Regulatory Affairs and Quality

3 weeks ago

United Kingdom Syneos Health Full time

Senior Professional, Quality Management


Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.


Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.


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 accelerate the delivery of therapies, because we are passionate to change lives.


We are passionate about developing our people, through career development and progression; technical and therapeutic area training; peer recognition and total rewards program.
We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Provides quality support and consultancy for Quality Management and Operations, as applicable
Offers solutions to process and quality related issues and identifies process improvement opportunities
Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
Solves moderately complex problems and/or conducts analyses. Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
Leads medium-scale Quality Management projects or programs with moderate risks and resource
Represents Quality Management, as assigned
Performs other quality-related activities as directed by management
Travel may be required (approximately 15%)
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.
Significant project management and customer management skills.
Further, nothing contained herein should be construed to create an employment contract. 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. #

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