or assigned DOQ initiatives
• In collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQ
• Consult, develop, or identify opportunities for continuous improvement projects
• Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations
• Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
• Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
• Develop matrix relationships to involve process experts and conduct improvement activities
• Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization
• Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do Skills/Experience
• Working knowledge of Quality Management methods, systems, and relevant procedures
• Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials
• Experience in managing complex and sensitive operational challenges
• Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements
• Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders
• Experience in developing or contributing to processes and/or SOPs and/or WIs
• Ability to lead and execute continuous improvement
• Experience in inspection preparation, participation, and follow-up
• Experience with audits and inspections of sponsor/CRO/site/vendor
• Exposure to all phases of clinical trials
• Broad knowledge of Clinical Operations with prior regulatory knowledge desired
• Demonstrated leadership, critical thinking skills, and ability to influence teams driving them to shared consensus
• Strong verbal and written communication skills with ability to effectively communicate with a broad range of stakeholders at all levels to build strong, positive relationships under challenging and evolving landscapes
• Ability to interact with key stakeholders and create and present complex information effectively to promote excellence in quality
• Acute attention to details with ability to extrapolate facts and communicate succinctly and confidentially
• Strong cooperative team player with the ability to be flexible and adapt to a changing environment
• Used to working in a multidisciplinary setting with a strong customer-orientation
• Ability to effectively manage multiple priorities simultaneously
• Good planning, prioritization, and organizational skills, and able to work independently or within a group

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations. This position leads collaborations at country and regional level, as assigned. This position leads consultation on continuous improvement of established processes and procedures. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. This position may sit across the entire global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed. With QA leading, this position supports study teams during regulatory inspections.