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Associate Director, Corporate Quality
Syneos HealthProviding quality support and consultancy for internal and external customers in clinical research. Driving compliance and improvement strategies while managing account quality processes in clinical settings.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction.
- Provides quality oversight, support and consultancy for or within accounts, as assigned.
- Supports the internal account and/or operational teams on quality delivery and continuous improvement.
- Provides quality consultancy and support for project/program/functional/account level quality issues, audits, and inspections.
- Partners with the responsible person for account management and customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable.
- Investigates quality trends, potential risks and mitigations with key project/program/function and account team members.
- Drives solutions impacting results within an affiliate, site(s) or function.
Requirements
What you’ll need- University degree and professional experience or equivalent.
- Experience in a global clinical research, pharmaceutical, or Biotechnology Company preferred.
- Thorough knowledge of drug development and ICH GCP Guidelines is necessary.
- Experience in quality management and/or process improvement is essential.
- Comfortable working closely with customers.
- Effective at critical thinking and conflict resolution.
- Effective strategic planning, communication, written, presentation and analytical skills.
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.
- Experience working in a matrix team environment is preferred.
Benefits
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality OversightQuality ConsultancyDrug Development KnowledgeQuality Management Plan DevelopmentQuality Agreement Execution
Soft Skills
Conflict ResolutionEffective CommunicationAnalytical SkillsPresentation Skills