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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
JOB SUMMARY
Overseesthe conduct of auditsandconductsaudits.Overseeshosting of customer audits and inspections and hosts customer audits and regulatory inspections. Provides inspection readiness trainingtostaff.Provides consultancy on quality-relatedmattersespeciallyrelated to ComputerValidationandassociatedProcesses.May manage a team of auditors.
JOB RESPONSIBILITIES
General Profile
Overseesthe conduct of audits andconductsauditsin accordance withQA SOPs and WIs
Responsible for generating own and reviewingand approvingothers audit reports.
Prepares for and hosts or supportscustomerauditsin accordance withQA SOPs andWIs.
Coordinates responses tocustomer audits ofcomputer system validation and data integrity, and resolves issues withcustomers, where applicable.
Plans andprovidesstrategies for assessing readiness ofSyneosHealth offices for potential Regulatory Inspections andconductssuch assessments (e.g.developsa program for andconductsmock inspections).
Develops and delivers inspection readiness training to staff.
Prepares for and hosts or supports Regulatory Authority Inspectionsin accordance withQA SOPs andWIs.
Coordinates the preparationandsupportactivities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information.
Communicates findings fromcustomeraudits and Regulatory Authority Inspections ofSyneosHealth promptly to appropriateSyneosHealth personnel and provides support on root cause analysis, corrective and preventive actions.
Provides consultancy oncomputer systemqualityand data integrityrelated matters.
Proposesstrategies for improvements to quality and compliance of Operations and services.
Mayparticipateinanddirect activities related to department staff operations such as interviewing andselection, professional development, performance management, employeecounselingand separations.
Works with andadvisesstaff on administrative policies and procedures, technical problems,prioritiesand methods.
May have line management responsibilities for staff members.If so, builds andmaintainsan organization that meets the needs ofSyneosHealth and its customers and ensures thattheirdirect reports deliver against the budget, timeline, and quality requirements.
Functional and Technical Expertise
Thoroughknowledge ofGxPRegulationspertaining toComputer SystemsQualityand Data Integrity
Knowledge of Medical and technical terminology related to the audit types to be conducted.
Experiencedas a Computer Systems Quality Assurance Professionalwith knowledge and experience in:
IT Infrastructure
Disaster Recovery and Back up
Information Security
Computer System Validation
Complexity
Anticipates and resolves key technical, operational, or business problems related to non-compliance withGxP.
Applies critical thinking toidentifysolutions to non-standard requests and complex problems.
Well versed in personnel management, customermanagementand project management.
Interacts with regulators, customers, and other external stakeholders on quality relatedmattersparticularlyin the area ofComputer Systems Validation.
Supervision
Supervises a team.
Other tasks
Participates in local and / or company-wide special projects according totheirskills or talents and the needs of the entire organization.
Participates inappropriate industryassociations and other relevant forums
Coaches and trains company personnel in quality-related matters.
Develops and enhances QA SOPs andWIs.
Performs other work-related duties as assigned.
Minimum travel may berequired(up to 25%).
QUALIFICATION REQUIREMENTS (pleaseindicateif preferred)
Requires aBachelor'sdegree in a science/health care field or equivalent withsignificant experienceandexpertisein all aspects ofGxPquality assurance auditing.
Previousexperience 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.
Previousknowledge ofSoftwareDevelopment Lifecycle, IT Infrastructure and information security is essential
Previousexperience in a similar role isrequired.
Excellent knowledge ofGxPregulatory requirements.
Computer literacycommensuratewith job requirements (Microsoft Office suite basic SharePointproficiency).
Able to act independently and proactively.
Above average attention to detail.
Able to handle multiple tasks to meet timelines in a dynamic environment.
Strong organizational,presentationand interpersonal skills.
Excellent team building skills.
Cultural sensitivityto alloweffective communication with stakeholders from diverse cultural backgrounds.
Ability to negotiate and provide constructive feedback.
Well-developed communication skills and the ability to write concise,accuratereportsand other necessary documentation.
Get to know Syneos Health
Over 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.
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.
Summary
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 and performs investigations on quality-related matters associated with Computer Systems & Vendor Quality. May manage a team of auditors.
INC Research/inVentiv Health has become Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Our new business addresses today’s market realities through clinical and commercial sharing expertise and data and insights to meet the needs of emerging and large global biopharmaceutical companies.
Job ID: 145003643
