Quality Assurance and Regulatory Compliance Manager

Manager, Quality Assurance and Regulatory Compliance - Sponsor dedicated - Based in Paris Area

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

Here at Syneos Health, we are looking for a Manager, Quality Assurance and Regulatory Compliance to work sponsor dedicated to a Top Pharma. You will have the chance to work in exciting studies. The job location will be Client Based at la Defense with Home Based days (2 or 3 days / Week).

The start date is immediate.

Key Responsibilities:

Audits & Inspections:

• Primary point of contact for Quality Assurance and Regulatory Agencies

• Manage and 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 look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plan.

Processes & Regulations:

• Local expert for ICH-GCP, local regulations and any quality-related process.

• 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 RCQM, CQM Lead and/or Process Owner (if necessary).

• Lead or Co-Lead global/regional /local key initiatives/projects/process improvement activities

Quality / Compliance / Privacy Issue Escalation:

• Communicate/escalate quality/compliance issues (incl. any potential trends) to local

country operations management, CQM Lead and RCQM as appropriated.

• Escalate significant quality/compliance issues and supports investigations (fact finding,

root-cause-analysis). Support the reporting of ‘Serious Breaches’ where applicable.

• Serve as local POC or supports local POC in case of escalations/reporting of Privacy

Incidents, if applicable

Clinical Supplies GCP Investigations

• Evaluate trends and coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).

Qualifications: 

• Bachelor's Degree or equivalent in relevant health care area

• Relevant experience in clinical research including direct field monitoring experience or management/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 leading / 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. )

Benefits

• Competitive remuneration package with excellent benefits
• Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
• Opportunity to work within a successful and rewarding environment

Are you interested?

If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/ 

 

 #LI-ZB1

About us:

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 30,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

Disclaimer:

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.

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.