Description
Single Sponsor Manager, Quality Assurance - 2-3 days in London City
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
Audits & Inspections:
- Support activities during an audit/inspection.
- Perform, facilitate and manage root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports.
- On a regular basis support the Clinical Compliance Quality Management team with local trends, root-cause-analysis and local action plan. (as required)
Processes & Regulations:
- Local expert for ICH-GCP , local regulations and any quality-related process.
- Support CCQM to manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs.
- Identify process improvement opportunities and properly escalate to the CCQM Lead and/or Process Owner (if necessary).
- Support quality improvement activities upon request of the CCQM Lead/CRD.
Training:
- Support local training (as needed)
Quality Control (QC) Activities:
- Support CCQM in the coordination and proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP) , Quality Control Visits (QCVs), etc.
- Perform QC activities and site visits (upon request)
- Support CCQM with local trends, root-cause-analysis and local action plan (as required)
Quality / Compliance / Privacy Issue Escalation:
- Communicate/escalate quality/compliance issues (incl. any potential trends) to local country operations management and CCQM Lead.
- If indicated, escalate significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
Experience needed:
- Bachelor's Degree.
- Relevant experience in clinical quality management, plus direct field monitoring experience or operations management. And or oversight of such individuals, with a demonstrated record of accomplishments.
- Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
- Demonstrated experience participating in cross-functional teams.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Experience in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc. )
Working knowledge of digital and AI-enabled ways of working, including experience with tools such as Power BI, Power Apps, automation technologies, data analytics, and related digital solutions.
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.
http://www.syneoshealth.com
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.
