Principal Professional, Quality Issue Management (Gcp)

Principal Professional, Quality Issue Management (GCP)Updated: May 16, 2024
Location: Mexico-Latin America - MEX-Home-Based
Job ID:24002485
Syneos 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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• 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.
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.
• Investigates QI 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
• Represents QI 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%)
Qualifications What we're looking for BA/BS degree in science or health care or equivalent education and experience, plus experience in Good Clinical Practice (GCP).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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn't align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 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 is a leading 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.
Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: ****** One of our staff members will work with you to provide alternate means to submit your application.
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