Sr Professional Quality Managament

Sr Professional Quality Managament 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 Summary Performs various activities (analysis, investigation, reporting, administration) related to ‘GXP’ (e.g. Good Clinical Practice or Good Pharmacovigilance Practice) and related topics for Clinical departments (therapeutic areas and functions). Core Responsibilities • Supports Clinical Monitoring (CM) teams through the duration of sponsor site audits • Work with CM teams for the preparation of site audits, which includes performing quality checks on training documentation/TMF/study documents. • Assist and work with CM teams during Audits and Inspections to determine underlying Issues, perform Root Cause Analysis (RCA), formulate appropriate Corrective and Preventative Actions (CAPAs), and implementing Effectiveness Checks. •Provides quality support and consultancy for Quality Management and Operations, as applicable •Works within a specific knowledge area. May work outside area. •Ensures commitments and timelines for assigned activities adhere to Syneos Health requirements. •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. Translates concepts into practice. •Makes decisions that impact a range of standard and non-standard operational, process, project or service activities •Serves as a key resource within a business area or discipline. •Anticipates and resolves problems, which may be moderately complex. Applies critical thinking to identify solutions to requests and problems •Drives solutions for products, processes, and services •Leads medium-scale Quality Management projects or programs with moderate risks and resource •Normally receives little instruction on day-to-day work, general instructions on new assignments •Represents Quality Management, as assigned