If you have a passion for quality and would like to be a part of a growing opportunity in a well-established company, the Corporate Quality Team supporting Syneos Health Commercial Solutions Division is looking for passionate team members with Quality Assurance and Quality Management experience to join our team. The role would include activities such as hosting and supporting client audits (strong focus in REMS and Pharmacovigilance), conducting internal audits across Commercial, trending and analysis of audit data, supporting enhancements to the Quality Management System in Commercial and helping to drive Quality Culture. Come be part of something amazing!
Syneos Health Audits
• Plans and conducts assigned audits.
• Performs For Cause audits as needed.
• Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.
• Prepares for and hosts or supports customer audits.
• Prepares for and hosts or supports Regulatory Authority Inspections.
• Serves as Lead Auditor on team-based Syneos Health audits.
• Serves as a trainer and mentor to less experienced QA Auditors.
• Provides guidance and training to operational staff on quality related matters.
• Writes, reviews or revises QA SOPs/WIs
• Applies critical thinking to identify solutions to non-standard requests and complex problems.
• Requires minimal instructions on day-to-day work and new assignments.
• May review audit reports of peers.
• May provide coaching and training to company personnel on quality-related matters.
• Participates in local and / or company-wide special projects according to his / her skills or talents and the needs of the organization.
• Involves himself / herself in appropriate industry associations and other relevant forums.
• Performs other work-related duties as assigned.
• Moderate travel may be required (max 25%).
Why Syneos Health
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
• #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? 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.
• Requires a Bachelor’s degree in the science/health care field or equivalent with significant experience and expertise in various aspects of GxP quality assurance auditing.
• Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is essential.
• Excellent knowledge of GxP regulatory requirements.
• Knowledge of Medical and technical terminology related to the audit types to be conducted.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Able to handle multiple tasks to meet timelines in dynamic environment.
• Strong organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to negotiate and provide constructive feedback.
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.
As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.