Manager, Quality Assurance and Regulatory Compliance. Greece. FSP
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
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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.
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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.
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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
The CCQM position has a significant impact in achieving patient safety, high quality data and compliance with company requirements and regulations.
Under the guidance of the Regional Director, the CCQM oversees all CQM activities in the respective country/cluster.
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.
**Regulations & Processes: **
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Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
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In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
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Local expert for any quality-related local processes.
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Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
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Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level.
**Training: **
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Local training point of contact and the liaison between local country operations and MRL Learning & Development (L&D).
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In close cooperation with local country operations management, identifies / coordinates local training needs.
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Supports local trainings (as needed).
**Quality Control (QC) Activities: **
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In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
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In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
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On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).
**Audits & Inspections: **
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Primary local point of contact for MRL Quality Assurance and Regulatory Agencies.
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Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
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In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
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On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).
**Quality / Compliance / Privacy Issue Escalation: **
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Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
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Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
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Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.
**Qualifications: **
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Bachelor's Degree or equivalent in relevant health care area.
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A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
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Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
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Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
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Demonstrated experience in leading cross-functional teams.
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Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
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Ideally, experience in managing audits and inspections.
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Ideally, experience in coordinating and delivering training sessions.
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.