Principal Professional, Quality Issues Management Updated: March 22, 2024Location: Italy-Europe - ITA-Home-Based, ItalyJob ID: 24002072-ITA975JOB RESPONSIBILITIES General ProfileProvides support, consultancy and oversight on Quality Issues that occur across the organization during the performance of the services provided by both Clinical and Corporate.Leads root cause analyses and the implementation of corrective actions required to meet regulatory requirements.Participates in meetings with clients on the management of quality issues on their projects.Investigates QI related quality trends, potential risks and mitigations with QI ManagementContributes to or leads QI management process improvement initiatives, as assignedPresents information to QI Management leadership, as applicableFunctional and Technical ExpertiseRequires comprehensive business and technical knowledge/experience to improve management of QIs at Syneos Health.Ensures commitments and timelines for QI management adheres to Syneos Health requirements.Offers solutions to QI management issues and identifies process improvement opportunitiesAdvises Quality Assurance (QA) auditors and operational staff in providing QI information 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. May be assigned to support quality-related activities at an account/project level.ComplexitySolves complex problems and/or conducts complex analyses. Translates concepts into practice.Escalates issues to Corporate Quality leadership when required.Makes decisions that impact a range of standard and non-standard operational, process, project or service activitiesInfluence - Serves as a key resource to manage Qis.Gains support for ideas or positions on difficult issuesProblem Solving - Anticipates and resolve complex problems. Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problemsImpact - Drives solutions for products, processes, and services across a large business areaCustomer/External Focus - Establishes key relationships with those outside of business area.Assesses and interprets customer's (internal and external) quality needs and requirements and proactively develops solutionsProject Management - Leads medium-scale, may lead large QI Management or Corporate Quality projects or programs with moderate risks and resourceSupervisionNormally receives little instruction on day-to-day work, general instructions on new assignmentsOther tasksRepresents QI Management, as assignedPerforms other quality-related activities as directed by managementThis position is not responsible for supervising employeesTravel may be required (approximately 15%)QualificationsBA/BS degree in science or health care or equivalent education and experience, plus moderate experience in Good Clinical Practice (GCP) and/or Good Laboratory Practice (GLP). Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail. Above average attention to detail and accuracy. Strong organizational, interpersonal and team-oriented skills. Ability to act independently and pro-actively. Significant project management and customer management skills. Ability to perform several tasks simultaneously to meet deadlines.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.Discover what our 24,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients' lives around the world. Selecting us as an employer secures a career inwhich you're guaranteed to:Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.#J-18808-Ljbffr
