Description

Associate Director, Corporate QualitySyneos 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support. 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<div>JOB SUMMARY </div><div>Oversees the conduct of audits and conducts audits. Oversees hosting of customer audits and inspections and hosts customer audits and regulatory inspections. Provides inspection readiness training to staff. Provides consultancy on quality-related matters especially related to Computer Validation and associated Processes. May manage a team of auditors. </div><div>JOB RESPONSIBILITIES </div><div><div>General Profile </div><div><ul><li>Oversees the conduct of audits and conducts audits in accordance with QA SOPs and WIs </li></ul></div><div><ul><li>Responsible for generating own and reviewing and approving others’ audit reports. </li></ul></div><div><ul><li>Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs. </li></ul></div><div><ul><li>Coordinates responses to customer audits of computer system validation and data integrity, and resolves issues with customers, where applicable. </li></ul></div><div><ul><li>Plans and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments (e.g. develops a program for and conducts ‘mock inspections’). </li></ul></div><div><ul><li>Develops and delivers inspection readiness training to staff. </li></ul></div><div><ul><li>Prepares for and hosts or supports Regulatory Authority Inspections in accordance with QA SOPs and WIs. </li></ul></div><div><ul><li>Coordinates the preparation and support activities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information. </li></ul></div><div><ul><li>Communicates findings from customer audits and Regulatory Authority Inspections of Syneos Health promptly to appropriate Syneos Health personnel and provides support on root cause analysis, corrective and preventive actions. </li></ul></div><div><ul><li>Provides consultancy on computer system quality and data integrity related matters. </li></ul></div><div><ul><li>Proposes strategies for improvements to quality and compliance of Operations and services. </li></ul></div><div><ul><li>May participate in and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, employee counseling and separations. </li></ul></div><div><ul><li>Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods. </li></ul></div><div><ul><li>May have line management responsibilities for staff members. If so, builds and maintains an organization that meets the needs of Syneos Health and its customers and ensures that their direct reports deliver against the budget, timeline, and quality requirements. </li></ul></div><div> </div><div>Functional and Technical Expertise </div><div><ul><li>Thorough knowledge of GxP Regulations pertaining to Computer Systems Quality and Data Integrity </li></ul></div><div><ul><li>Knowledge of Medical and technical terminology related to the audit types to be conducted. </li></ul></div></div><div><div><ul><li>Experienced as a Computer Systems Quality Assurance Professional with knowledge and experience in: </li></ul></div><div><ul><li>IT Infrastructure </li></ul></div><div><ul><li>Disaster Recovery and Back up </li></ul></div><div><ul><li>Information Security </li></ul></div><div><ul><li>Computer System Validation </li></ul></div><div> </div><div>Complexity </div><div><ul><li>Anticipates and resolves key technical, operational, or business problems related to non-compliance with GxP. </li></ul></div><div><ul><li>Applies critical thinking to identify solutions to non-standard requests and complex problems. </li></ul></div><div><ul><li>Well versed in personnel management, customer management and project management. </li></ul></div><div><ul><li>Interacts with regulators, customers, and other external stakeholders on quality related matters particularly in the area of Computer Systems Validation. </li></ul></div><div> </div><div>Supervision </div><div><ul><li>Supervises a team. </li></ul></div><div> </div><div>Other tasks </div><div><ul><li>Participates in local and / or company-wide special projects according to their skills or talents and the needs of the entire organization. </li></ul></div><div><ul><li>Participates in appropriate industry associations and other relevant forums </li></ul></div><div><ul><li>Coaches and trains company personnel in quality-related matters. </li></ul></div><div><ul><li>Develops and enhances QA SOPs and WIs. </li></ul></div></div><div><div><ul><li>Performs other work-related duties as assigned. </li></ul></div><div><ul><li>Minimum travel may be required (up to 25%). </li></ul></div><div> </div><div> </div><div>QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’) </div><div> </div><div> </div><div><ul><li>Requires a Bachelor’s degree in a science/health care field or equivalent with significant experience and expertise in all aspects of GxP quality assurance auditing. </li></ul></div><div><ul><li>Previous experience in the conduct of multiple audit types (e.g. vendors, computer system validation, trial master files, clinical data science, safety reporting, and laboratories) is essential. </li></ul></div><div><ul><li>Previous knowledge of Software Development Lifecycle, IT Infrastructure and information security is essential </li></ul></div><div><ul><li>Previous experience in a similar role is required. </li></ul></div><div><ul><li>Excellent knowledge of GxP regulatory requirements. </li></ul></div><div><ul><li>Computer literacy commensurate with job requirements (Microsoft Office suite; basic SharePoint proficiency). </li></ul></div><div><ul><li>Able to act independently and proactively. </li></ul></div><div><ul><li>Above average attention to detail. </li></ul></div><div><ul><li>Able to handle multiple tasks to meet timelines in a dynamic environment. </li></ul></div><div><ul><li>Strong organizational, presentation and interpersonal skills. </li></ul></div><div><ul><li>Excellent team building skills. </li></ul></div><div><ul><li>Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds. </li></ul></div><div><ul><li>Ability to negotiate and provide constructive feedback. </li></ul></div></div><div><div><ul><li>Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation. </li></ul></div><div> </div></div>Get to know Syneos HealthOver 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. <a href="http://www.syneoshealth.com" target="_blank">http://www.syneoshealth.com</a>Additional InformationTasks, 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.