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Description
Principal Professional Quality Risk ManagerSyneos Health 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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.
Discover what our 29,000 employees, across 110 countries already know.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Job Responsibilities
General Profile
Provides 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.
InvestigatesQI related quality trends, potential risks and mitigations with QI Management
Contributes to or leads QI management process improvement initiatives, as assigned
Presents information to QI Management leadership, as applicable
Functional and Technical Expertise
Requires 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 opportunities
Advises 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.
Complexity
Solves 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 activities
Influence - Serves as a key resource to manage Qis. Gains support for ideas or positions on difficult issues
Problem Solving - Anticipates and resolve complex problems.Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problems
Impact -Drives solutions for products, processes, and services across a large business area
Customer/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 solutions
Project Management - Leads medium-scale, may lead large QI Management or Corporate Quality projects or programs with moderate risks and resource
Supervision
Normally receives little instruction on day-to-day work, general instructions on new assignments
Other tasks
RepresentsQI Management, as assigned
Performs other quality-related activities as directed by management
This position is not responsible for supervising employees
Travel may be required (approximately 15%)
QUALIFICATION REQUIREMENTS (please indicate if preferred)
BA/BS degree in science or health care or equivalent education and experience, plus moderate experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP). 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.
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
Provides 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.
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: 143698573
